m Health Recommendations

8/13/2019 m Health Recommendations

1/28

mHealth

Task ForceFINDINGSANDRECOMMENDATIONS

Improvingcare

delivery

through

enhanced

communications

amongproviders,patients,andpayers

PrePublicationPublicDraft

September24,2012

mHealthTaskForceCoChairs:

JulianGoldman,MedicalDirectorofBiomedicalEngineering,PartnersHealthcare

System;Director,CIMITProgramonInteroperability;AttendingPhysician,

MassachusettsGeneralHospital

RobertJarrin,

Senior

Director

of

Government

Affairs,

Qualcomm

Incorporated

DouglasTrauner,CEO,HealthAnalyticServices,Inc.(TheCarrot.com)


2/28

TableofContents

ExecutiveSummary........................................................................................ 1

Introduction...................................................................................................

2

mHealthTaskForceRecommendations........................................................5

Goal1:FCCshouldcontinuetoplayaleadershiproleinadvancingmobile

healthadoption............................................................................................ 5

Goal2:Federalagenciesshouldincreasecollaborationtopromote

innovation,protectpatientsafety,andavoidregulatoryduplication..........6

Goal3:TheFCCshouldbuildonexistingprogramsandlinkprograms

wherepossibleinordertoexpandbroadbandaccessforhealthcare........10

Goal4:TheFCCshouldcontinueeffortstoincreasecapacity,reliability,

interoperabilityandRFsafetyofmHealthtechnologies.......................... ..12

Goal5:Industryshouldsupportcontinuedinvestment,innovation,andjob

creationinthegrowingmobilehealthsector............................................ 14

Conclusions.................................................................................................. 16

Endnotes...................................................................................................... 17

AppendixI Barriers&Opportunities.18

mHealthTaskForceCoChairs....21

mHealthTaskForceParticipantList.23


3/28

Page1

ExecutiveSummary

InJune2012FederalCommunicationsCommission(FCC)ChairmanJuliusGenachowski

assembledagroupofthenationsleadingwirelesshealthcaretechnologyexpertsfrom

industry,government,andacademiaforasummitonmHealth.i Thegoalwastoassess

theopportunitiesandchallengesfacingtheadoptionofwirelesshealthtechnologies.

TheoutcomeofthiseventwasthecreationofaTaskForcebytheparticipantsto

developconcreterecommendationstoacceleratetheadoptionofmHealth

technologies. ChairmanGenachowskiaskedDr.JulianGoldmanofCIMIT/MGH/Partners

HealthCare,RobertJarrinofQualcommIncorporated,andDouglasTraunerofHealth

AnalyticServices,Inc.(TheCarrot.com),tovolunteertoleadthiseffort.

Overthesummerof2012,themHealthTaskForcesetitsprioritiesandconducted

extensiveindustryoutreach,whileaddingmembersalongtheway.Throughoutthis

process,

the

Co

chairs

held

numerous

working

group

meetings,

created

a

shared

online

collaborationenvironment,andinterviewedmanystakeholdersacrossthespectrumof

healthcare,healthIT,andcommunications.

WhilemHealthtraditionallystandsformobilehealth,thisTaskForceadoptedthe

termmorebroadlytorefertomobilehealth,wirelesshealth,andeCaretechnologies

thatimprovepatientcareandtheefficiencyofhealthcaredelivery.ii

ThisTaskForcereportsetsgoalsandrecommendationsfortheFCC,otherfederal

agencies,andindustrytohelpleveragecommunicationtechnologiestoimprove

healthcarequality,accessandefficiency.

Thisreportisdeliveredwiththeoverarchinggoalthatby2017mHealth,wirelesshealth

andeCaresolutionswillberoutinelyavailableaspartofbestpracticesformedical

care. FCCleadershipaswellasinteragencycollaborationswillbeneededtoaddress

technicalandpolicybarriers,includingdevelopingappropriatereimbursementand

financialincentives.

Thereportrecommendationsareorganizedwithinthefollowingfivegoals:

Goal1: FCCshouldcontinuetoplayaleadershiproleinadvancingmobilehealth

adoption.

Goal2:

Federal

agencies

should

increase

collaboration

to

promote

innovation,

protectpatientsafety,andavoidregulatoryduplication.

Goal3: TheFCCshouldbuildonexistingprogramsandlinkprogramswhen

possibleinordertoexpandbroadbandaccessforhealthcare.

Goal4: TheFCCshouldcontinueeffortstoincreasecapacity,reliability,

interoperability,andRFsafetyofmHealthtechnologies.

Goal5: Industryshouldsupportcontinuedinvestment,innovation,andjob

creationinthegrowingmobilehealthsector.


4/28

Page2

Introduction

HealthcaredeliveryisatacriticaljunctureintheU.S.bothintermsofqualityandcost.

TheU.S.ranks37th

intheworldforhealthcaresystemperformance,iiiyetspendsmore

onhealthcare

per

capita

and

more

on

healthcare

as

percentage

of

its

GDP

than

any

othernation.iv TheInstituteofMedicinerecentlyreportedthatthetotalwasteinthe

healthcaresystemcouldbeashighas$765billionannuallyandstudieshaveestimated

thatthereareover75,000preventabledeathsperyear.v Thereportgoesontodescribe

howadvancesinmobilecommunicationshavedramaticallychangednumeroussectors

oftheU.S.economy,andevensocietymorebroadly.

