Patent US B2 Nag Date of Patent: Ang

IIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIIUS011107578B2

(12) United States PatentNag

(10) Patent No.: US 11s107s578 B2(4s) Date of Patent: Ang. 31, 2021

("

) Notice Subject to any disclaimer. the term of tluspatent is extended or adjusted under 35U.S.C. 154(b) by 605 days.

(21) Appl No 15/019,73(l

(22) Filed: Feb. 9, 2016

(65) Prior Publication Data

US 2016/0267238 Al Sep. 15. 201(i

(54) STSTEMS .AND METIIODS FORFACILITATING HEALTH RESEARCH

(71) Applicant. Apple Inc., Cupertino. CA (US)

(72) Invmttor Divya Nag, Palo Alto, CA (IJS)

(73) Assignee: Apple Incr Cupertino, CA (US)

(sc)

(')CN

Refcrcnces Cited

IJ S PAI'I(N1 IX)('IJMIINT)

6,820,0s Bi8,005,&i91 B28,157. 30 B2s

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l(its'/3520 4 3 2(109101667224 4 3p2010

(Continued)

0'l3 II IR PI.JI II I('A'I IONS

I I 20(14 I och ct al8/2011 Kunssr et al4 20I2 I.cuockkf (ii6B 10 &io

600p30042013 Muxa42014 Quy A61B Sp6838

600t520I 20(4 Brynclscn ct alSp2014 Van Rooyen et al

(Continued)

Related U.S. Application Data

(60) Pro visiooal apphcauon No. 62/129k691, filed on Mar.6. 2015

(51) Int. Cl.GI 6H 40/6.3 (2018.01)GI 6H 10/60 (2018.01)G161/ 40/67 (2018 01)G1611 70/Z0 (201 8 01)

(St2) IJ.S. CL('PC . 6'r1611 4&I/63 (2018.01); GI611 10/6(I

(2018 01): G16H 40/67 (2018 Oi): ('16H70/20 (2018.01)

(58) Field of Classification 'Search('P(' (T1611 10/00—65, (ii 611 40/63( (T1611 40/67,

Cil6H 70/20; Ci06F 19/3418; Ci06Q50/22 24

iJSPC 705/2—3

Sce appltcauon lile for complete search lnstory.

"Non-I'mal Oflice Action*t i. S Appl No ISP014.856, dated Nov

15. 2018. 17 pages

(Coll(((load)

i'ri mar) I:'xomi acr Michael 'lixmaszewski

(74) .It&oracy, .4gettt, or Firot Ktlpatrick Townsend aStockton I,I,P

(5 I) ABSTRACTMethods and systems for facilttaung health research throughetnhanced conununication between research participants andresearchers. Methods include communication of informationrelated to a research study to a portable computing dek ice ofa research participant by use of an appl(cat(on frameworkand onc or more modules. The onc or morc modules nmy bepro vnlcd with thc appltca non framework or may tnclude oneor morc modules lbom tlnrd-party rescarchcrs so as to allowstandardization of contnntnication front multiple researchstudies and ditfering research factlities

36 (Jlaims, 26 Drawing Sheets

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US 11,107,57S B2Page 2

3563 References f:ited

U.S. PATENT DOCIJMENTS

8.818,823 B2 8"2014 Ackerson e( al8,930,221 B2 (1201( Patterson ct al8.961,414 B2 ' "2015 Tellei

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2001/003210020021000(9352003 0028400200310074221200(,lo I 9 (774

B2 4 2015B2* 2 2017Al Io 2001A I I "2002Al 2 2003Al 4 "200A I * 1012003

Hutcluson et alKeenMahmud et alRobinChest et alCluisi e( alAbbo

2004l(¹476(l A I 312004 Fwing ct al2005 0049898 Al 3 2005 Huakalva200( 01917903 A 1

* 9 200( Hoffman

G16H 201 0&ioo 301

G061 16 22

(316H lol6070513

(ioob 19 34(6705 2

20(3 02 (1st Al2013l0304511 Al2014/0081662 Al20(4 0122125 A I

2014101 5592 Al20 (4 0242698 A I

2014l02(78(I AI20(4 02 6((2 A I

2014l0278474 Al2015/0242592 Al201(l02448(2 Al201510294090 Al l

201510347499 Al20(( 0347684 Alr 0 I ( '0347690201510347784 Al20(6l02(0416 Al2016/0301792 Al20(7 001 HKZ Al

10 201311 20133/2014( 2014512014820149/20149 20149 20148/20158/2015

1012015

121201512 201(11/20151212015

7 201610/2016

I 2017

Mooic et alGunterBradnck e( alDcshpanldc ct alOhnemus et alSouthWalker et alXguycn ct alXfc&'lure et alWelss e( alEnckson et alkodlyan

keen et alKeen ct alKeen et alkeenWhltehurstLee e( al9 hltchulst

COO& 19/OO

70512

2006'0064030 Al 3 "2006 Cosenuno et al2006/0248593 Al I f2006 Dennis et al200610282292 Al '2"2006 Bnnk

201010120585 Al '"2010 Ouy

G16H 1016070(l3

G16H 40167482l8

CNWO

FOREIGN PATENT DOCUMENTS

10318217( A 7120132015/18349( 1212015

2011 029(616 Al 12 2011 Vesto2012 0101847 A I 4 2012 Johnson ct al2011/0313776 Al 12 2012 Itttei et al.201310030836 Al ' "2013 Ackerson

2013100643(8 Al 3 "2013 Nusbaum2013 01917942 A I 8 2013 ('hiu et al

G06O 50124705 3

O'I'I HIR PUIII I( AT IONS

"OITice Action*k China Pa(ent Appbmulon No 2015800287269,dated Jul 31, 2017, I( pages

'" cited by examiner

U.S. Patent Aug. 31,2021 Sheet 1 of 26 US 11,107,578 B2

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1st Party ApplnFramework 106

3rd Party Modules Researcher

Survey Info onresearch presentedto User

User input

Consent documentationsent to researcher

FIG. 3


FIG. 4


FIG. 5A FIG. 5B

FIG. 5C


FIG. 5D

FIG. 5E


FIG. 5F

FIG. 5G FIG. 5H


FIG. 5l FIG. 5J

FIG. 5K


FIG. 5N

U.S. Patent Aut,*. 31,2021 Sheet 11 of 26 US 11,107,578 B2

FIG. 6A

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FIG. 6M

FIG. 6N

FIG. 60


FIG. 7A

FIG. 7B

FIG. 7C

U.S. Patent Aut,*. 31,2021 Sheet 16 of 26 US 11,107,578 B2

FIG. 8A

FIG. 8B FIG. 8C


FIG. 8E

FIG. 8F


FIG. 9A

FIG. 9B FIG. 9C


FIG. 9D FIG. 9E

FIG. 9F FIG. 9G


FIG. 10A

FIG. 108 FIG. 10C


FIG. 10D FIG. 10E


FIG. 11A

FIG. 11B FIG. 11C


FIG. 11D FIG. 11E

FIG. 11F



FIG. 13


FIG. 14

US 11,1

1

SYSTEMS AND METHODS FORFACILITATING HEAI.TH RESEARCH

CROSS Rl ilqiRIIN('I if 'I'0 REI A'I'I iDAPPLICATIONS

The present application claims the benefit under35 J.JS('119(e) of 1.1 S Provisional Appln No. 62/129.6') I

filed Mar. 6. 2015; the full disclosure ivhich is incorporatedhcrcnl bv Icfcrcncc nl lls cnlaclv Iol Bll purposes.

The present application is related to U.S. 62/006,031 filedMay 30. 2014; U.S. Ser. No. 14/499,449 fllcxi Scp. 29. 2014,and U S. Ser. NO 14/499.519 filed Sep. 29, 2014; the entirecontents of each arc hcrcby Incorporated by rcibrcnce for allpllfposes

I'l II,D Oil iNVI JN'I'ION

'Hie present invention relates to systems and methods forfacilitating health research throuJt enlmnced collection andcommumcanon of health Inl'ormatlon berwcml research par-ticipants and researchers.

BACKCiROUND OF THE INVENTION

'lradilionally, health research studies involve exchangesof B nlulnludc of nllorniallon between paltlclpBBH Bndresearchers, usually in written form )uch studies oftenrequire an initial in-person visit to ensure informed consentis rixelved befi&re the study conuncnces after w luch periodicor follow-up visits may be requirixk Current research studiescml be complex and fragmented resulting in redundanciesand inetficiencies in collecting data that frustrate both userand researchers In addition, the pmcesses by which partici-pants are recniited. consent is obtained and research con-ducted varies v,idely between research ihcilities. rherebyfurther comphcanng attempts to make lhc processes byw'hlch rcsclirch B conduclcil niorc clilclcnl.

Allhou h the developnlent of electronic medical recordand secure comnlunication of medical inti&rmation hassonleivhal improved exchange of health information forpurposes of treatments and research. the initial participantrecruiting and consent is still typically perfonued in an officesclnng and ulvolvcs review and collccnon ol research dis-closures in wnttcn form. The inconvenience of flus aspectreduces the participant pool such that health research studiesenemlly have linlited, if not insuflicient„nuinbers of par-

ticipants. In recent years, acquisition of health infornlationand various health metrics outside of the electronic medicalrecords has increased dmsmatically. The usefulness of suchhcdlfll hlfollnallon, howcvcn ls hnlllcd given thc conlplcxl-ucs mid burden associatixl with disscmuwuon 01'such largeamounts of information While recruitment of health studyparticipants and health information obtained during researchstudies can be improved by utilixing a wider range of healthinformation noiv available. providin these improvement Ischallenging and ofien problematic given the limited timeand resources available in modem hcalthcarc m adihnon tohelghlcncd concerns Bs to user pnvacy.

BRIEF SUMMARY OF THE INVENTION

Mcllx&ds ol the prcscnt invention pcrlam lo faclhlalulgresearch by improved communication bc(ween thc reswirch-ers and research participants In one aspect, the systenlincludes an apphcation frainework on a portable computing

07,578 B2

ilcvlcc ol ii Icscarch plirnclpllnl fllBt pcrfornls vallousresearch Objectives using one or more modules receivedv ithin the framework

In one aspect, the invention provides a method for facili-tating health research that includes steps of: receiving, witha portable computing device, one or more module~ relatinto a health research study. the portable computing deviceassociated with a user pnrtmipating In the health researchstudy; disphsying, on a raphical user interface of the

10 portable computing device, a user instruction based on arespective module of the one or more nlodules: receiving aninput v ith the portable computin device in response to theinstruction: and outputting to a third party health researcherthc input associated w'lfll Ihc nlslrucnon of fllc onc or niolcmodules for usc ul health research rclaung to thc study. Insome embodiments. the methods further includes a step ofde-identifying the user input from the user before outputtingto the third party health researcher. I'he portable computing,device may be a smartpln&ne, tablet. laptop, a computer and

10 the hke. Health research facilitated by such methods includeObservational prc-clilucal. clilucal. or post-chnical studiesfor tele-nlonllollng Icscilrch.

In some embodiments, Ihe input composes a user inputentered by the user on the graphical user interface of thedevice or an output of one or more sensors associated iviththe portable computin device. The one or more sensors maybe Incorporated into the portable computin device or maybc separate from and conunumcauvcly coupled with thcportable computing de&Ice. In some cmbodunents, thc onc

10 or more sensors separate from the portable computing,device include a iveamble sensor device configured to detecta sensor parameter over a duration of tinle and transmit thedetected sensor parameter to the portable computing device.Such sensors may be configured for detecting any of:

&I activity lcvcl, activity ndckulg. respiration. body tempera-ture, heart wcllncss data, hydranon lcvcls, pcrspiranon,blood glucose, salinity, sleep cycles, posture, 0, lcvcls,nniscle engagement, or any combination thereof I ixamplesof such sensors includes accelerometers. gyroscopes. mica&-

40 phone/audio sensors, a camems/CCD, a photoplethysmogram(PPCi) sensor or any combination thereof

In some cmboihmmlts, reccivin thc Input comprisesrccclvlng sensor laid flout onc or nlorc sensors ovciduration ol'ime. In onc aspect, rccclvlng thc sensor datamay further include nleasuring a sensor paranleter based ona user interaction, while in another aspect. receiving thesensor data comprises passively collected sensor data fromthe one or more sensors lvithout requinn user interaction.