TheU.S.iscurrentlytransitioningfrompaperbasedhealthrecordstoElectronicHealth

Records(EHRs)andsecurehealthcarecommunicationstechnologies.Inparallel,mobile

healthtechnologyisplayinganincreasingroleinprovidingaccesstoqualitycareforall

Americans.

Access

and

availability

of

high

capacity

wired

and

wireless

telecommunicationsservicesarecriticaltothesuccessofanimprovedhealthcare

deliverysystem.

mHealthcanimprovepatientcareandcreatecostsavingsbycapturinginformationfor

providersandallowthemtorapidlyanalyzelargeamountsofinformationtobetter

understandapersonshealthtrendsovertime. mHealthalsooffersthepromiseof

givingpatientseasieraccesstotheirhealthinformation,anditallowstheminingofdata

toimprovecosttransparency,increasingefficienciesacrossthecontinuumofcare,and

enablingmoreaccuratediagnosisandtreatment.

Specificexamples

of

mHealth

(including

wireless

health

and

eCare

solutions)

include:

Medicaldevicesthatactasremotepatientmonitorsusedinclinical,home,mobile,andotherenvironments.

Mobilemedicalandgeneralhealthsoftwareapplicationsthatallowpatientstouploadordownloadhealthinformationatanytime.

Medicalbodyareanetworksensorsthatcaptureandwirelesslyforwardphysiologicaldataforfurtheranalysis.

Medicalimplantdevicesthatallowneuromuscularmicrostimulationtechniquestorestoresensation,mobility,andotherfunctionstoparalyzedlimbsand

organs.

Medicaldevicedatasystemsthatallowforthetransfer,storage,conversion,ordisplayofmedicaldatathroughwiredorwirelesshubs,smartphones,or

broadbandenabledproducts.

Mobilediagnosticimagingapplicationsthatallowdoctorstheflexibilitytosendorreviewmedicalimagesfromvirtuallyanyplace,andatanytime.

Patientcareportalsthatcanbeaccessedanywhereforselfreportingandselfmanagement.


5/28


6/28

Page4

TheFCCplaysanessentialroleinenablingnewhealthcaretechnologiesthatrelyon

wirelesscommunicationsandbroadbandconnectivity.Sincethepublicationofthe

NationalBroadbandPlanin2010,theFCChasmovedforwardwithmanyofthe

healthcaresectionsimportantrecommendations,suchasapartnershipwiththeFood

andDrugAdministration,dedicatingspectrumforMedicalMicropowerNetworks,and

settingprecedent

as

the

first

agency

in

the

world

to

allocate

spectrum

for

Medical

Body

AreaNetwork,orMBAN,devices.

Modernizingthehealthcareecosystemisanationalprioritythatrequiresclose

collaborationandprioritizationamongallstakeholders,particularlywithfederal

agencieswithintheDepartmentofHealthandHumanServices(HHS)vii,theVeterans

Administration(VA),theNationalScienceFoundation(NSF),theNationalInstitutesof

Health(NIH),theDepartmentofDefense(DoD),theDepartmentofCommerce(DoC),

theUnitedStatesDepartmentofAgriculture(USDA),andtheNationalInstituteof

StandardsandTechnology(NIST).Suchcollaborationiscriticaltoreducingthebarriers

foradoptionandtheongoingsuccessofinnovativehealthcaresolutionssuchas

mHealth,wireless

health,

and

eCare.

ThefollowingrecommendationsarearesultofthecollectiveeffortsofthemHealth

TaskForceandreflecttheneedtofacilitateeCaresolutionsincluding,butnotlimitedto

mobileHealth.


7/28

Page5

mHealthTaskForceRecommendations

Goal1: FCCshouldcontinuetoplayaleadershiproleinadvancing

mobile

health

adoption.

1.1. TheFCCshouldfilltheopenpositionforFCCHealthcareDirector.TheFCCshouldappointaHealthcareDirectorresponsibleforsupporting

theregulatoryneedsofthehealthcaretechnologysectorandworking

towardthegoalofimprovinghealthcaredelivery. Thisofficeshould

provideasinglepointofcontactforaddressinghealthcarerelated

barriersandopportunities. TheHealthcareDirectorshouldserveasan

importantliaisonwithotherfederalagenciesandshouldscheduleregular

meetingswithHHSandotherfederalstakeholderstofieldquestionsand

discussidentifiedbarriersandgaps.

ThemembersofthemHealthTaskForceshouldbecontactedifandwhen

thepositionispostedandassisttheFCCinconductingoutreachtoattract

talentedapplicants.

1.2. TheFCCandotheragenciesshouldimproveeducationaloutreachactivitiestohealthcareorganizations.

Manynonprofithealthcarefoundations,researchinstitutionsandsmall

companiesareunfamiliarwiththeprocessesandlegalproceduresthat

mustbefollowedtorevisetheCodeofFederalRegulationsinorderto

introduceinnovativetechnologies.

TheFCCandotheragenciesshouldhighlightavailableresourcestohelp

nontraditionalconstituentsmosteffectivelyworkwiththoseagencies.

Thisshouldincludeaneasytonavigatesetofeducationalmaterialson

theFCCswebsitedesignedforanaverageconsumer. Administrative

rulesandproceduresshouldbereviewedwiththegoalsofeaseofuse,

logicalprocesses,andflexibility.


8/28

Page6

1.3. TheFCCshoulddevelopandlaunchahealthcarewebsite.TheFCCshouldhaveasectionundertheFCCpublicwebsitededicatedto

healthcare,wirelesshealth,healthITnomenclature(seealso:2.6),medicalspectrum,andtheNationalBroadbandPlan(NBP)Chapter10on

healthcare.The

section

on

Chapter

10

of

the

NBP

should

provide

status

updatestotrackFCCseffortstoimplementthevarious

recommendations.ThissiteshouldprofiletheFCCsongoingworkand

effortsinthoserelatedfields.

ThisproposedFCChealthwebsiteshouldalsoincludelinkstoother

federalhealthcarewebsites,initiativesandpoliciesrelatedtomobile

healthandserveasaclearinghouseforthepublicandindustry.

Additionally,thiswebsiteshouldincludethevariouseffortsandprojects

FCCisundertakingwithotherfederalentitiestoaddresshealthcare

barriers.

1.4. TheFCCshouldcontinuetoseekpublicinputandfurtheritsengagementwiththemHealthTaskForce.

ThemHealthTaskForcehasidentifiedseveralopportunitiesandbarriers

tomHealthadoptionwithactionablerecommendationsfortheFCCand

otheragencies. TheFCCshouldcontinueworkingwiththeTaskForceto

builduponitsinitialfindings. Examplesoffurthercollaborationinclude:

EstablishthemHealthTaskForceasaformalinteragencyexternalworkinggroup.

Seekadditionalinputfromtheprivatesectorthroughengagementwithpublicprivatepartnershipinitiativesestablished

bytheNIHandFDA.

Goal2: Federalagenciesshouldincreasecollaborationtopromoteinnovation,protectpatientsafety,andavoid

regulatoryduplication.

2.1. TheSecretaryofHHSshouldconveneaformalworkinggroupaspermitted

under

the

FDA

Safety

and

Innovation

Act

(FDASIA)

of

2012.

UnderSection618ofthe2012FDASafetyandInnovationAct,the

SecretaryofHHSactingthroughFDA,ONC,andFCC,shallpostonthe

websitesofthoseagenciesareportthatcontainsstrategyand

recommendationsonhealthITincludingmobilemedicalapplications.


9/28

Page7

TheActallowstheSecretaryofHHStoconveneaworkinggroupof

externalstakeholdersandexpertstoprovideappropriateinput. FDA,

ONC,andFCCshouldencouragetheSecretarytoconvenetheworking

groupandleveragethefindingsandrecommendationsofthemHealth

TaskForce.

2.2. FCCandFDAshouldcontinuetoacceleratetheirongoingcollaborationandprovideregulatoryclarityonoverlappingissues.

TheFCCandFDAsignedajointMemorandumofUnderstanding(MoU)in

2010toimprovetheefficiencyofwirelessmedicaldeviceregulation.

Sincethen,theagencieshaveworkedtogetherinavarietyofwaysto

implementtheMoUandadvancemobilehealth,includingengagingthe

publicthroughaworkshopinlateJuly2010. TheFCCandFDAshould

continuetoseekmorepublicengagementwiththeirongoingefforts

relatedtoconvergedmedicaldevices. Theagenciesshouldalsomove

quicklyon

specific

actions,

including:

Continuingtoprovideexpertiseonconvergedmedicaldevices(Example:FCCsinvolvementinfinalizingFDAs2007DraftRadio

FrequencyWirelessTechnologyinMedicalDevicesguidance

document).

ExtendingtheworkinitiatedundertheNBP(Example:theagenciesshouldjointlydevelopanddeliveranupdatetotheworkperformed

infurtheranceofthehealthcarerecommendationsintheNBP).

2.3. FCC,ONC,andCMSshouldseekaclosercollaborationrelatedtoongoing

health

IT

and

information

exchange

efforts.

TheFCCshouldbeconsultedandbeinvitedtohaverepresentation

duringongoingrulemakingefforts,includingONCfederaladvisory

committeemeetings,relatedtotheMedicareandMedicaidEHR

incentiveprogramandthedevelopmentofstandardsandcertification

criteriaforEHRtechnologies.

AsdemonstratedintheCMSFinalRuleforStage2oftheEHRIncentive

PaymentProgram,somehealthcareprovidersmayqualifyforexclusion

ofameasureiftheylackacertainthresholdofbroadbandcapacity.

Tosetthethreshold,CMSusedtheFCCs3Mbpsthresholdascriteriafor

excludingeligiblemedicalprovidersfrommeetingcertainrequirements,

basedonanumberofpatientencountersincountiesthatdonotmeeta

percentageofhousingunitswith3Mbpsbroadbandcapacity.viii


10/28

Page8

TheFCCmayplayahelpfulroleinframingthisorotherhealthcare

providerexclusionsbasedonbroadbandavailabilitybysharing

informationonbroadbandaccesswithONCandCMS.

Furthermore,FCC,ONC,andCMSshouldsharedataonprovidersthat

qualifyfor

exemptions

with

the

goal

of

improving

broadband

coverage.

AsCMScontinuestherulemakingprocessfortheEHRIncentivePayment

Program,theagenciesshouldproactivelyidentifyopportunities.