In onc aspect, lhc methods utihxc B portable compululg0 ilcvlcc having B firsl-party'pphcdnon fl'dnlcwork fllcrcon,

tluough wluch lhc onc or more modules arc communicatcxito the user. 'lite modules may include a first set of modulesthat are first-party modules. developed by the same entity asthe application framework. or third-party modules devel-

&1 oped by another entity. such a third-party researcher. Themodules may be configurlxl ul venous dlifi:rent types.includes a survey module,;m acuvlty or task module, aninfi&rmcd consent module. or a passive data collccnon mod-ule I'he survey modules may include a question or series of

io questions relating to an attribute or status of the user. asymptom experienced by the user. a temporal aspect of anactivity associated with the user, or a history of medicationOr discase of lhc user. The dctn ity or task modules mayinclude an inslrucuon lo pcrionn an Bcuvity concurrent with

ss monitoring ol'ensor data. Examples of activity modulesinclude a fitness test nlodule. a ait test n&odule. a phonationtest module, a menlory test module, and a finger tapping test

US 11,107,578 B2

nloilUlix Thc hllornlixl consent nloihllL'lchlilcs a dlsplily'fa description of the research study being facilitated On theportable computing device In some embodiments, themethod includes receiving a set of modules from a third-party health researcher through a server conuminicarivelycoupled with the pottable device. The set of modules mayinclude venous rcscarch survey acuvilics or dale collecnontasks or may include follow up quesnons/queries based onuser input received in response to a previously performednlodule

In sonic embodiments. the modules received by the sys-tem include a recruitment step module having one or morequestion steps relating to eligibility for participation in thehealth research study, whcrcin dtsplayulg the user inslruc-Uon compnses rixNcsttng ulfonnalton of Ihc user corre-sponding to eli ibility as a participant The one or nmrequestion steps may include inquiries in regard to any Ofweiuht, aue race, demographic. activity level, diet, sleep,family history. symptoms, disease status/history. medicalstatus/characteristic/history. medication history. or any com-bination thereof.

In other embodunmils, Ihe modules mdy ulclude a consentnlodule that displays a user instntction that requests consentof the user, v ith the portable computing device. for partici-pation in the health research study after performing therecruitment module. The consent module may include infor-mation corresponding to a consent document associated v iththe rcscdrch study und may include a visual consent step andd consent review step. Thc visual consmu step comprises asequence Of displays or illustrations of information relatingto any of: an information survey of the research study. datagathel'ill, pl'IVBCyl USC Of parti Clpallt data, tunL'olnini tnletrtby participant. a description of study task~, withdrawal fromthe study, or any combination thereof. In some embodi-ments. Ihe consmil module may I'urlhcr include pcrfilmlingol an cngagcmenl lest dunng Ihe visual conscn! slap,Aft:li:ul lhc cngagcnlcnl li:sl conlpllscs: provlihng Bninstruction to nlove the portable computing device accordingto a particular movenlent (e g. shaking or tilting the devicejand concurrently monltorin a sensor parameter to verifyperfonnance of the instruction. In another aspect. thei:ngagcnlcnl test nldy ulvolvc lrackulg ol lhc ilscr s cvi:s 10

confunl i:y'c Bi:nvlty I:onslslcnl with actUBI Iialilnl ol thcconsmll disclosures In other embodiments, Ihc consmllmodule may further include performing a comprehensiontest during the visual consent step betilre proceeding v iththe consent review step. wherein the comprehension testcomprises; displaying one Or more questions re arding theinlonnalion displayed dumng Ihe consent slcp mid concur-rently monilomng a sensor parameter filat mcludcs prcssureby manual louchuig ol'hc display lor lo vcnfy a selcctcdansiver of the comprehension test I'he consent review stepnlay include displaying information regarding consent filrthe research study in accordance with applicable guidelinesand displaying a consent form such that the input receivedwith the portable compuung device is indicative of consmllof lhe user lo participate ui thc study, for cxmnple the filnnnldv bc d signa lUI'L fickl thai I i:cclvcil an clccniinli: signa! Urcof the user that indicates consent.

In sonic enlbodinlents. the modules may include a surveytest module that includes one or more question steps pre-sented concurrent v ith sensing a parameter of one or moresensors. lite onc or more qucsuons may corrcspond lo asclccnon of Bny oil scale. Boolean, picked value, lexlchoice. Uunu:rical choice, temporal value, open-ended lexlansiver format, or any colnbination thereof I or exanlple. thesensed paranleter may be pressure and/or sliding movement

COIICSponilulg lti nlallotil lilUChulg Of II graphlCBI ilgplaVscreen and the one or more sensors colnprise pressuresensors ivithin the portable computing device

In some embodinlents, the One Or more niodules includeactivity or task modules that provide instniction to perfomla spemfic task or activity concurrent with monitoring sensorilala 10 nlcilsulc B pdranli:ICI ilUnng pi:rfornlani:C Ol lhc'. IBSk

or activity. Such activity or task modules may includevarious types of tasks or activities In one exmnple. the

IB activity module comprises a nlemory test module thatincludes an instruction to indicate a sequential order of anammation on a yaphICBI user interface displace of theportable computing device concurrent with monitoring asi:ascii ptudnlclcl floni ont: ol nlorc si:nsors Fol cxanlplc, II

plurality of itcnm may appear or bc emphasized in a par-ticular Order afier which the user Is mstntcted to mimic theorder in which the items appeared by selecting the items iula graphical user display of the portable computing deviceHere. the sensed parameter may be pressure and/or slidin

10 movement corresponding to manual touchin of a raphicaldisplay scrccn and lhe one or morc sensors compnsc prcs-sure sensors within Ihc portable computing device. Inanother example, the activity module nlay be a fitness testnxldule that includes an activity task including an instnictionto v alk a pre-determined duration concurrent with monitor-ing of sensed data from one or more sensors For example,in one embodiment, the monitored sensed data compriseshciirl rdtC UILIISulixl bv' PPG SCnsor Bnd B Idli: 01 Wdlkulgmcasurcd by an accclcromeler. In yet unothcr example. thc

10 activity module may include a speech or phonation testmodule including an instniction to vocalisc into an audiosensor associated lvith the portable device concurrent ivithmonitorin of sensed data front the audio sensor. Here. thesensed data is any of volume. duration and speech pattern or

is any combulalion thcrcof. Ihe audio sensor, such as a micro-phone of Ihc portable computing device. In still anotherexample, thc activity module may bc a balance or gait lealnxldule including an instmction to walk and/or stand stillcmlcurrent v;ith monitorin Of sensed paranleters with one

do or more sensors on the user. The sensed parameters may bemovement and/or balance and the one or more sensorslnchlili: onc 01 nlorc dccclcronlcti:rs. In still tinolhi:Icxiunplc, lhe activity module may bc a tappuig Ical modulefor dctcnnintng manual dexterity and/or coordulauon. Here.the sensed parameter nlay be pressure fmm nianual touchingof a graphical display screen of the portable computing,device and the one or nlore semor comprise pressure trans-ducers of the portable computing device.

In another aspect, systems for facthtatuig health research0 are provulmi hcrcin. Such system muy uicludc. a portable

computing device operable by a user or an assocrdlcxlcaretaker, the portable computing device includulg a wire-less communication module for transmitting to and receiv-ing data from a third-party researcher: a processor of the

ss portable computing device, the processor having a computerrcadablc medium having stored thcrcon computer execut-able Instructions conligurcd for. rcccivlng onc or morcmodules relating lo d health research study, dmplayulg, on agraphical user interface of the portable computing device, a

10 user instruction based on a respective nlodule of the one ormore modules: receiving an input with the portable com-putin device in response to the instntction, and outputtinto a third party health rcscarcher llm Input associated withthe instruction ol'hc onc or more modules for use in health

ss research rclalulg lo Ihc study. In some cmbodunents, Ihesystem is configured to de-identify the user input from theuser before outputting to the third party health researcher

US 11,107,578 B2i

Thc system and associnted modules may ibnhcr bc config-ured accordin to any of the aspects and embodimentsdescnbcd lu:rein.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a simplilicd block dia riun illustrating a systemfi&r facilitating research in accordance with certain embndi-ments of the present invention.

Fl(i 2A is a sinlplified block diagram illustrating anexample system architecture for facilitatii&g health researchds described hcrcin. In accordance with ccrtaui embodi-nlcltts,

FIG. 2B is a simplilicd blocl diaeyimi illustrating anexample systenl architecture for facilitating health researchds described hcrcin. In accordance with ccrtaui embodi-nlents

FIG. 3 is a sequence diagram illustrating various systemfeatures to facilitate research a third-party researcher and aresearch participant using a portable device of the partici-pant. Ul dccorddnci: with ccrldhl i:Iubodhui:Ills.

FIG. 4 is a schematic of the process by wlfich a moduleulcorpoliucxl hlto dn Bppllciilloil ildnli:wolk v,uhul II por-table device of the reseamh participant. in accordance v ithcirlain cmbodimcnts.

11(ig 5A-5N are exmnple screens displayed on the por-table device of the research participant that pertain todifi'ering types ofmodules acconunodated by the applicationframelvork. in accordance with certain embodiments.

FIG. 6A-60 arc cxmnplc scrccns displayed On lhe por-table de&ice of the research participmit that pertam to aspecialized consent nlodule accommodated by the applica-tion framework, in accordance with certain embodiments.

FI(i 7A-7('re exanlple screens pertaining to additionalexamples of survey modules acconmtodated within theapplication fmsmework, in accordance with certain embodi-IIICIuS.

FIG. 8A-8F arc example screens pcrlaming lo an activitytask module accommodated within the application frame-work. in accordance with certain embodiments

11(i 9A-9(i are exaiuple screens pertaining, Io an activitytask module acconuuo&iksted within the application frame-work, in accordance v ith certain embodiments.

FIG. 10A-10E arc cxamplc screens pcrlaming lo anacus ity task module acconunodaled within lhe applicationfranlework. in accordance with certain embodiments

FI(i 11A-IH're example screens pertaining, to an activ-ity task module acconlmodated within the application frame-lvork. in accordance with certain embodiments.

FI(h 12A-121 are example screens pertaining to an activ-ity task module ucconmiodatcd within thc applmation frame-

workk

in accordance with certain embodiments.11(ig 13-14 are flowcharts of methods of facilitating

treatment using modules within an application fmsmework ofa portable conlputmg device of a user, in accordance v ithcertain embodiments.

Dill'Ail liD Dli)('RIPI'ION Ol'I'111'.I Nlyl INTION

In the folloiving description, various examples will bedescnbcd. For purposes 01'xplanafion, specific coniigura-uons and details are set I'orth in order lo provnle a thoroughunderslandulg oi'he examples. However. It will also beapparent to one skilled in the art that the examples may bepracticed without the specific details. Iiurthernx&re. well-

known Postures may bc omiiled or sunplifiixl so as nol loobscure the example bein described

1imbodiments of the present disclosure provide improvedmethods and systems for facilitating health research byimproved comnuuucation between researchers and researchparticipants tluough an application framework on a portablecomputing dcvicc of Ihe participant. Iu ouc aspect, IhcdpphcB11011 fliinlcw'ork dcconunodatcs vdrloUs ihilcnngtypes of modules that can be selectively used as needed fi&r

IU a particular research study to present and/or obtain healthinformation to or fmm the research participant In oneaspect, the application framework ls developed by a first-party and may include one or more modules developed bythc Iirst-party that can be utilized by a llurd-party rcsearchcrto prcscnt and/or oblmn health ini'onnauon from the pariici-pant as desired In mlother aspect. the application frameworkaccmnmodates modules developed by a third-party. such asa researcher conducting the study, so that the presentation ofinformation to the research participant can be customized

zo according to the researcher's needs.In onc aspect, thc application 1)amcwork is configured lo

uuhzc health inl'ormation accessible by the portable com-puting device (eg smartphone. tablet) )uch health inti&r-

mation may include health information from the partici-pants electronic medical record (IIMI() accessed thmugh aserver communicatively coupled with the first portabledevice. or health infi&rmation on a database, v hich mayinclude health infonuauon entered by the user or oblantcxfby lhc user (c.g.. persoruil information collcctcd by onc or

so more wearable sensor devices and/or stored in a portableelectronic device of the user) I'his aspect is advantageous asit allows the research to utilize a considerable amount ofinformation that vvould likely be too burdensome to obtainv ith conventional methods. In certain aspects, the system is

&s conilglllud 10 SCgICgdli: hCdllh Iniornlatloll 01 lhi: USCI SIICh

thai thc rcscarchers may only access hcullh information Ilia l

the user has aulhonzed release oi'r hns uilcntionallyincluded in information to be released for research Incertain other aspects, the health information nlay undergo

do de-identification such that the health information may beused for research witlu&ut being associated w ith any particu-lar User. This dspccl Ind)'llow fi&I'clcasc 01 llcdllll uliol-mauon that a user v ould otherwise bc reluctant Ur averse toreleasing for use ui research.

In oile aspect, the system nlay be inlplenlented as acomputing device conti ured lvith a menlory and a proces-sor The processor may be configured to execute instructionsstored on the memory to nm the first-party applicationframework and to rcceivc onc or more modules from a

U tlurd-party rescarchcr in order to prcscnl rcscarch studyhliornld11011 10 a user, rccrilll lhc ptilslclptinl for lhc rcscdlchstudy, obtain informed consent from the participant, as wellas conduct surveys and obtain information regarding varioustasks pertinent to the research study. The first-party appli-

» cation framelvork may also utilize one or more modulesdcvclopcd by Ihc first-party in accordance with ccruiinrcquircmenls sclectcd by the third-purty rcsoirchcr.