2.4. TheFCCandCMSshouldseektoshareandacquiremoredatafromeachotheronthebroadbandneedsofhealthcareprovidersaswellasother

healthrelatedservices.

FCCandCMSshouldexplorehowtosharedataonruralhealthcare

providersthatlackbroadbandconnectivity.

Sharedinformation

on

broadband

could

help

both

agencies

to

jointly

developcreativeprogramsthattargetmedicalshortageareas. The

agenciesshouldthenfocusoutreachinidentifiedareastoinformeligible

entitiesabouttheavailabilityofprogramfundsandseektosimplifythe

applicationprocessforinterestedentities.

AnExample:PresentlytheCMS,throughitsCenterforMedicareand

MedicaidInnovation(CMMI),islookingtotransformMedicare,Medicaid,

andtheChildren'sHealthInsuranceProgram(CHIP)throughnon

traditionalprogramsandmodelprojectsthatmayincludetheuseof

healthIT. TheFCCshouldcoordinatewithCMSandtheCMMIonhow

programscan

be

leveraged

to

fund

broadband

services

for

connectivity

(FCC)andfundingformHealthsolutions(CMMI)whichcanservetotest

innovativehealthITincentivesorreimbursementmechanismsfor

mHealth,wirelesshealth,andeCaresolutions.

2.5. TheFCCshouldexplorehowtosharespecifichealthdatabetweenfederalagenciestoimprovepopulationhealth.

TheFCC,USDA,DoC,andHHSshouldexplorehowbesttoutilizewireless

coveragedata,censusdata,andhealthdatastatisticstodevelop

solutionsthatimproveaccessandservicesforrural,suburban,andurban

populationsalike.

The

agencies

should

utilize

existing

data

to

determine

ifareaswithpoorconnectivityalsoexperiencepoorerhealthoutcomes.

Sharedinformationcanhelpfederalagenciesidentifyavailableprograms

andfundingforunderservedpopulationsandlocations. Otheragencies

thatshouldcollaborateincludeNIH,HRSA,AHRQ,CDC,andtheUS

CensusBureau.


11/28

Page9

Additionally,FCC,USDA,DoC,andHHSshouldworktogethertoauditand

verifythedatareportedontheNationalBroadbandMap. This

informationisincreasinglyimportantaseligibleprovidersseektoachieve

themeaningfuluseofcertifiedEHRsandfuturepatientengagement

requirements.

2.6. TheFCCandotheragenciesshouldstandardizehealthtechnologynomenclatureacrossfederalagencies.

ThereisnocommonnomenclaturefortermssuchasmHealthandeCare

acrossfederalagencies(ONC,FDA,CMS,NSF,HRSA,NIH,etc.). Inthe

NBP,theFCCprovidedaglossaryforsomepopularyetundefinedterms.

Theabsenceofacommonnomenclatureisabarriertoeffective

collaborationandisespeciallyproblematicwhentermsareused

inconsistentlyinregulatorydevelopmentandpolicyimplementation.

Federalagencies

should

collaborate

with

the

FCC

to

develop

acommon

nomenclature. Werecommendthatonceagreedupon,theglossaryof

commonnomenclaturebepublishedonlineforagenciesaswellasthe

publictouseasareference. Maintenanceandupdatingshouldbedone

throughfederalagencyconsensusandpubliccommentprocess.

2.7. FCCshouldprovideexpertiseandresourcestoONCfortheadoptionofsecurehealthmessagingandcommunicationstandards.

Facilitatingcommunicationbetweenhealthcareprovidersandpatients

continuestobeachallengeforimprovingthedeliveryandcoordination

ofcare.

Paper,

mail,

and

fax

continue

to

be

the

predominant

means

of

communicationamonghealthcareorganizations,providers,andpatients.

ONC(withinputfromotheragenciesliketheFCC)shouldsupportthe

broadadoptionofsimple,secure,scalable,standardsbasedmeansof

sendingauthenticatedmessagesandencryptedhealthinformation

directlytoknown,trustedrecipientsovertheInternet.Forexample,the

ONCinitiatedDirectProjectispartoftheNationwideHealthInformation

Networkandprovidesstandards,services,referenceimplementation,

workgroups,models,anddocumentation. FCCandONCshouldprovide

expertise

and

applicable

resources

to

support

existing,

emerging,

and

futurerequirements.


12/28

Page10

Goal3: TheFCCshouldbuildonexistingprogramsandlinkprogramswhenpossibleinordertoexpand

broadbandaccessforhealthcare.

3.1.

Update

the

Rural

Health

Care

Program.

3.1.1. TheFCCshouldworktoexpandawarenessandexplorewhetherwirelesstechnologycanbesupportedintheRuralHealthCare

program.

ThenowconcludedRuralHealthCarePilotProgramhashelped

offsetthecostoftelecommunications,Internetaccess,andother

advancedservicesforcertainhealthcareproviders. The

Commissionwillbenefitgreatlyfromthelessonslearnedand

valuederivedfromtheoriginalPilotprojectsasitmovesforward

toreformtheRuralHealthCareProgram.

FCCshouldworktoexpandawarenessthroughoutreachand

promotetherangeofinnovativetechnologiesitfundstoitstarget

populations. TheFCCshouldcontinuetodesigntheprogramso

astoenablehealthcareproviderstousetechnologyflexiblyto

improvethedeliveryofhcare. TheFCCshouldconsidernewand

differentcombinationsofitsprogramsforusebyRuralHealth

CareProgramfacilitiessothattheymayachievesustainability

overtimeandprovidethemostfunctionalityatthelowestcost.