Embodiments of Ihc present disclosure arc directed lo.among other things, managing personal information

io received fmm external sources. Or from other periphemsldevices of a user. In some examples, the information col-lected by the data collection devices may be prnvided to auser dcvicc oi'he user (e.g., a mobile phone, a uiblclcomputer. a laptop computer, a wearuble computulg device,

ss ctc ) iinibol linc 01 Ilx&lc first-patt)'r third-ptil1v dppllca-tions of the user device, before being selectively transmittedto a researcher fi&r a treatment In some exmnples. a first-

US 11,107,578 B2

par(y dpphcation may bc onc tha»s provslcd with thcoperating system (0/S) of the user device. is configured tooperate natively with thc user device, provided by thedevelopers ol'hc 0/S for use wi(h the user device. and/ortrusted by the 0/) and/or device A third-party applicationnlay be one that is pmvided by a third-party or entity otherthan the developer/manufacturer of the user device and/orit's 0/S. Examples of Information heing collected and/ormanaged may be health. fitness. and/or activity infomtationof the user (C.g., blood glucose levels, v,cigh(, height,calories burned, hear( rate. ctc.). The user inlhnnanon maybe cateaorized or othenvice identified by one or more datatypes (or cate ories) Weight, nuiliber of steps v alked,nunlber of calories burned, heart mote. etc., are each anexample of such health data. Other data types (e.g.. outsideofhealth infomlation) are also envicioned including, but notlimited (o. hours worked, hourly ra(c, nules per hour, pagesread pcr nunu(c, ctc. A user device of (hc researcher alluw sfor ready selection of a set of data of health inforniationrelevant to treatnlent and/or diagnosis, while the user deviceof the user determines a subcet of the requested data setauthorized by the user to be sent to the recearcher.

In some embodiments. a first-party application frameworkmay bc exccutcd on a user device of (he user that isconfigured (o rimclve, store, malmge, imd/or provide suchuser intilrnlation to a service pnlvider, to third-party appli-cationc, to other first-party applications, and/or to localstomcge of the user device. As part of the first-party frame-work, a first-party process may be executed by processors ofthe user device. The first-party process may include. but isnoi luni(ed Io, a daemon or o(hcr background processconligurcd to conmiunicd(c with (he Unrd-puny applica(iona,the O'S of the user device. and/or electronic storage of theuser device. In conte instances. first-parry pnlcess may beconfiaured to nlanage a data interchange filr sharing someuser data with third-party applicationc as well as theresearcher. In this way. the first-party process may allow thercscdrcher lo access user infonnallon tha( was miliallyprovided by the (bird-par(y apphca(ion. a firsl-parly appli-cation. Or other tlurd-party applications Since health infor-mation of a user may be considered extremely personalandior confidential, the user Ic provided v;ith the ability toprotect or othenvise not share some of the heath infomtationwith the researcher or cenain researchers. In some examples,each (lurd-par(y application may be inslrucled Io rcxlucs(authorizd(ion for accessing panicular (or all) data Ibom thedata interchaime before tmlnsmitting the requested healthinformation to the researcher

I. Sys(mn Overview

FI(i 1 illustratec a simplified diagimn of a health researchfacilitatin cystenl 100 with enhanced exchange of healthinformation, in accordance with embodiments of the presentinvention. The system 100 includes a pormbie electroniccompunng device 102 (e.g. smartphone, tablet, lap(op, com-pUlcl) dssiiclan:4 wllh thc ilscr thloiigh wlllch Ihc uscl or II

caretaker of the user (c.g parent, nurse) can imlia(c aresearch related session with the researcher as v ell accommunicate health information to a first researcher, typi-cally to an electronic user device ascociated with theresearcher (e.g smanphone. tablet). In one aspect. theportable or user dence 102 of the user (ypmally includes a

plurality of health data clcments s(ored on a memory of thedevice or on a user data scrvcr 320 (e.g. scrvcr, cloud)accessible to the first ponable computing device 102. I Iealthinformation of the user is received in the user device 102,

either inpu( by Ihc user or acquired I'rom one or more semordevices, such as a wearable censor device (Ul (e.g censorv etch) nr a specialized auxiliary censor device 1(13 (e gheart monitor patch, li(:(i, blood glucose sensor, etc ) 'lhehealth information is then wirelessly transmitted to a dataserver 320. typically a server associated with an applicationon thc portable computing device 102 that facilita(cd col-lcc(ion of (he hmi lib data (e.g. I v Party scrvcr suppor(uig aI" Party I lealth I )ata Application on the portable computing

In device) In some cases. where the application developer icthe same as the entity supportin general operation of thephone. the device server and the application server may bethe same server.

In this sys(cm, thc ponablc compuung device 102includes an Application Framework conligurcd to interfacev ith the user according to various diffenng modules ln oneaspect, the Application Iiranleivork defines the mamier andform m ivhich the application interfaces with the user, filrexample the manner in which infilnnation is displayed to the

lo user on the user interface of the portable computing device102 as well as (hc manner ui which the user manages the ufo(0 g. scrolls throUgh Ihc sclcclls ol nllolnld11011, advances 10

the next screen, or selects an option displayed on the screen),as well as how the information appears In another aspect,the Application liramework is conhgured to mterface ivithone or more sensor devices 101. 103 conununicativelycoupled with the portable computing device 102, forcxiinlplc, (0 colltlol aspccm of thc iieet hltcrfBcc 111 dccol-dancc 311th ou(pu(s ol Ihc smlsor and/or to moni(or semor

30 data from the nne or more sensors based on a user input soas to allnw the portable device 102 to pertilrm variousfunctions relating to the research study, including but notlimited to: initial conununication of the research study,recnutment of research participants. consent of research

lc par(IClpdn(S, BCqiils111011 Of hCIU(h nllornld(1011 fol USC 111

heal(h research, comnnuncation of Ibllow-up informa(ion,'nquincs

as nccxlcd, and vdnous o(her rcscarch rclatcd tasks.While the Application liramework provides the frame ormeans by which these tasks are acconlpliched using the

do portable computing device. the content and particularrequirements unique to each task are informed by one ormorc module rccelvcd by the device 102.

In this system, the modules may be I"-party Modules 300or 3" -par(y Modules 301. Thc I"-Purty Modules 300 arcdeveloped and provided by the same entity that developedand provided the Application I'rmnework and may be pro-vided along ivith the Application Fmmework or made avail-able through the device server for use on the device asnimded. Thc 3'"-par(y 3 party modules arc dcvclopcd and

c provnlcd by 3" -party cnntics, siwh as a 3'd-party researcher,and include venous con(cnt/elemmits that may bc unique (othe particular research study bein conducted and not readilyavailable through the I"-party modules 3UU In one aspect,the 3rd-partv modules may be developed by the 3'd-party

11 researches using a portable device 402 (e.. tablet, laptop,computer) assocla(cd ictth Ihc researcher. Thc por(abledevice 402 of the rcscarchcr may uicludc an apphcatloncorresponding to Application Framework (hat allows thcresearcher tn enter the requirement content or information

ic v ithin a module cn ac to suitable for use with the ApplicationFramework. The 3'partv modules 301 may be providedand stored on a third-party server 420 that is communica-tively coupled (o the I"-partv scrvcr of (hc Apphca(ionFramework and/or Ihc dcvwe scrvcr I'or ncccss by thc user

sc dcvicc 102. Thc Application Frtuncwork is configured (opmvide the desired tasks based on either or both of theI"-party and 3"-party 3 party modules received In one

US 11,107,578 B210

aspect, the Application Friuncwork mdy utilize both a I"-party arid 3"-party inodnle received to intiirm a siiigleaction or task comniunicated to the user. It is appreciated,however. that a research study could be conducted usingsolely 1*uparty 3'"-party modules 300 or solely 3 partymodules 301 as appropriate for the health study beingconducted.

In another aspect, the I"-party scrvcr 320 is conumuu-catively coupled with or includes a health inforniationdatabase 321 associated with the user '(he health informa-tion database 321 stores or accesses a plurality of healthelements acquired through a Health Data Trackin Applica-tion stored on the user device 102. The plurality of healthdata elements may bc used by various entities such asregula(cd medical servwc providers Ilrdt may utilize thcacquired health information received from the user dataserver and perforni additional health related servi caw such aspmcessin health data to determine trends or various otherhealth metrics. Such processed data is enerally made avail-able to the user device 102 tlirough the user data server 320.

In onc aspect, thc research server 420. Bs well as anyIc9cBrchcl clcciroiiic device 402, Is colIiiiiiiiiicB(ivclycoupled I "-party server 320 which in Birn may be coupledwith the electmnic niedical record (I(MR) 'Ibis aspectalloivs health information from the I(MR to be obtained, asneeded. along with any health information or input from theuser device and de-identified from the user before transmis-sion io thc research scrvcr 420, wluch safcguards pnvacy ofthe user's medical records. Since the user device 102 of thcuser is communicatively coupled to the research server 420through the Application lirarnework. research related ses-sloiis can bc'ofidiictcd miliotcl)'viiltolrt rcquillng thcIIBci'o

visit the clinic and lar e amounts of health infomtationcan be mspidly transmitted while still safe uardiiig userpniacy. Tins approach w advmuagcous over convmitiorialmethods of conducting rcscarch as ii reduces thc burdmi onthc iiscr/Icscarcll pBTIICIpaili to siipplv'liv hcBltli diitildirectly to the researcher In addition, in some studies, tlusalloivs the user to be recniited and emolled without anyin-person contact or periodic visits to a research facility,vvhich would likely discoumsge some users (born participat-iiig iii il rcscdrcll study, pdriiciildi lv Iol Iiiosc rcswslcil st tidiesrclalmg lo scnsitivc or conirovcrsml topics.

In one aspect, user dcwces 102 in combuiation with thcone or more sensor devices. in this example, v earabledevice 10( and/or auxihary sensor device 103. allov col-lection and/or analysis of large amounts of health data foruse in niedical research in amounts far greater amounts thancomentional research techniques could reasonably attain.Dcaluig with such large ammuiis of dais, however. maynegate any associated banc(its such information provides asit nmy prove difiicult and overly time consuming, to nianageusing conventional methods of data collection in healthresearch. In one aspect. the Application Frmneivork is con-fi ured to output only health data infomiation that is autho-nzol for disclosure to the rcscarchcrs. Typically, whenaccessing lmdlth informanon obtauied ouisxlc ol'hc Appli-cauon Franu:work, such as I'rom Ihc health mfiimiationdatabase 321 or I(MR. the permissions and authorizationsare determined and/or set by the user in the other applica-tions associated with collection or access of that healrh data.

In some embodiments, health infomiation may be inputdirectly uito the user device 102 by (he user or may beob(anux( tluough onc or morc health uiformaiion acquisitiondevices or sensors. such as wcarablc device 101 (c.g. watch,wristband) that the user wears such that one or more sensorsof the wearable device measure one or more parameters that

can bc used Io deicnnine health dais, either directly orindirectly Iior example. the v earable device 101 may mea-sure body temperature directly or may measure activitylevels by use of one or niore accelerators In some embodi-ments. the wearable device 101 is incorporated within thefirst-party framework of the user device 102 The one ormore sensor devices nuiy bc specialized for sensing and/ormcasufing venous health meuics, including but not Iimiicx(to activity level, activity tracking, respiration, body tem-

Io perature, heart ivellness data. hydration level~. perspinstion,blood glucose. salinity, sleep cycles. posture, Oc levels,muscle engagement, or any combination thereof. The col-lected data may or may not be specific to the condition beinganalyzed in the study and may bc collected without rcquinngany iuldit iona 1 inpu I from thc user Io uiiiui Ie collection of Ibcsensed data. In sonic enibodiments. the sensed data iscollected over a duration of tinie, the duration generallyexceedmg a few days. such one or niore week~. months oryears. Typicaily, these mixiliary health sensor devices 103

Io are tlurd-party devices that are supported by a third-partyapplication and managed by ustx( of a durd-pany serviceprovulcr 300. Such sensors 103 may also bc a regula(Ox(medical device that is supported through a regulated medicalservice pmvider 30( 'I'he user device 102 conimunicates thehealth information to the user data server 320, which may beselectively accessed by the researcher data system based onidentification of a subset of data authorized by the user to bereleased by Ihc researcher.