3.1.2. TheFCCshouldpermitconsortiumapplicationsfortheRuralHealth

Care

Program.

WhilethetraditionalRuralHealthCareProgrampermitsgroupsof

healthcareproviderstoapplyasaconsortium,aseparate

applicationisstillrequiredforeachhealthcareprovidersite. In

2006,theFCClaunchedtheRuralHealthCarePilotprogram,

whichallowsapplicantstoapplyfortheprogramasconsortiaof

healthcareproviders,withasingleapplicationforeach

consortium. Theconsortiumapproachgeneratedmanybenefits,

includinggreaterefficiencies,costsavings,andtelehealth

applications.

AsitconsidersvariousreformstotheRuralHealthCaresupport

mechanism,theFCCshouldallowgroupsofgeographically

dispersedsitestofileasingleconsortiumapplication. Such

applicationscouldyieldhigherbandwidthandlowerpricesfor

ruralproviderslinkingwithurbancarecentersforimproved

servicequality.


13/28

Page11

3.2. ModernizingtheLifelineProgramforBroadband.3.2.1. TheLifelineprogramshouldsupportfixedandmobilebroadband

services.

OnethirdofAmericansdonothavebroadbandathomeandtens

ofmillions

of

Americans

do

not

have

smartphones.

In

the

Lifeline

program,theFCChasadoptedagoalofensuringtheavailability

ofbroadbandserviceforlowincomeconsumers.

Tofurtherthatgoal,theFCCshouldcontinueonitspathto

reformtheLifelineprogram,whichstartswithapilotprogramto

supportfixedandmobilebroadbandin2012. Enablingmore

AmericanstohaveaccesstotheInternetathomeandgreater

mobileconnectivitycanfacilitateengagementwithhealthcare

providers,drivemHealthsolutions,andlowercosts.

3.2.2. AstheLifelineprogramtransitionstosupportbroadband,theFCCshouldaddhealthcaredeliveryasagoalfortheprogram.

TheLifelineprogramhastraditionallysubsidizedtelephone

serviceforlowincomeAmericans. Theprogramwilllauncha

broadbandpilotin2012thatwouldsubsidizebroadbandservice

(fixedandmobile)forlowincomeAmericans. Iftheprogram

transitionstosupportmobilebroadband,theFCCshouldconsider

addinghealthcaredeliveryasaprogramgoalandinfact,Lifeline

currentlyutilizesMedicaidparticipationasadeterminantfor

provingpovertyleveleligibility.

Mobilebroadband

and

smartphones

can

enable

amyriad

of

mHealthsolutionsthatcanhelpLifelineMedicaidbeneficiaries

havebetteraccesstohealthcare. ExtendingLifelinetoaimfor

healthcaredeliveryalsocreatesanopportunityfortheFCCto

partnerwithotheragenciessuchasHRSA,IHS,andCMStodeliver

mHealthsolutionstothosepopulationsthathavefewerresources

andexperiencegreaterhealthdisparities.


14/28

Page12

Goal4: TheFCCshouldcontinueeffortstoincreasecapacity,reliability,interoperability,andRFsafetyofmHealth

technologies.

4.1.

FCC

should

make

available

more

licensed

spectrum

for

mobile

broadband.

Additionallicensedmobilespectrumwillhelpmeetfutureoverall

spectrumdemandsandensurereliablemobilebroadbandconnectivity

forspectrumintensivehealthcareservicessuchaslivevideo,remote

monitoring,radiologicalimaging,andothermedicalapplications.

FCChasidentifiedfuturemobilebroadbandconstraintsandshouldfactor

intoitsfindingsspectrumdemandinghealthcaredatatransmission

includingtheanticipatedincreaseofmHealthproductsandservices.

Withtheanticipatedincreaseindemandforwirelessspectrum,theFCC

shouldevaluateimplementationplanstoaccommodateadditional

wirelessuseprojections.

4.2. FCCshouldworkwithinternationalcounterpartstoallocateandwhenneeded,harmonizespectrumforservices,suchasMedRadio.

TheU.S.isthefirstcountryintheworldtoallocatespectrumforMedical

BodyAreaNetworks(MBAN). FCCalreadyhasinitiateddiscussionswith

Mexicanregulatorsandotherinternationalcounterpartsontheneedfor

internationalharmonization

of

MedRadio

spectrum

to

encourage

the

proliferationoftheseservicesandproducts.Harmonizationofspectrum

formedicalusesacrossinternationalborderswillbothallowconsumers

tosafelyusedevicesacrossbordersandprovideforbettereconomiesof

scalefordeviceandradiomanufacturers.

4.3. FCCshouldsolicitinputfromthemedicalcommunitytoassess25yearneedstosupportmedicalimagingandvideocommunicationsgiven

futurehealthcareneeds,especiallywithregardtotheMedicareand

MedicaidEHRIncentiveProgramrequirements.

Transmissionof

medical

images

(e.g.

CT,

PET,

MRI,

ultrasound,

digital

angiography)usingdisksisabarriertoefficientandeffectivecare.