Flfi 2A illustrates d sunph(icd arcluicciure diagmm100'cdepicting a user device IU2 confi ured to implement afirst-party I lealth l)ata I'racking Application 104 that man-ages exchange of health intbrniation received by the userdevice 102. The first-party application 104 may be confi-ured as an application framework for managing user data of

Is d pliiralil)'l ckiid collcclioii devices Iii soiiic cxiiiiiplcs,bimausc thc lira(-party application manager 104 is provides(or othcrwisc controlled by developers of thc user dcvicc 102and/or its associated 0,'S. the first-party application manager104 may be considered a trusted framework with full access

do to all user data. The Research Application Framev orl 350 isyet another framevvork stored on the user device 102 thatmiuiagcs thc health inlonnaiion obtained through cfii:ctuigthc rcscarch modules (c.g. the 3" -party modules 301rcccivcd from thc research server 420. In onc aspcck wlulcthe manager IU4 (also known as the fnsmework for I Iealthl)ata I'racking) niay only alloiv a portion of its health datato be shared within the Research Application framework, ingeneral. any sensor data of health information obtainedtluough thc Research Apphcation Framework is automdii-

o cally uploixlcd io the Health Data Trdckuig 104.In some cxamplcs, ihc lira(-party process 106 may be

cmifigured to manage (e.a, store, retrieve, encr)TII, etc.) userdata via a database 109 of the user device 102 As part of thefirst-party application manager 104, the database 109 may

ss be divided or otherwise logically sepamted into a plurality ofclasses of dais stores. For cxamplc, thc user data may bcstored iii 9( least otic ii( d clil99 A ilatil store 110, a clBss Bdais store 112. a class C dais store 114, and/or a class D datastore. In soine examples, the class A data store (10 may be

ic configured to store personally identihable user information(e g., personal health. fitness. or activity data) In someexamples, this data is only available to the third-partyapplication 108 when the user device 102 is un(ockcx(. Byway of example, thc user device 102 may bc unlockcx( when

Ss tiic iiscl associated v'lilt Ilic ii9cl ih:vlcc 102 llas colrccilventered his or her user identifier (ID) and password (e.g,when logging in andior unlocking the lock screen) ( lass B

US 11,107,378 B212

dain store 112 may bc conligurml to store '*Iounril" typedata .Iournal data niay include, but is not liinited to. per-sonally identifiable user information and/or other nietricsassociated ivith use of one or more data collection devicesand/or the third-party application 108. When the user device102 is locked. the journal data of the class B data store 112may bc uiacccssible to thc tlurd-pdny application 108.However. in some cxamplcs, data foun a da1a collectiondevice or an application (e g, the third-party application108) may be read fmm or written to the class B data store112 by the first-party process 106 while the device is lockedas long as the first-party process 106 is active. If. hosvever,the first-party process 106 fails or otherwise becomes inse-

nsee

ui the process ol'caduig or wntuig data to the class Bdata store 112. thc data may bimomc permanently macces-sible. and new data ntay not be written to the class II datastore 112 until the first-party process 106 and,'or a nevsession of the third-party application 108 have relaunched.In tins stay„ the data of the class B data store remainssecurely accessible because it is only accessible to thelirst-party process 106 while rccciving data lbom a tlurd-party application 108 during thc active session, mid no otherapplications can read that data.

In some aspects. the class ('ata store 114 may beconfiaured to store metadata associated with the manage-ment of the user health. fitness, and/or activity data. Tlusmetadata, in some cases, may only be accessible after theIirst unlock ol'hc user device 102. As such, if the user device102 rcboots (based at least ui part on a sol'tware issue or aloss of battery power), this data may not be available untilthe user unlocks at least once In some aspects, this mayprevent jailbreaking or other hacking techniques frontaccessing this data. Tire metadata stored in the cLsss C datastore 114 may include subscription information. accesspernnssion udonnation, and/or safi: mctddaIa, but may not,in some cxamplcs, identify or be dirimtly associated with anyhealth uflhmiatiou (c.g., the data sturcd m the class A datastore 110). I he class D data store 116 may be contigured tostore free-form (e.g, unstructured) information pnivided bythe user. In some examples. this may be health data; how-ever, it may not be updatable and/or linked to any third-partydpphcauons (e.g.. the tlurd-party apphcation 108) or datacollection devices. Thc class D data may alwavs bc availableto thc Iirst-party process 106 and/or the tlnrd-party applica-tion 108. In some aspects, the class I) data may be pre-filledusing intiirniation fmm the third-party application 108 and/or one or more other applications or processes. However, theuser may be able to enter additional data. update the data,include incorrect data, or otherwisc configure rite inlhmia-uon ui thc class D data store 116 as they sim Iit. The class Ddata may bc available on thc lock screen ol'hc user deviceI (IZ ivithout anyone (e 8, the user) logging in or otherwiseunlocking the user device 102 In this way, the lock screenor another accessible screen of the user device 102 may beanalogous to a medical ID bracelet. In some cases. Bn

muergcncy icon or other funcuon on thc luck screen maymiablc thc presentation or rcndcring of the class D data uponrixpica 1 Ihr anyone (c.g., mi emergency medical tcclmician orthe like) to see Iiurther, in some aspects„ the third-partyapplication 108 may not have access to the class D data. inpart because it may be unstructured data that would bedlfftcult for the third-party application 108 to process

In one aspect, thc Iirst-party process 106 idcntilies hcal1hinl'onnation data authonzcd by thc user to bc sent to theresearcher as Authonzcd Data 150. Such mi idcntilicationniay be based on a default, a pre-selection or a live inputfmm the user In response to a query. I'ypically. the most

conunon types of uiformauon beuig requested and idmitfliodas Authorized l)ata ivould be ('ass A and ('ass 13 types ofinforniation Some embodiments may include release ofvarious other t)pes of data, for example to allow furtherprocessing of collected data by an application on theresearcher device. Wlfiie Autlmrized Data 150 is shownsclicilldtlcdllv's B scpdratc ch:iiicilt, lt ls Bpplccli11cd tlnllsuch mithorizcd data is not rcquircxl to bc stores) In a scparaielocation, nor is it required to be identified before the request

Ia for information is made. 1his may instead be accomplishedin various different ivays, for example, by tagging or usinga specific identifier for each fiel of data to denote wlfichdata items are authorized for release by the user and to whichparties thc data is authorizixl for release. Iu some mubodi-mcnts. thc ulcntilicauon ol'ithonzcd data is dcternunodonly after receiving a request for data In systems havingexceedmgly large amounts of health information data thisapproach inay be more eflicient. since the data is onlyanalyzed to detemiine mithorization of the (L)ta set that is

zo being requested.As shown in FI( L 2A, conunumcdtiou of data bc(ween the

user device 102 and the rescarchcr device 302 may befacilitated by use of an application conimon to both devices,such as the Researcher (:onnect Application 350. 331 pro-vided on the user device 102 and the researcher device 402,respectiveiy. such as shown in System 100'f FICi 2, In thisaspect, the devices may conununication through a commonserver (c.g. physical scrvcr or cloud) flrdt supports thcconunon apphcation. as opposed to gouig through scparatc

so but interconnected server inforntation 'I'he researcherdevice may separately couple ivith the researcher server 420as well as the I ilvIR to import additional information externalto the health information data associated with the mobileuser device 10Z. Wlfile the application may be conunon to

is both dcviccs, gcncrally. the applicauon would uicludc li:d-tUres sUltcd lor tlic piirllcUhli Uses Bssociiltcd ss i(It Melldcvicc For example, thc application may display heal(Itinformation data niore succinctly on the user device, than onthe researcher device In addition. the application of the user

do device requires a feature that allov, s the user to select dataauthorizations. while the researcher device applicationrcqillrcs II IcalUic 111BI allows tire rcscarclicr to select scm oldata to be requested.

In some cmbodmients, tlus applicdtiou is a lirst-partyapplication on each of the devices and may be incorporatedpartly or fully into the first-party framework Iior example,the application may run in the background durin normaloperation of either device. so as to be readily responsive tod collllltillllCiltloii Ihilli cltliCr dCSICC Uslllg tllC iippllCdtloii.

o By using a Iirst-party application or platlonn for facilitatuigsession iuitiauon imd conunumcatiou regarihng rcscarcherhealth mformation request and release of authonzed data bythe user, the systeni alloivs a central location from which theuser can manage and authorize release of (Lsta that may be

s. provided by various different sources (e.g. third-parry appli-cauou, third-party scrvcrs). While these dilfi:rent sourcesand 1lurd-party applications/scrvcrs may each include theirowu pemussion and authorizations regarding storageandtransniittal of secme health information data, muting the

io transfer of data thnui h the tirst-party application ensuresthat the user is avvare exactly what data is being released andallows the user an opportunity to chan e mithonzations ofdata and rclcasc data. regardless of pcrmtsstous assocmiedwith the third-party application or other data source.

ss FICi 2B illus(ra(ca miother example system 800 using d

user device 102 and associated health information collectionscheme in accordance with the present invention. III(i 213

13US 11,107,578 B2

14dcpicxs a user dev&cc 102, thc Iirsl-party application frame-&1 ork 104 for health data tracking. and the first-party process106 ol'FIG. 2A. In some examples, one or morc llurd partyapplications (e g, th&rd-party source application 802 and/orthird-party application 804) may be u& conunumcat&on withthe first-parry application n&anager 104 and/or the first-partyprocess 106 for pmviding user information collected by ahealth data cnllection device 101 In so&ne examples. thedata collect&on device 103 may be any wearable or special-izrxl user dei &cc configured lo collect dct&vny. hcald&. med&-

cal. Bnd/or fitness information about a user. This infomtntionu&dv lieu bc provuh:il to Ouc ol lhc lhud-parlv apphcanous(e a., the third-party source application 303 in thi ~ example)1 &a onc or more networks. Once received by the tlurd-partysource application 303. the infornmtion can be pmvided tothe first-party pmcess 106 for storage in the database 109

As noted above. the user device 102 may be configured tomanage a ILItn interchange for reading and/or w:ritin userdata to lhc database 109, and for sharing d&at user dataantong one or more authorized third-party applications. Insome examples, thc data collection dcvwe 302 may beconfiaured to provide health. fitness, activity„antgor medicaldata of the user to a third- or first-party application (orpmcess) In turn, this data maybe shared, aggregated, and/oraccessed via the first-party Health Data Tmcking manager104 that may be configured to implement the first-partyHealth Data Trdcloug manage 104. The user dcv&cc 102 maybc any type of computu&g dev&cc such as, but nol lmutcsl lo,a mobile phone, a smanphone, a personal digital assistant(Pl)A), a personal computer (e g., Lsptop or desksop), athin-client device, a tablet computer. an electn)nic book(e-book) reader. a weamble device. etc. In some examples,the user device 102 may be in communication with thescrvicc pro& ider computers 304 and/Or lhc dale collect&ondevice v&d lht: nclworks shown ol via other uctwo&k con-uccl ious.

In one illustrat&ve configunstion. the user device 102 mayinclude at least one n&emory and one or nx&re processingunits (or processor(s)). The processor(s) may be unple-mented as appropriate in hardware, sofiware (e.g.. com-puter-executable &nslrucl&ons, Iirmware. elc.). or combuuwnous lhcrcof. Computer-cxccutablc instruct&on or iinnwarcImplcuu:utat&ous ol lhc proccssol(s) u&av u&chxh: ulachulc-executable instructions wntten in any suitable programntinglanguage to perform the venous hmctions describtxf 'I heuser device 102 may also include geo-location devices (e g.,a global positionin system (OPS) device or the like) forpro vidu&g m&d/or rix ordu&g geograpluc local ion mfi&nnal&onassociated w&th thc user device 102. Thc memory may storeprogram instrucnous liat arc loadablc and executable on thepmcessor(s), as well as data genensted during the executionof these progrmns Depending on the configuration and typeof user device 102. the memory may be volatile (erandom access memory (RAM)) and/or non-volatile (eread-only mmnory (ROM), fiash memory, elc.). 11&c userdcvicc 102 may ulso include add&uunal rcmovablc storagednd/or non-removuble storage including. bul not hmiled lo,magnetic stonsge, optical d&sks, etc. The disk drives and theirassociated non-transitory computer-readable media mayprovide non-volat&le stomge of computer-readable instruc-tions. progmsm modules. data stnictures, and other data forthc computing dev&ccs. Iu some implemcnlanons, thememory may include muh&pic d&ill:rent types of mmnory,such as RAM, stat&c rm&dom access memory (SRAM),dynamic random access memory (DRAM), or ROM Alt&lethe volatile n&emory descnbed herein &nay be referred to as

RAM, any vulat&le memory (c.g, that does uot maintau& datastored therein nnce unpin ed fmm a host and/or power)v ould be appmpriate

Additional t)T&es of computer storage n&edia that may bepresent in the user device 102 may include. but are notlim&ted to. phase-change RAM (PRAM). SRAM, electri-cally erasablc progrnnunable road-only memory (EE-PROM), fiash memory, compact d&sc read-only memury(('l)-ROM), digital video disc (D&2D). magnetic cassettes or

in tape, magnetic disk storage. or any other medium that can beused to store the desired inforn&ation and that can beaccessed by the user device 102. Combinat&ons of any of theabove should also be included within the scope of non-transilury computer-readable nuxlta. Altcmalivcly, com-

I puler-rcadablc conunu&ucai&on mcd&a may utclude com-puter-readable instructions. pmgram n&odules, or other datatransn&itted within a data signal, such as a carrier wave, orother tnsnsmission. Iio&vever, as used herein, computer-reatLIble storage media does not include computer-readable

10 conununication media. The user device 102 may also con-(au& couuuun&cattous connect&in&(s) liat Bllow lhc Use&

dcvicc 102 lo conununicale w&th u duta store (c.g., lhedatabase 109). or another computing device via one or morenetwnrks the user device 102 may also include I/Odevice(s), such as a keyboard. a mouse. a pen, a voice inputdevice. a touch input device, a d&splay. speakers. etc.

Turning to the contents of the memory in more detail, theulcuiury uldv &uclUdc du t1pc&dfing s)'steal Budiol ouc olulorc ilppl&caltou p&ogrdu&s or st:&vices Io&'n&pica&cuing lhc

&0 features disclosed herein 'I he back mund module 336 &nay

be configured to launch and/or relaunch third-party appli-cat&ons m as background process In some examples, thebackground module 336 may also be configured to verifythat the tlfird-party application has finished processing the

Is dale &I rixpicsled, by coniinuing lo reluunch lhc llurd-partydpphcB&&ou ul lhc bBckgroUud uu&11 no&if&cdnon B rccc'ives!thai lhc lhird-party apphcalion has completed proccssu&g.An extension module may be configured to handle register-ing new data types ivith tbe first-party fran&cwork module in

do order to extend the functionality of the first-party applicationmanager 104 of the systems sho&vn in FlfiS. 2A-2LL Further,thc aggregation module mdy bc configured lo aggregate orothcs w &se combine (and. u& some examples, prov&dc prescn-tat&on for) user dale received from mult&pie dilli:rent datasources. The se&vice provider con&puters n&ay also be anytype nf cnmputing device such as, but not limited to, amobile phone. a smartphone„n PDA„B personal computer,a thin-client device, a tablet computer. an e-book reader, awcarablc dev&cc, elc. In some cxamplcs, thc serv&cc provider

0 computers 304 may bc u& commutucat&on with thc userdcvicc 102 and/Or the dale collection dcv&cc 302 via one ornx&re netv orks or via other net&vnrk connect&ons

l&I(i 3 illustnstes an example sequence diagram describ-ing features of the research facilitating system during simu-

11 lated research conducted in accordance v ith the Invention.In onc aspect, the rcscarchcr and user/research perl&c&paul'sconunu&ucat&on is facilitated by thc 2"'arty apphcat&onframework on the user device and oue or morc modules.such as the 3

"d party modules fn&m the researcher I&irst, thein researcher provides information descnbing the research

study for purposes of recruiting pnrtic&pants by sending aRecnutment Module. Alternatively, such infonnat&on couldbc accessed by thc user de&&cc tluough thc Apphcal&onFramework Ibum a database. Tlu: research study can be

ss prcsculed to lhc user on a graphical user u&tcrl'acc displayscreen as an advert based on nne or more attributes of theuser (or based on health information data of the user stored

US 11,107,578 B2li

on the user device), or the study can bc presented to the userin response to a user input request ii&r a list of researchstuifies available. In response to a user mput mdicstinginterest in participating m a research study, if formal writteninform(Sf consent m rcqu&red, thc research send a ConsmttModule ivith the inforntation/steps/criteria needed to obtaininformed consent. If certain criteria for consent are not met(e . failure of comprehension test or response indicatinglack of engagement). the consent process is ended. If thercxfutrcmmtm lor utlonned consent urc met. then typically a

consent form is displayed to the user and a si naturerixp&est(Sf. an image ol wluch ts then output to the rcscarcherfor purposed of record keeping Once informed consent isobtautmf, the rcscurchcr may scud mty number of 3sd partymodules and/or select certain pre-defined I" party modulesto elicit infomtation from the user for the research sntdy. Then&odules may be

configured

t provide instruction to the userin the foun of information surveys l&aving one or morequcsuons, or activ&t&cs and tasks that may use sensor dataduring perfi&rmance of the activity or task to verifi& and/oratmfyze ccrtaut parameters relevant to the research study.Once the input is obtained from the user, in the form of userinput (c.g. sclcction, entry ol text or numeric) or ut thc fi&nn

of input received from one or more sensor devices mtcgratedwith or external to the user device, the results are then sentback to the third-parry researcher ln many such studies. thehealth information relating to performance of the modulesundergoes de-identification so as to safeguard the privacy ofthe user.

In the scxfucncc schematic shown in thc example of FIG.4, thc Application Framework is used w&fit both I

u party and3" party n&odules to recmit a user in a heart disease study.l&irst, the Application l&remen:ork receives a study selectioninput front the user selecting the heart disease study Inresponse. the researcher sends a third-party module (Con-sent Module IB) to the Application Framework. The Con-smtt module may utclude &nl'onnat&on specific to thc studybeing undertaken mtd may further select onc or morc I"-party modules to be used durutg the consent process. such asSurvey Module IA Age and Survey Module li3 Medica-tion I [is(Cry. '1'hese surveys are pre-defined surveys havingone or more questions that may be used Bs needed by thethird-party. Afier consent ic obtained and the participant issuccessfully enrolled in thc health su&dy, onc or moreadditional modules arc sent and&or alen((fied to elicit healthinformation relating to the study fmin the user. such asSurvey Module 2I3 ileart Disease ()uestfonnafre, TaskModule 3B Baseline Iieart Rate Monitor and ActivityModule 4B Fast Welkin v ith Heart Rate Monitor. Each ofthese tluee ntodules are developed by the 3'any accordingto requirement unique to the&r part&euler study. Each of TaskModule3B and Acuvity Module 4B includes monitonn ofsensor data to measure a paranteter (e g heart rate, walkingspeed) for use in researching heart disease

II. Exmnplc Module Types

In order to further illustrate the dftferent types of modules,reference is made to l&1([S 5A-5N. which depict screendispLays pertainin to the difierent types of modules for usewith the Application Framework described above. The dif-lf:rmtt types of modules utcludcs but are not limited toSurveys, Instrucuon Step, Infonncxf Consent. Acuvc Tasksand Pusan c Data Collection. Thc usc of each of these!&pcsof modules ivithin an example Application 1&ramework isdescribed in further detail below:

&O

ICKSI t mt tu i mS& p = fft(K[ .Bu tu '.Si p.iln CV'htdenidfe&!P" nt& duct on"f.nt&ndu i nnctep t tie = S&,"Basetu&e Survey",

RKSt p *bnnleanStep = f[RKQuest m&Step a[focin i&V ihtdeni tie& Cci&*'bmel ne met cat on" f.

bo te&uatcp t&tlc = 'iv"D you take:&ny d&abe&cs med&uu&ons'& *,

bontcn&S&q& ans c&Founat = [RKBnntca&nknswc&Fon»at nc I,bo te&uatcp opt& net= SO.RKO&dcmdT&sk 'tasl = [[RKO&dcredTask a[foci

utw&thtt u& ti &iu;"b;a b &, k'*a& p. (sf umh*& si t&,

iotaslqff,

To present tins task. the developer hands it

ofi'KTBSLX"tcwControfferfor prcsentauonda

l(K'I. k( Ooru am "& *= if l(K'l.ckv& ('u uutw&th I. &k I. &k u akltu t&t tl& [I 'St ( I & & t&t&ID

f 1,

f. Itp . nlv O m am& am &.tdvhs &pie& m

The resuiting presentation for these steps loof s mayproduce display screens on the user device similar to thosein FIGS. 5A-5B. Additional examples of scrccns corre-

o spondtng to Survey Modules are illustrates tn FIG. 7A-7C.In onc aspect, thc survey module is unplemcntixf by use

of the task view controller of the portable computing deviceBi&el thc specific It lust,'litt&;&tea 111 oi'clat'o prese(it thc stepsFor exampie:

the task view controller implements Ul state rectomstion sotlltlt tt ls et&su Iol dll apphctltloil cicvclopct to ripply'tateresqordtion to its hierarchy.

thc task vww controller keeps track of what penn&ssionswill be needed in order to complete the task, andrequests them appropriately after the instructions. butbefore the results gathering be ins. Tlfis ib done bymaking calls out to a health information databaseaccessible by thc portable device (typically utcludutgpaSS&vclv collCC[Cd lli altll lit[or&lid[toil llolll elle Ol

si morc wearable device), and otlmr pubic apphcat&onprograin interfaces to request permission to access therequired resources If the user denies access the task

so

16A. Survey Modules

To use the survey ntodule in Application Fmmework. onelirst utstantiatcs B model oblcct lucrarchy dcscributg tlm sctof questions to be asked '1 he top level object in thishierarchy implements the RKTask protocol Each log&calpiece of thc task &s a step (a subclass of RKS(cp) Tasks urcprcsentcd using RKTaskt&qtc»Controller, which utlhrms itsdelegate v;hen results are produced When the user com-pletes a task, the survey results appear on the result property

'" of the task vie&v controller. The root task result has a stepresult for each step the user completed, and these may in turnhave subsnltary results. For certain types ol'isks, wherelarge Bllloullm of 4;Ita ale ploducixf. [[lc cfah'I illa&'c stolen!on disk and the result object may simply provnle a rcfhrcnceto that file. TI&ese results can be linked hack to the step thatpmduced them via the identifier. livery result records anidentifier. the start and end timestamp for the collection ofthe result. and any data collected by the step When adcvclopcr necxfs to make a Disk dynamic rather than lustnuming tluough a predefined s&xfucnce, they cdn nuplemcntthc RKTask protocol thcmsclves.

In an example, using f&KOrdere(flask, a built-in imple-mentation of f&KTBsk. (he developer might c&cate a sequen-tial task consisting of a series of questions This would

-'' instantiate a survey &vith a single boolean question:

17US 11,107,578 B2

18may still conunuc &f il possible lo oblmn some valuefron& doin so: otherwise an error may be returned tothe devclopcr to &ndmdte thc task should be cancellcxk

the task view controller keeps track of the results ofquestion and form steps, so that &f lhc user navigalesback through a question. their answers are still avail-able as defaults when they navigate forward again

I Instn&ction StepAn instruction step can be used to gii e instructions, or to

h&lroducc n task or a ui:w seel&on ol &i Risk, when thcic ls noneed to obtain a spec&fic result An instruction step can havedn &dent&lier. titles &cxt, deta&[Tex&s and mdy lmve m& unagc.An instruction step produces a simple RKResult v ith noclukirm&, to ind&cd&c &hat thc user sdw the instnict&on. Anexample of such an instn&ction step is shov n in FKi 5G,tvhich indicates to a user that the Fitness Test Module willbe performed.2. Question Step

A quesnon step can bc used lo prcsmil a su&gle questionat a tin&e or nuiltiple questions according to particularscqu mice. A question step lms Bn &dm&lflicr, text. l illa, answerfiirmat, and a placebo[der In addition, questiica steps can bemar[ed opnonal &I lhe user can choose nol lo answer a

question. I'he ansiver format describes the parameters of thequesuon and how «should be asked. Mm&y ol'he answerfiirmats support defmdt values Supported ansiver formatsinclude: a scale answer format. wlfich presents a shderwhich lhe user can use to select values on a scale (see I(I(i.5D); a Boolean answer format. (e.. "Yes" or "No") (seeFIG. 5E), a tpaluc picker answer fornax. Prcscnts a scl of textclmices using a UIP&ckerK"&ew (e.g. spinni&tg wheel)(seeFIG. 5F). an &mage choice answer forms(s winch presents animage scale. where the developer supplies the images on thescale and appropnatc labels Ibr each, a text choice answerformat that presents a list of options in a table format for usein either multiple or single choice, which is particularlyusehil where details are needed to qualify the choices (seeFIGS. 5G-5H), numenc answer format in either decimal orint cger;mswerb, the range ofwluch can optionally be Inn&ted

by application of a unit. minimum, or maximum: time ofdayanswer formac wluch can usc a UIDmeP&cker to lcl the usersclcct a ume ol'day (sce FIG. 51) or d time and date (FIG.5 I): a time interval answer format that uses a UIDatepickerto let the user select a tin&e interval (see I(l(i. 5K); and a textanswer format. such as a free-form text entry, which may belimited to a certain length of number of characters (seeFIGS. 5L-5M)s the lm&gth of wluch can be hm«ed

In one aspccc where certmn quesiions dre askmg for datathai ihe user may have already enlerml into another Hcallhl)ata 'I'racking Apphcat&on on the user device, facility &s

pmvided to use an answer format of a characteristic orquantity type. When an answer fomiat conunon to theHealth Data Traclong Application is used. the presentationdcimls can bc populated aulomancally. and lhc delaul! valuemay be loolcd up Ibom the health information databasedssocia&ed with thc Health Data Tracking Application, oncethe user has granted permission for the Application I(rame-work to read those value3. Form Step

In one aspect, a form step is similar to a question step ina Survey Module, bu& n Ibrm stc)& suppor&s lmving multiplequesuons on a single page. Each ques(ion &s represented byan RKFonnltem, which has an answer fomuit (Iusl hkc aquestion step) A form supports all the same ansv er formatsas question steps is shown in the exa&nple of l(Ki 5N

B. Inforn&cx[ ConsentWhen researchers conduct studies involving human sub-

jects, they arc typically rcquircd to acquirc approval for lhcirstudy design fmm an ethics comnuttee or, in the US,insntut&onal rcvicw board (IRB). For some stu&hes, thc IRBwill require informed consent, that &s, that the researchermust ensure that each participant is fully informed about thenature of the study, and obtain si~ed consent to participateSome studies ivhich are deemed of low risk may have this

1& 1

requircmcnl waived, bul even u& the& cusc it may bc usefulto oKer the information anyway.