Patientsareburdenedwithrequestingimagedisksfromreferring

providersandmailingthefilestoconsultants.Healthcarefacilitiesare

importingdatafromhundredsofthousandsofpatientprovidedimage

disksannually.


15/28

Page13

NationalITinfrastructureshouldaccommodatecurrentandfuture

medicalimagetransmissionneedstoenablemoretimelyandreliable

healthcaredelivery. TheFCCcouldsolicitcommentfromthemedical

community,especiallytheAmericanCollegeofRadiologyandAmerican

CollegeofCardiologytobetterunderstandthebandwidthandclinicaluse

requirementsfor

transmission

of

medical

images.

4.4. FCCshouldencourageandlenditsexpertiseforthecreationandimplementationofwirelesstestbeds.

Testingandevaluatinginnovativewirelesshealthcaredevicesiscomplex

andexpensive,inpartduetothescarcityofcompletewirelesstest

environmentsandexpertise.Amoreeffectiveapproachtousing

spectrumfortestbedenvironmentsisneeded. TheFCCshouldfinalize

itsproposaltostreamlineitsexperimentallicensingprogram,including

licensingformedicaldeviceexperimentation,whichwillenableindustry

toform

wireless

test

beds

and

publicly

share

their

results.

Access

to

FCC

expertiseforguidanceisalsonecessary(e.g.,beyondconsultation

receivedviatheOETLaboratoryDivisionKnowledgeDatabase).

Specifically,werecommendthattheFCCencourageandlendits

expertisetothefollowinginitiatives:

Creationofnationalcenterswithequipment,expertise,licenses,andsupportstaff.

Identificationoftoolsandconsensusstandardstomonitorandassesstheperformanceofwirelesstechnologiesinhealthcare

environments.

Easieraccesstospectrumorrulesforhealthcarethatfeedthequestforinteroperability(e.g.,separatemedicalspectrumwithmore

capability,rulesformoreprotectionsoncriticalcarespectrum,

emergencysituationscommunications).

Encouragementforinnovationoftechnologyandothertoolssuchasstandardsorpublications.

Encouragementofnewertechnology(e.g.,cognitiveradio)andapplicationsthatarebuiltonariskmanagementapproach.

4.5. FCCshouldmodifySARtestingrequirementstoaccountforintermittentdatatransferinconvergedmedicaldevices.Medicaldeviceswhichutilizeintermittentdatareportingcapabilities(i.e.,

transmitinfrequently)shouldbeaddressedintheupcomingRFsafety

proceeding. TheRFexposurelevelsforthesedevicesshouldbeassessed

withinthecontextoftheirusage.


16/28

Page14

4.6. FCCshouldevaluateandmakerecommendationstoaddresstheissuesofaffordableconnectivityandcompatibilitytosimplifytheinstallation

oftelehealthdevicesinhomeenvironmentswithalternativeservices

suchasVoIP.

Manymedical

devices

have

relied

upon

modem

connections

over

the

POTSnetworkforinexpensivetransmissionofhealthrelatedinformation.

AsmoreconsumersmigratetoVoIP,broadband,orwirelessproviders,

thecostandcomplexityincreasesforinstallingandmaintaininghome

healthmonitoringequipment.

Goal5: Industryshouldsupportcontinuedinvestment,innovation,andjobcreationinthegrowingmobile

healthsector.

5.1. IndustryshouldcontinuetodevelopanddeployinnovativecosteffectiveandclinicallyrelevantmHealthandeCaresolutions.

ThepassageoftheHITECHActandthePatientProtectionandAffordable

CareActcombinedwiththegeneralavailabilityofbroadbandandthe

adoptionofuserfriendlyconsumerelectronicdeviceslikesmartphones

andtabletsPCshasinvigoratedmHealthinvestmentandinnovation.

Investmentinmedicaldevices,healthsensors,andsoftwareapplications

thatareincreasinglyusingwirelessfunctionalitytoimprovehealthcare

access

and

delivery

is

growing

at

a

record

pace

in

2012

with

over

$750M

inventurecapitalinvestments.ix

Industryshouldcontinuetotakeadvantageofthisunprecedented

convergenceofmedicalscience,communicationstechnology,and

healthcarefinancialreform.

5.2. Industryshouldadoptstandardsbasedtechnologiestotransmitauthenticatedmessagesandencryptedhealthinformation.

Peragencyrecommendation2.7,Industryshouldpursueahealth

communication

infrastructure

as

ubiquitous

and

convenient

as

e

mail

usingsimple,secure,scalable,standardsbasedtechnologies.


17/28

Page15

5.3. Industryshouldprovideaccessanddocumentationforsecureandtrustedapplicationinterfaces(APIs)forhealthdataservicesuchas

certifiedEHRs,EHRmodules,andhealthinformationexchanges.

Thecost,risk,andongoingmaintenanceofintegratingwith3rd

party

devicesand

software

solutions

are

barriers

to

the

investment

and

adoptionofclinicallyandoperationallyeffectivehealthsolutions.

Industry(deviceandsoftwarevendors)shouldencouragetrusted3rd

partyhealthdataintegrationsbyprovidingaccessanddocumentationto

simple,secure,scalable,standardsbasedAPIs.