Thc Applicauon Framework u&cludes code to provide a

user interface tioiv for informed consent, to present therescarchcr*s inlbrmcd consent document, nnd &o obtain theirname and optionally a scribbled signature to indicate theirconsent. Application Framework can also optionally gener-ate a PDI& record of the consent. where that is useful for theresearchers* workfloiv.

Usc of any part of tins infonncd co&ment suppo&t isoptional: no actual content is included (it must come fromlhc rcscuirchcr s own &ufonuixl consent docunlcnl), Bnd nodigital signature facilities are included qhat is, if the sig;nature ncmds to be vcmliablc and &rrevocablc, then thcdeveloper is responsible for producing a digital signature onthe result or gcncrulcd PDF which can uncs& to the &dent«yof lhc participant and lhc lime at which lhcy signed. Usuallythe rcscarchertdevclopcr would need to hnvc thc parnc&panlm&thenticate to a server and enerate the digital signature onthat server

In one example. the developer nnist first generate a modelof the consent document:

i&K( se &&1 m ni" * . ni = [IRK('ms i&i *umeni . aI i &I,

onsent t tie = 'n', 'Dern Consent".on nt s gnshuePsgeT &le = tn'C nsentxonsent s gnshuePs eC ntent = 'st I.i iee to piit c pate ui &&us

iesem b Shid, ".

RKCoiiscntS&gnstutc "pmicipnntSie = IRKCnnscntS&gustutc

so sieiishucF (PctsonwitbT&tle fitn'Psmctgsttt'stcFnuiiststung iulident&pic( Iti"putimpsntSig'.

[c nscnt sddS&gnstiuc pmti ipsntsigi,i&K( se &Sipnm « "in si g i:i s = [1&K('eu&Spn t

sig sim lotp ts nwibi il lie*in si g t

le i ri t vtictn miss& tire fnstvmi '*i e *I stvu (ni'('&erne n*

s gnstu cans e [1.&ines e rnsgebsmed 'tp's enshue pug"IditeS&nng!p'9( iv'.

[ nsent addS comus uivest stnin I

Nab&un&bien&is& 'omp nents = I.JSS&utsb&eA&tny neel.VSA(is\" sccncs =i!i,[ti(RKCnnscn&ScctionTvpco cine

u'iRKCnnscntScctioeTvpcDstsostlicnn I,c u'(RKCmiscnt SectionT, pcPio set i.

'u!RKCnnsentSect onT, peW tbdniuuig)1,n. for tNSN(unbei* tope n scenes) (

RKConsentSect n* = f[RKConsentSe t n nunc)uut&V tbT, pe t„pe ntege(Viluel,

csiuumst, = in',c litm&Contcut = qi'"'

ompoiicnts iddobic t cii

sa

Then, given that model. one can construct a task contain-ing a visual consent slap dnd a consent review step. That tusk

ss can then bc prescnlcxl using the same tusk view controller aswould be used for a survey ln fact, survey questions can benuxed in v;ith these steps. either to divert users who are not

19US 11,107,578 B2

20dppropnate subtccts for thc siudy w&th some lca(1-in ques-tions, or to include additional infomhation with the consentIcsulm.

1'or exampie, to create a consent task:

RKV suilC nsenrstep *srep = [[RKV suslConseritstep snoc]uut&V thldent fier 'ri, 'v su.il consent" do ument.consent].

RKC onscntRcmc Step *rcmc Step = [[RKC oascntRc ic Stepsll c]!1&ltgltllldorit!ficr 'ri cou5olrt IC IC 'lgrliii111'c Co&15C&lt 5&gllst11&vsgi]

a&Doc&i&&1ollt Cot&so&it'],

RKO»f 1 dl, k *Is 1 = [tl(KO \ dl skrfi *tufivittill I fi ('ms in kll I tl st Ps'u'[ I Pr si«P]l,

And thea pmsent rhe rash.

Once the task completes. the developer can make a PDFfrom thc rcsultuhg document us&ng some&hing lrkc tins

IIK('»0 IS pi t o lt Sufi ~ ga I R 5 II =

(RK('o .'tS g mi R«s It *)f t [I aks 1

('o I

SI pit vuhl !it pl i«ai fi«» 1 Si p I I tl]

lirsig suh],

[domment mnePDI'W thComplet o»Handler (NSData*pdfDat&..ISEnoi *en 1) (

NSL (;1,"Created PDI'f mze 'lu terror = " '0 ln(uns gned longl [pdtDiti lenathi. error).

ll

I Visual ('onsent StepUser device display screens associated with the visual

co&&seal stc'p of cxatllplc coflsclli hunch&les Brc shown ulF]GS. 6A-61. The visual consent step tales B consentdocument (as outlined be]ow ] and presents it Bs a series ofscrcciis wrlh Bu&BIBlcil IIBBS«tons. Tlhc ail&IIIBI&ons drc pro-v hdcd as perl o[ Ihc Application Framework, aiong wi!h the«iles o['he sect&one. However, none of thc contents areincluded v ith the kit: it is the responsibility of the developerto populate the consent document as appropriate for theirstudy. In addition, custom consent document sections can beadded by the developer with their own descriptive inmgesdnd content. Typ&cally, llm ruumauons arc v&deos which arcsupplied as part o['he Appl&cauon Framework package anddhspiayrx[ using publrc apphcdt&on pmgram interfaces2 ('onsenr Review Step

I ixamples of the ivritten consent review step are shov n inF]GS. 6K-60. The consent review step presenrs screens forthe participant to enter their name. review the document. andto scrhbble a signuture on screen. Thc revrew contmht hs

obtauhm[ from a conseni document objcci, ]us& lrkc fi&r the1 hsual conseni step Tlm dcvclopcr can prov&de I[he consentcontent as I ITMI to obtain wlmtever formatting is requiredby their ]RB: the internal implementation uses UIVv'ebViewand/or WKWebView, both public application program inter-faces on iOS.C. Aciive Task Modules

Acduc tasks urc morc uhlcracnvc tasks than surveys,where thc user may be asked to do somethmg I[hat el]owe thcsensors on rhe portable computing device to collect data thatwould be interesting for research.

Many kinds of studies can benefit fbom this type of tasl,whether to actually measure the condition of interest, or todhscover w lml other vena«one uh Ihe env&ronmmhl may aficctthai condition. ThcApplhcduon Frmncwork inciudes severalpre-delincd leaks, bul thc code used Io impiemcnl !hase hs

intended ro be easily extensible This allo&vs the researchcomnnmity to contribute back additional tasks to the

Research Applicdlion Fr;mhew ork to bc made morc w&dclyavailable for research. Typically, the Application Fmsmeworkdocs nol do any analysis o['hc datu collcctcd by a lask.'I'here are as nhmhy ivays to analyze the data as there areresearch projects. Instead, Ihc rcsulung sensor data is gcn-enslly recorded to RKResuit objects in menhory which thedeveloper can serialize as needed. Wihere the data would betoo lar e for in-memory deiivery. it is written to disk in theoutputDirectory specified by the developer, Bnd referenced

111

by an RKF&ieRcsull rclumed whth thc rest of thc task'sresults.

Examples of Acuvc Tasl or Act&v«y Modules include B

Audio or Phonation 'I'est: 1apphng Interval I'est; ([nit andBalance Test: and Fitness Test. Typically, in activity tests themodule includes mh instniction for the user to perform aspecified activity, after which the user device concurrentlymonilors sensor data of onc or more am&sore con[igured Iormeasuring a parameter relating to the instructed activity.

201. Audio Task Module

In thrs task, thc pa«icipmhi is asked to make some kind ofsound with their voice, and the audio data is collected. In oneaspecl, Ibis module can bc usrxl to measure proper&&ca oftheir voice, such as frequency range, or ability to producecertain sounds. Thc underlying implcmcntathon uses pubhcapplication pmgram intertaces «1 AVI oui&dation to collectthis data and present volume indication durin recording. Nodata analysis is done: it is up to the developer to define what

" analysis is appropriate to the task

+ IRKO&deredTssl *ktud Tmk&Vthldent fier ( ISStnng *) dear tie&

ioi« I un 13 1 ipi n ihssi ghs *hntendedL'seDes npt on

sh»lsp *hh 151n .tmn (NSSI» g'ish rtSpeechinsrni t an

durst n (NST meintervsl)durit on

Ice 1'dulgSctt!11 5 (NSDlmtlolmrr00"IrccnrdinnScttmns

pi av iltK&'kfi irl. skopt a)

User device display screens associated with an Audio orPhonathon lest Activity Module are shown m I'l(i) SA-6['he

user is instructed to speak or pmduce certain sounds fora duralion o['ime or R&r as long as they arc able dunng

„v hich an audio sensor, such as a microphone, recordsparmnelcrs of the sound (c.g. uhlensitys p&lchs frcx]uchhcy.

duration] which may be used. for exanhple, to analyzespccch pattcms or vocal symptoms.

2 1'apping 'I'est Moduleo. User device display screens associated with an example

Tapphng Teal lh[odulc arc six&wn in FIGS. 9A-9(i In the twofinger tapping task, the participant is asked to rhythmically,altemativeiy. tap tv'o targets on the touch screen. Forexanhple, data front this task can be used to assess basicmotor capabilities including speed, accuracy. and rhytiun.'I'ouch data, and optionaily accelerometer data from oneoi'ore

accelerometer sensors„are collected using publicdpplrcBI&on prog&drll hnlcrfiiccs. Agdhil, 110 Biullvsg Is pcl-

ss formed on the data; it is up to the developer to determineappropnalc analysis. Tlus lnsk cmh bc uses[ lo obtauh mea-sures related to motor speed and tinhhng

21

US 11,107,578 B222

sz Gait and Balance fShort Walk) Tcs( ModuleUser device dispLay screens associated with this test are

shown ui FICiS 10A-10E In thc short walk task theparticipant is asked to walk a short dis(ance, wluch may beindoors 'typical uses of the data may be to assess stridelength. smoothness. sway, or other aspects of the partici-pant's ivalking by using one or more accelerators sensordevices. The presentation of the short walk difibrs from thefitness check in that distance is replaced by the number ofsteps tdkmi. and thc wnlk is spli( inio d series of'legs Aftereach lcg. ttu: user is naked to turn and reverse direction.

+ (RKOrdcrcdT»k ")shoitiuslkTaskW)tltldcat ficr il SSt»ng s)identi(ieru)tcadcdLscDcscriptina INSStrutp,

numb iop.t psl' p,

(NSInieg ) umhmols)epsPCI. s

pr ns IRKPredehnedTiskopr oalopr oas.

5. Spatial Span Memory Task Module

User device display screens associated with the SpatialSpan Memory task are shoivn in III(iS 12A-121. In thespatial span memory task, the participant is asked to repeat

pattern sequences of increasing length in a arne-like envi-

ronment. In one aspect, the "span*'length of the patternsequence) is automatically varied durin the task, increasingafter successful completion and decreasing after failures. in

) I I the ran e from mininnunSpan to maximumSpan. The speedof scqucncc playback is controllable, and (hc shape of thctap targe( is customizdblc. Thc game finishes when eithermax Tests lasts have been complclcd, or thc pat ien( has made

I ill(IKCollsucutivcFailurcs errors ul B row. This I(Ink call bcused to assess visuospatial menlory and executive fluiction.

I'he results collected are simply scoring figures derivedfrom the game, alon with the details of the ames presentedand the touch inputs the participant made. for example, asfollows:

+ (RKO)deredTisk *)spat i(SpaaulemorkTaskW tl Ideat fier ( lsStrum *l dent her~)tcndctUscDeict)pt)ou (I SStl'u)g

")u)tendedl:seDes r)ptmr)mt) i( S pm) (N Slntc crlutit»(Span

at)t) )ti)BItSp)t) (NSIntc crlnt)ru))1)u»Span

pla Sp d ( ~ Sl rn I I: l)pl»Spe d

mao les)s (Nslnt p

customTar et(mage (LI(inst e)mtstomTu etlnuige

usta m TargetP(uralh arne )NS Srurm*)mtstomTu etP(uralh'arne

)cqtu)cRc kraal (BOOL)requireRmeisaloptions IRKPredcfincdTaskoption)options,

+ ! RKOrde) edTask *I fitaesseheckTsskw'h Idea) tier(. IS Su ng*I dent fier

u)tcndcra seDcscnptio)t (Nsskuu\g*)u)tcndcdLscDcscuptina

-, fi.)1m;a

(NS) ) lat o:ll rikli:tresrDur)t on.(NST melntmvoilresrDurat on

opt oas (RKPmdhtinedTssl Opt on)

opt) ns.

ao

4. Fitness Test Module

User device display screens associa(ed with an examplei)itness 'I'est Activity Module are shown in i)1(iS I IA-I I I(In the fitness task. the participant is asked to walk for aspecihed duoqtion ftypically several minutesi During tlusperiod various sensor data will be collected and renirned vialhc (dsk I lcw colltrollim s dclcgatc. This woilk! Illchiilcacceleronleter. device motion, pedometer. location, and a

hciirl rd(c da(d wtlcrc Bvallablc. Al lhc conclusion ol Iticwalk. if heart rate data is available. the participant is asked(o si( down and rcs( Ibr a period. Ddld collection conluiuesduring this period. l3y default, the task includes an instnic-tion step which cxplnuis wlmt (o do dunng lhe leaks bul tluscan be excluded with an appropriate option. All of these dataare collected from various other application pro ram inter-faces. and senalized 'I'ypically, no analysis is required to beapplied to the data.

o.