5.4. Industryshouldseekcollaborativeopportunitiesforinformalandformalprivatepublicpartnershipswithfederalpartners.

ThemHealthTaskForceservesasamodelexampleofindustry,

academic,public,andprivatesectorcollaboration. Weencourageother

federalagencies

to

assemble

relevant

stakeholders

for

information

and

ideaexchange.


18/28

Page16

Conclusions

TheFCCplaysanessentialroleinenablingthecountryshealthinformation

technologies,specificallymobilehealth,wirelesshealth,andeCaresolutions. Criticalto

thesuccessofanimprovedhealthcaresystemisaccess,availability,interoperabilityand

capacityofwiredandwirelessservicesthataredefiningthefuturedeliveryofhealthcare.

ThemHealthtaskforcehaslaidouttheabovefindingsandrecommendationswithgoals

thatareactionablebytheFCC,otherfederalagencies,andindustryalike. Itisourintent

tocontinuetheworkstartedbytheTaskForceandhelpimprovebestpracticesforcare

deliverythroughenhancedcommunicationandappropriatefinancialincentives.

ThemembersofthemHealthTaskForcewouldliketothankFCCChairmanJulius

GenachowskiandtheFCCfortheiropennessandcontinuedleadershipinthisevolving

but

nonetheless

important

area.


19/28

Page17

Endnotes

iFCCChairmanGenachowskiHostsmHealthSummittoFosterInnovationinWireless

HealthTechnology:

http://bit.ly/FCCmHealthSummit

iiTheFCCNationalBroadbandPlandefineseCareas,Theelectronicexchangeof

informationdata,imagesandvideotoaidinthepracticeofmedicineandadvanced

analytics.Encompassestechnologiesthatenablevideoconsultation,remotemonitoring

andimagetransmission(storeandforward)overfixedormobilenetworks.atPage

218.iiiMeasuringthePerformanceoftheU.S.HealthCareSystem

ChristopherJ.L.Murray,M.D.,D.Phil.,andJulioFrenk,M.D.,Ph.D.,M.P.H.

NEnglJMed2010;362:9899January14,2010ivWorldhealthstatistics2011.Geneva:WorldHealthOrganization.

vBestCareatLowerCost:ThePathtoContinuouslyLearningHealthCareinAmerica,

September2012,

Mark

Smith,

Robert

Saunders,

Leigh

Stuckhardt,

J.

Michael

McGinnis,

Editors;CommitteeontheLearningHealthCareSysteminAmerica;Instituteof

MedicineatS8.viHealthcareunwired,PricewaterhouseCoopersHealthResearchInstitute,Sept.2010:

http://www.healthcareitnews.com/sites/healthcareitnews.com/files/resource

media/pdf/pwc_healthcare_unwired.pdf.vii

IncludingtheFoodandDrugAdministration(FDA),theOfficeoftheNational

CoordinatorforHealthInformationTechnology(ONC),theCenterforMedicareand

MedicaidServices(CMS),theHealthResourcesandServicesAdministration(HRSA),

NationalInstitutesofHealth(NIH).viii

As

noted

in

the

Eighth

Broadband

Progress

Report,

the

FCC

continues

to

assess

broadbanddeploymentusingaspeedtierthatapproximatesthe4Mbps/1Mbpsspeed

benchmark.However,theFCCreliesondatafromNTIA'sStateBroadbandInitiative

(SBI),andtheSBIdataarecollectedbypredeterminedspeedtiers,noneofwhichare4

Mbps/1Mbps. TheclosesttiertotheFCC'sspeedbenchmarkliesat3Mbpsdownload

and768kbpsuploadspeeds(3Mbps/768kbps). TheFCCusesthe3Mbps/768kbpstier

asaproxyforthe4Mbps/1Mbpsspeedbenchmarkinmakingitsstatutoryassessment

ofdeployment.ixRockHealthhealthITfundingdatabase:http://rockhealth.com/resources/funding

database/


20/28

Page18

AppendixI Barriers&Opportunities

ThefollowingsectionwasdevelopedbythemHealthTaskForcetostimulate,collect,

andorganizediscussionsaroundkeysubjectareas.Thecontentofthissectionis

broaderthantherecommendationinthefinalreport.Itisincludedheretodocument

thework

of

the

Task

Force

and

to

serve

as

abasis

for

future

activity.

i. WirelessMedicalDeviceConnectivity1. Networktechnologyselection

a. Arethemostappropriatewirelesstechnologiesbeingusedforthevariousmedicalusecases?Forexample:

i. IsWLANthecorrecttechnologyforhospitals? Forthehome?Office?

ii. Performancechallengesfordeviceroamingwithinhospitalsiii. Resolvingdevicelocationinhospitals

2. Devicecoexistencea. Howisthehighconcentrationofwirelessdevicesimpacting

communicationreliability?Whatwilllongtermimpactbewiththe

projectedincreaseofdevices?