6. Cieneralized Active Task SupportA s(LTI in an active task is lust another s(cp subclass,

usually paired with a step view controller subclass. TheRcsearcl Applicauon Framework contains (m RKAc-tiveStep and RKActiveS(CPView('on(roller in its privateapplication progrum intcrfdcc subset. wluch arc the baseclasses that can be used in iniplementmg predefined tasksAmong other things, these support attactung recorder con-figurations to the steps A recorder configuration is an objectv hich indicates that data should be collected during theduration of'hc task from n sensor or database on llm device.for instance, HeatthKI(. CoreMotion„CoreLocation, oraudio fromAVFoun(bnton. Where thcsc application programinterfaces return ob(cc(a. (he Research Apphcdtion Frame-work can include support for logging them to .(SON files. Inone aspect, the underlyinn implementation for logging usesRKDatBLogger. which ivrites log files to disk. and hasfacilities for roiling thenl over when they et too large. Inonc dspccl, (lus lite logguig support also uses file protccliun.so that any scnsrtivc dale is prolcctcd even wtulc 11 is withinthc application samlbox. In onc aspect, the Research Appli-cation l)ramework's predehned active tasks use NSI)ilepro-tection(.'ornpleteUnlessOpen Ivhile writing data to disk. andthen change the file protection level on any files eneratedto NSFlleProtection('omplete when the tasl ls complete.D. Passive Data Collection Modules

In another aspect, the module may be configuruxt lo collectdale from one or morc scrmors passively without requinnginput from the user 'I'he Application lrraniew:ork mayinclude a passive data collection element that can be used in

23US 11,107,578 B2

24dn app lo cas&ly pull [us&one dais using Ihc m&oIhcr appl&-

cation on the portable computing device. such as a HealthDdia Tracking Appl&ckt&on separate lromr but u&icrlbccdblewith the Research Application lrramework in anotherdspcci, these scparateappl&canons mdy interface iluuu h a

common Opemsting Systen& of the portable computingdevice.

In one exmnple, to do so, the developer instantiates anRKStudyStore and attaches one or more sn&dies to it. Eachstudy can have one or more collectors. Typically there ivouldbc onc collector per data type, for instance, there might bcd hcart riltc I:olh:ckor, a Blot&on Bcnv&iv coll&:cio&r &I sn:pcollector, and so on

RKStudy "stud, = [s&orc addS&udvWithIdcrsificr hhuusrudvidcnr&fierdc&cga&c self

error s error).HKQuantii T pc "quan&irvTvpc = IHKQuan&njyjpc" I IHKOhic &Tvpc

quan& I&'Iip I It iiii HKQ . I OI&p Idmi fiwsi pc w1 i.

Rxuwlih('i &'h alii('ufi I» = Is& d&

,uiini;Ilh('i &OW&huu pie& p qu nl I&lipun & [HKL'n t coiui&L'n ii

siutnite ruierror grermrl.

HKQuant i&T pe *quent I, T pe = IHKQuanui, T pe* ) [HKOhiectTypequu&tiiyTypcForIdcnrificr HKQuaniiivTrpeIdcrsificrnloodoiu osclHKI nit "unit = [HKUaii &uu&Fmmstnng 'u "mg:dL"I;RKHealthCogcctor *glucoscColiccioi = [su&dyaddHcaiihC olieciorivithsunplcT, pc quantiiyType&

Once a study has been configured, when the participantjoins the study. the developer can cail updateParticipat&ngwi&hfoinDB&c.error: io u&d&cute Ihai dkIa collum1&on shouldstart. Ai I[us po&nt, the study store will request access io the1 arious data sources (pose&bly poppm up (halogs in thc Uiof the application) Then, it will start appropriate queues fi&r

each data type and start loggu&g the resuhing data[study updateParticipat&ng; YES withJoinDB&e:[NSDatedate) error:g:err),

When ncw dnta lrks bccn suc(casfully co[ice&ed fromanother appl&canon or acccssiblc dkIabasc. such as Ihaiassociated w&th a separate Hcahh Data Trackin Apphcd-tion, the developer then has to do something with it Noti-fications of the data collection are returned to the delegate tofacilitate this. The Research Application Frameworkincludes code ivhich can help with converti»g those piecesol'ais io JSON, loggu&g them Io d&sk, and notifying theilclcgdic when ihi: Ioidl slgc ol thi: logs hds Ii:dchi:I! &I cc(IBUItlucshold. 11u: line[ step is to arcluvc thc data io a com-pressed hie ready fi&r upload to a server

When the RKStudyStore and RK)tudy are active. eachRKHealthCO)lector will instantiate a observation query forthe health information database associated with anotherdpphciiuiui. II ihc apphcdnon ilcvclopc& luis g&vcn lhc&r BppIhc ilpprop&liltc cnntlcnu:nt fo& thBI iuhiu &Ippl&cat&on (I: g.Health Dais Traclong Appl&cauon)r thc application will bclmu&chad in Ihe background when data of that type has beenadded l&ach time there is new data, the study store w&11 runan HK.&d&choredOb)ectQUC&y to query for new samples.Inten&ally. the RKStudyStore tracks the last anchor success-fully read. so that only ncw Kkmples are retncved Theobscr& cr query may cause thc application io bc woken u&to

ihc bilckgtoUU(I whi:n ni:w ildtB Is ava&IBbliu 11&c ill:vi:lopershould instantiate the RKStudy)tore and resume it. at whichpoint new data will automatically be fetched

FI(iS. 13-14 illusudtc example methods of faciliiatu&gresearch with a po&table computing device of a user and oneor more modules received by the device in accordance ivithembodiments of the invention in the example of l&I(i 13,the method includes steps of: rece&ving, with a portablecomputing device, one or n&ore survey modules having oneor morc questions pcriaimng io a health research study. Iheportable computing dcvicc assoc&a&ux[ w&th a user participat-ing in the health research study: displaying, on a graphical

In user interface of the portable computing device, the one ornx&re questions based on a respective module of the one ormore modules: receiving a user input with the portablecomputing device in response to the one or more questions;op1&onally. dc-aleut&fymg Ihc u&pui data from Ihc user, andouIpuIting io a tlnrd party health rescarchcr Ihe u&put asso-c&ated v ith the instn&ction ot tbe one or n&ore modules fi&r

use &n health research relating to the study In the exampleof l&I(i. 14. the n&ethod includes steps of: receiving, with aportable computing device, one or more activity modules

10 corresponding to a sensed paran&eter pertainin to a healthresearch snxly. Ihc portable comput&ng devwc assocrkiux[w&the user partrc&puting u& the research study, ihsplayu&g, ona graphical user interface of the portable computing device,an &natu&ction to perform the task based on a respectivenx&dule of the one or more modules: receiv&ng an input ofthe parmneter from one or nu&re sensors assoc&ated with theportable computing device concurrent with the user per-forming ihc instructed acus ity. Up 1iooally, dc-xlenufying thcinput dais from ihe user, and outputt&ng to a Ih&rd party

&0 health researcher the inpm associated w&th the instn&ction ofthe one or more modules ti&r use in health research rehsting,to the study.

Illustrative methods and systems for managing userdevice connections are described above. Some or all of these

&s systems and methods may. but need not. bc &mplcmenicd ailcas1 partially by urchitcciures such us those shown a& leastiu FI(IS. 1-14 above. Wlulc many ol'hc embodiments aredescribed above v,ith reference to personal and/or health-related infi&rmation, it should be understood any type ofuser

kn information or non-user information may be managed usingthese technique~. Further. in the forego&ng description, vari-ous non-limiting exnmplcs werc dcscnbixl. For purposes ofexplanation, spccilic conliguranons and dehiils are set I'orth

iu order to provide a thorough understanding of thcexan&plea It is appreciated that the alx&ve exan&plea may bepracticed v;ithout certain specific details and that we[[-known features were son&etimes om&tted or simplified inorder not to obscure the exan&pie being described.

Thc various emboduncnis lurther cdu be nuplemcntcd in0 a w&dc vanciy ol'pcraung env&roumcnts, wluch u& some

cases can Include onc or morc user computers, compuiu&gdevices or processing devices ivhich can be used to operateany of a number of applications User devices (e.g. clientdevices) can include any type of general purpose personal

o. computer such as. but not lin&ited to„desktop or laptopcomputers runnu&g d sim&dard operut&ng system, as weil ascellular, w&relcss, and/or lumdhcld devices runnu&g mobilesoftware and capable of supporting a number of ue&wor)ungand messaging protocols 'I'hese devices can also include

(0 other electronic devices. such as dummy terminals. thin-clients. gamin systems. or other devices capable of com-municating via a network.

Most cmbod&ments util&kc at least ouc network tl&ai wouldbc fiunil&ar 10 those skilled u& Ihc urt for supporiu&g com-

Ss nnnucal&ons Usu&g any'&I d &ill&l:I)'f conuncrc&allv'-Iiva&1-able protocols, such as T('V,'IV. OSI. I&TV. Upnp, NFS ('ll'5,,and Apple[elk [he neuvork can be, fi&r example, a local

US 11,107,578 B22i

dred network, a wide-arcs network, a virtual private net-work. the Internet, an Intranet. an extranet, a public switchedtelephone network, an infrared network. a tvireless network,and any combination thereof.

The envimmnent can include a variety of data stores andother memory and stora e media as discussed above. Thesecan rcsuic ul B variety'l loi"tlions, stick Its on B stoiitgcmcdnun local Io (and/or rcsxlcnt ui) one or more of thecompmers. Alternatively, the memory can be remote frontany or all of the computers acmss the network. In aparticular set of enibodiments. the inforination may reside ina storage-area network (SAN) fmniliar to those skilled in theart. Similarly, any necessary files for performin the func-tions attributed to thc computers, servers or olhcr nciworkdcviccs may be stored locally mid/or remotely, as desired.

'Ihe system and various devices may also include one ormore sof13vare applications, modules. services. or otherelements located within at least one working memorydevice. includin an operating system and application pro-rams. such as a cheat apphcation or browser. It should be

appriwiated that altcniatc embodiments may lxtvc niuncrous1 ariauons from that descnbed above. For example, custum-ized hardv are might also be used and/or particular elenientsniight be implemented in hardware. software (includingportable software, such as applets) or both. Ilurther, connec-tion to other computing devices such as network input/output devices may be employed.

lhc speciiicduon Bnd dmwuigs are, dccordmgly, to bcregarded ui an Illustrative rather lhan a reslnclive scuse. II

will, hov ever, be evident that various modifications andchanges may be made thereunto without departing from thebmader spirit and scope of the discklsure as set forth tn theclaims.

Other variatlons are within the spirit of the presentdisclosure. Thus, while the disclosed tccluuques arc susc&3I-

tibia to various mo&hlications lmd alternatw e constructions,c&rlain Illustrated cmbodimenm Ihercol arc shown ui thedrawings and have been described above in detail It shouldbe understood, however, that there is no intention to limit thedisclosure to the specific fomi or forms disclosed. but on thecontrary. the intention is to cover all modifications. Blterna-ute conslnictions and cquivalmim lalluig v,itlun Ihc spimldnd scope ol'hc disclosure, as dctined ui tlm appcndcsIclduus.

'Ihe use of the ternis "a*'nd "an" and "the" and similarreferents in the context of describing the disclosed embodi-ments (especially in the context of the following cLsims) areto be constnied to cover both the siligular and lhe plural,unless otherwisc Indicated hcrcin or clearly contra&lictcd bycontext. Thc Icnns "comprising." '*havuig." "mcluduig,"and "contaimng" are lo bc construed as open-cndcd lcrnw(i e. meanin "including, but not limited to,") unless oth-etwise noted. 'I'he tenn "connected" is to be construed aspartly or ttholly contained within. attached to. or joinedtogether, even if there Is something intervening. Recitationof ranges of values barmn are mcrcly mtended to serve as ashorthand method of referring uidividually to each separateValue falling within thc range, Unless oth&xwlsc unlicau:ilherein, and each separate value is incorporated into thespecification as if it were individually recited herein Allmethods described herein can be performed in any suitableorder unless otherwise indicated herein or otherwise clearlycontradicted by context. The use of any dnd all cximiples. orcxcnipldry ldngtlBgc (c.g., stick Bs ) plovl&lixl hixcut. Isintend&xi nu:rely to bauer illumumtc cmboduncnts of thedisclosure and does not pose a limitation on the scope of thedisclosure unless otherwise claimed. No language in the

What is cLsimed isI A method for facilitating health research, the method

lo conlprlsulg:stoung prcdclincd first-party lmdlth research modules ui a

computer system, wherein each of thc predelincd Iirst-party health research modules are performable by ahealth data tracking application that Is executable by aportable computing device,

receiving, by the computer system. one or more third-party heaith research niodules and a selection thatdemgimtcs onc or more of thc prcdcfin&XI Iirst-partyhealth research modules, win:rein each of thc one ormore third-party health research niodules are perform-able by the health data trackin apphcation. whereinthe one or more third-parry research niodules are asso-ciated with a health researcher, and w herein the one ormore third-party research modules and the one or moreof Ihc prcdctined first party health rcscarch modulesdcsigtmtcd by thc selection arc associated with a healthrcscarch study,

tmsnsmitting, by the computer systeni, the one or morethird-party health research modules to the portable

do computing device;transmitting. by the computer system, the selection and/or

onc ol nlorc oi thc onc or Biol'i ol lhc prcdclinix!Iirst-party health research modules designated by thcsclcction to the portable compuung dcvicc:

receiving, by the conipmer system, subject response datafrom the pottable computin device, wherein the sub-ject response data is genemsted by the portable com-puting device in response to input to the portablecomputing dcvicc in response lo pcrformimcc by Ihe

U portable computing dcvicc ol the onc or morc Ihird-party hcBlth Icscdrch nltxlUlt:s dnd lhc onc or nlole oithe predefined first-party health research modules des-ignated by the selection; and

transmitting. by the computer system, the subjectss response data to the health researcher

2 Thc method of clmm I Ihrther comprisuigde-idmitilying thesubjecl response data Irom llm sublecl

beliirc output ung Ihe subject rcsponsc dale to Ihe healthresearcher.

&o 3 'I'he method of claini I, wherein the subject responsedata comprises sensor output genemsted via one or moresensors associated tvith the portable computing device.

4 The method ofclaim 3, wherein thc one or morc sensorsilclccl tiny'f: itctivitv It:vcl, dcllvity'&Bckulg, rcspudlion,

ss body Imnpcralure, heart wellness dale, hydration lcvcls,perspiration, blood glucose..salinity, sleep cycles, posture,02 levels, muscle engagement, or any combination thereof

3&

26specilicalion should bc construed as indicaung any non-claimed element as essential to the practice of the disclosure

Any of the methods described herein niay be totally orpartially performed with a computer systeni includuig one ormore processors. which can be configured to perform thesteps. Thus, embodiments can be directed to computersystems coniigured lo perform thc steps of any of Ihemethods dcscnbcd hcrcui, potenually with dillbrcnt compo-nents performing a respective steps or a respective group of

Ill steps. Although presented as nunlbered steps, steps ot nieth-ods herein can be perfornied at a same time or in a ditferentorder. Additionaily, portions of these steps may be used withportions of other steps from other methods. Also, all orportions ol a stop mdy be optiomil. Additionally, any of thcsteps of any of Ihc methods can bc pcrlhmicd with modules.circuit~, or other nieans for performing these steps

27US 11,107,578 B2

285. The method of clnun 3. wherein.the sensor nutput is generated over a duration of time: andthe sensor nutput is generated via measuring a sensor

parameter based on an intemnction by the subject v iththe portable computing device.

6. The method of claim 3, wherein the sensor ontput Ispassncly collected from Ihe onc or morc sensors willxiulrcxlutnng an interacuon by the subject with tlm portablecompminn device

7 I he method of claini 1, wherein the third-panv healthresearch modules and the one or more of the predefinefirst-party research models desi@lated by the selectionefi'acts a survey and/or an activity accomplished by thesublccl.

8. lite method of claim 1, whcrcin lhc onc or more of thcpredefined first-party health research modules comprise oneor niore predehned first-party survey modules that requestinformation fmm the subject regarding eligibility of thesubject to participate in the health research study.

9. The method of claim 1. v herein the one or more of thepredefined Iirst- party lmalth rcscarch modules compnsc oneor more prcdeiined lirst-party consenl modules thai rcxlucstinput fmm lhe sublect indicative of consent of the subject toparticipate in the health research study

1(I. 1 he method ofclaim 3, wherein the one oi'li1re of thepredefined first-patty health research modules comprise oneor more predefined first-party active task modules that askIhe sub(em( to pcrlonn a task during wluch the sensor outputIs gciici incxl.

11 'I'he method of claim 3, wherein the one or more of thepredefined first-party health research modules comprise oneor more predefined (irst-party passive data cnllection mod-ules configured to collect the sensor output passively with-out input from the subject.

12. Thc method of claim 1, further compnsing:receiving health uilhnnauon of thc sublccl (born an elec-

tronic medical record of Ihc sublect,generatiim de-identified health information of the subject

by de-identifying the health information of the subjectfront the subject; and

transmitting the de-identified health infomintion of thesubject to thc health rcscarchcr.

13. Sk computer syslmn for facihlatm health rcsmirch, thcCoillpii(CI Sv's(CIII I:Oillprisiilg:

one or more pmcessors, anda computer readable medium storing coinputer executable

instnictions and predefined first-party health researchmodules, wherein each of the predefined first-partyhealth research modules are perl'ormablc by a healthdata uacking applicauon that is cxccuuible by a por-table computing device. and whereui Ihe computerexecutable mstnictions are executable by the one ormore processors to cause the computer system tn:receive one or more third-party health research mod-

ules and a selection that designates nne or more oflhc predclincd Iirsl-party health research modules,wherein each ol'hc onc or more llnrd-party hmilthresearch modules are pcrfomuible by the health datatracking application, wherein the one or nxire third-party research modules are associated with a healthresearcher, and v herein the one or more third-partyresearch modules and the one or more of the pre-delined lirst party health research modules ilcsig-naled by lhe sclecuon arc associalcd with a hcallhrcsctiich sluilv:

transmit the one or more third-party health researchmodules to the portable computing device:

transmit the selection;md/or onc or morc of the onc ormore of the predefined Iirst-party health researchmodules designated by thc selection to thc portablecomputing device:

reccivc sublcct rcsponsc dale from thc portable com-puting device, wherein the subject response data is

enerated by the portable computing device inresponse tn inpm lo the portable computing device inresponse to perfonnance by the portable computing

I it dcvicc of Ihe onc or morc third-party health researchmoduies and the one or more of the predefinedIirst-party health research modules designated by thcselection; and

transnul Ihc subject response dale lo lhc healthresearcher

14. The computer systeni of claim 13„w herem the com-puter executable instnictions are further executable by theone or more processors to cause the computer system to

Ic dc-nlcnlify Ihc subiccl response data I'rom the subjccl bcforcoutputting the subject response (Ltta to the health researcher.

15. Thc computer system ol claim 13, whereui the sublcclresponse data coniprises sensor output generated via one ornxire sensors associated ivith the portable computmg device

16. 'I'he computer system of claim 15, wherein the one ormore sensors detect any of; activity level, activity tmckhtg,respiration. body temperature, heart wellness data. hydrationlcvcls, perspiration. blooii glucose, aalu»ty, slccp cycles.posture, 02 levels, muscle cngagcment, or nny combiimtion

ic thereof.17 'I'he computer system of claim 15, whereinthe sensor output is generated over a duration of time; andthe sensor output is generated via measuring a sensor

parameter based on an interaction by the subject with11 thc portablecompunng devwe.

18. Thc computer system of claim 15, whcrcin thc sensoroutput is passively colleclixi from lhc onc or morc sensorswithout requiring an interaction by the subject with theportable computing device

to 19. The computer systeni of cLaim 15„wherein the one ormore of the predefined first-party health research modulescompnsc one or more prixiclined Iirsl-party active iaskmodules thai ask Ihe subject to perform a task during wluchtile scnsol oii(piil ts gciiciiiicxl.

2(l 1 he cnmputer svstein of claiiii 15, ivherem the one ormore of the predefined first-party health research modulescomprise one or more predefined first-party passive datacollection modules configured to collect the sensor outputpassively without input from Ihc sublcct.

o 21. Thc computer system of claim 13. whereui thc Qurd-party health research modules and thc one or morc of Ihepredefined first-party research models designated by theselection etfects a survey anchor an activity accomplished bythe subiect.

s. 22. The computer systeni of cLaim 13„wherein the one ormorc of the prcdelincd lirst-parly health research modulescompnsc onc or morc predelincd lirst-party survey modulesthat rcx(ucsl information from tlm sublect regarding chgibil-ity of the subject to participate in the health research study

sl! 23 qhe cnmputer svstein ofclaiiii 13, ivherem the one ormore of the predefined first-party health research modulescomprise one or more predefined Iirst-party consent modulesthai rcqucst input from Ihc subject uidicauvc of consent ofthe subfect to participate in the health research study.

ss 24. The computer system oi'laim 13, whermn thc com-puter executable instnictions are further executable by theone or mnre processors lo cause the computer system to

29US 11,107,578 B2

30rccclvc health nllolnlatlon of Ihi'. subiccl hiun Bn el~-

ironic medical record of the subject;generate de-identified health inforlnation of the subject by

de-identifying the health inforlnation of the subjectfrom the subject: and

transnlit the de-identified health infomlation ofthe subjectIo the health rcscarcher.

25. A computer rcadablc mixinun stonng computerexecutable instnlctions executable by one or more proces-sors of a conlputer system to cause the computer system to

store predefined first-party health research modules,wherein each of the predefined first-party healthresearch modules are performable by a health datatracking apphcauon tlrat ls cxccutablc by B portablecomputing device.

receive one or more third-parry health research modulesand a selection that designates one or more of thepredehned hrst-party health research modulex whereineach of the one or more third-party health researchmodules are performable by the health data trackingapphcatlon, whcrcul Ihc one or morc liard-partyresearch modules are associaled wilh a hcallhresearcher. and wherein the one or more third-partyresearch modules and the one or more of the predefinedfir:t party health research modules designated bv theselection are associated with a health research study:

transmit the one or more third-palsy health researchmodules Io Ihc poruiblc computulg device.

transmit the selection mldlor onc or morc of thc one ornlore of the predefined first-party health research mod-ules designated by the selection to the portable conl-puting device,

receive subject response data from the pormble computingdevice. wherein the subject response data is generatedby Ihc portable computing device ul response Io inputIo Ihc portable computulg device m response Io per-formance by thc portable compuung device of Ihc oneor more third-party health research nxldules and theone or more of the predefined first-party health researchmodules designated by the selection: and

transmit the subject response data to the health researcher.26. The computer readable mcihum of claim 25, whcrcln

the computer cxecutablc lnstrucuons are further executableby ihe onc or morc processors to cause thc compuler syslmnto de-identify the subject response data from the subjectbefore outputting the subject response data to the healthresearcher.

27. The computer readable medilun of claim 25, whereinthc subicct rcsponsc data comprises sensor output gmleratcd1 la onc or more sensors associated with thc portable com-puthlg ilci icc.

Zg. I'he conlputer readable mediuln of claim 27. v hereinthe one or more sensors detect any of activity level. activitytracking, respimstion. body temperature. heart w:ellness rksta,

hydralion levels. perspiration. blood glucose, sahnity. Slcc71

cycles, posture, 02 levels. muscle engagenlent, or anycombination thereof

29. The computer readable nledium of claim 27, whereilu

the sensor output ls gcncratcxl overs durauon ol'une, and

the sensor output is generated via nleasuring a sensorparameter based on an interaction by the subject withthe portable computing device.

la 30. Thc computer rendablc medium of clmm 27, whereinthe sensor output is passively collected from the one or morescnsolswithout rcqun1ng Bn nltcl'action by'hc subject w'1th

the portable computing device.

31. Thc computer rendablc medium of clmm 27, whereinthc one or morc of Ihc prcdclincd lirst-party health researchmodules comprise one or more predehned first-parry activetask nlodules that ask the subject to perform a task during,v hich the sensor output is generated

32. Thc computer rendablc medium of clmm 27, whereinthc one or morc of Ihc prcdclincd lirst-party health researchmodules compnse onc or morc predclincd lirst-pany passivedata collection nlodules configured to collect the sensoroutput passively ivithout input from the subject.

33. The computer readable medium of claim 25, whereinthc third-party health research modules and thc onc or morcof thc prcdciined lirst-party research models designated bythe selection etfects a survey and/or an activity accom-phshed by the subject

34. The computer readable medium of claim 25, whereinthc one or morc of Ihc prcdclincd lirst-party health researchmodules comprise one or morc prcdclined lirst-party surveymodules that request ulformauon from tlm sublcct rcgardulgeligibility of the subject to participate in the health researchstudy.

35. The computer readable medium of claim 25, whereinthc one or morc of Ihc prcdclincd lirst-party health researchmodules compose onc or morc predelincd lirst-party conscnlmodules that request input front the subject indicative ofconsent of the subject to participate in the health researchstudy.

36. Thc computer rendablc medium of clmm 25, whereinthc computer cxccutablc instnicuons are further cxccutablcby Ihc onc or morc processors Io cause thc computer systemlo

receive heaith information of the subject from an elec-tronic medical record of the sublectt

generate de-identified health information of the subject byde-identii'ying the health information of the subject

o front the subject; and

transmit the dc-ident diixl health ulfonnation of I 1m sub lint Iothe health researcher.

Documents

Patent US B2 Nag Date of Patent: Ang