3. SARsTestinga. SARstestingfordevicesthatoperateintermittently.

4. Wirelesstestbedsa. Availabilityofwirelesstestbedstoimproveresearch,developmentand

deployment.

ii. RuralProviderAccesstoBroadbandCoverage1. FCCRuralHealthcarePilotProgram2. Leveragebothwiredtechnology&commercialwirelessnetworks

iii. PatientAccesstoBroadbandCoverageanddevices1. Elderly&lowincome2. Universalaccessformobilehealthcareservices

iv. M2Maccesstodevices,software&services


21/28

Page19

1. ElectronicInterfacesforsystemcommunicationbetweendevices,software&services

2. Remotedevice,software&servicesmanagementa. Complexityofconnectingtelehealthsystemsinhomes

v. PatientSafety,PrivacyandSecurity1. Patientsafety2. Securecommunications3. Patientidentification

vi. Ubiquitousmobilespectrum1. Travelingpatients

a. Internationalb. Transitionsofcare home/ambulance/hospitalonlyc. Clarificationonusecasesd. Pathtocommercialization

vii. PatientMedicalDevicesandmobilemedicalspectrum1. MBAN2. WMTS3. MedRadio

viii. SecureMessaging NationwideHealthInformationNetwork(NHIN)1. Securehealthmessagingadoption2. ONCProjectDirect3. Patient/Providermessaging4. Provider/Providermessagingacrossdeliverynetworks

ix. Reimbursement1. ReimbursementforcostreducingeCareservices2. ONCincludemHealthandotherhealthITservicesinMeaningfulUse


22/28

Page20

x. InterstateLicensingforProviders1. Physicians2. Nurses

xi. Administrative1. IndustryandintraagencyhealthITandmHealthSummitmeetings

xii. DefinecommonnomenclatureacrossFCC/ONC/FDA/CMS


23/28

Page21

mHealthTaskForceCoChairs

JulianGoldman

MedicalDirectorofBiomedicalEngineering,PartnersHealthcareSystem

JulianM.Goldman,MDisMedicalDirectorofBiomedicalEngineering

forPartnersHealthCare,apracticinganesthesiologistatthe

MassachusettsGeneralHospital,andDirectoroftheProgramon

MedicalDeviceInteroperabilityatMGHandCIMIT(Centerfor

IntegrationofMedicineandInnovativeTechnology).Dr.Goldman

foundedtheMedicalDevice"PlugandPlay"(MDPnP)

Interoperabilityresearchprogramin2004toadvanceinnovationin

patientsafetyandclinicalcarethroughinteroperability.Theprogram

wastherecipientofthe2007CIMITEdwardMKennedyawardforHealthcare

Innovation.Dr.

Goldman

completed

clinical

training

and

afellowship

in

medical

device

informaticsattheUniversityofColoradoandservedasaVisitingScholarintheFDA

MedicalDeviceFellowshipProgram.HeisChairofISOTechnicalCommittee121,Chair

oftheUseCaseWorkingGroupoftheContinuaHealthAlliance,UserViceChairofASTM

CommitteeF29,andservedontheNSFCISEAdvisoryCommitteeandCDCNCPHIBoard.

HisawardsincludetheAAMIFoundation/InstituteforTechnologyinHealthCareClinical

ApplicationAward,theInternationalCouncilonSystemsEngineeringPioneerAward,

andtheAmericanCollegeofClinicalEngineeringawardforProfessionalAchievementin

Technology..

RobertJarrin

SeniorDirector

of

Government

Affairs,

Qualcomm

Corporation

RobertJarrinisaSeniorDirectorofGovernmentAffairsforQualcomm

Incorporated.HeisbasedinWashington,D.C.andrepresents

QualcommonU.S.domesticregulatorymattersrelatingtowireless

healthandlifesciences. Jarrinsareasofresponsibilityinclude

wirelesshealthpolicy,FDAregulatoryoversightofconvergedmedical

devices,healthcarelegislativeaffairs,CMStelehealthreimbursement

andtheregulationofhealthinformationtechnology.

Externally,Jarrin

is

amember

of

the

mHIMSS

Advisory

Council,

leads

the

American

TelemedicineAssociation(ATA)PolicyATeamonTelehealthandMeaningfulUse,isthe

U.S.ChairfortheEuropeanAmericanBusinessCouncil(EABC)eHealthPolicyGroup,

servesontheScientificAdvisoryBoardofMedicalAutomation,hasservedasCoChairof

theU.S.PolicyWorkingGroupfortheContinuaHealthAllianceandisseatedonthe

BoardofDirectorsforVidaSeniorCenters,theoldestLatinononprofitorganizationin

theDistrictofColumbia.


24/28

Page22

DouglasTrauner

ChiefExecutiveOfficer,HealthAnalyticServices,Inc.(TheCarrot.com)

Mr.TraunerfoundedHealthwhAnalyticServices,Inc.in2007and

launchedtheoutpatientcarecoordinationplatformofTheCarrot.com

in2008.

TheCarrot.com

is

an

award

winning,

mobile

and

online

servicethathelpshealthcareproviderscoordinatedischargeplanning,

chroniccareservicesandpatientselfmanagement. Itsclinically

validatedplatformofferssolutionsforreducingreadmissions,

managingpostdischargecareandenhancingwellness.Mr.Trauneris

afrequentspeakeronthesubjectofpatientengagementandprivacy.

HepreviouslycofoundedPMSquared,Inc.,ahealthcareinformationcompany

providingfinancialandactuarialservices,whichwasacquiredbyUnitedHealthcare.Mr.

TraunerhasanengineeringdegreefromtheUniversityofCaliforniaatSanDiego.


25/28

Page23

mHealthTaskForceParticipantList

CoChairs,mHealthTaskForce

JulianM.

Goldman,

MD

AttendingAnesthesiologist,

MassachusettsGeneralHospitalMedical;

Director,

PartnersHealthCareBiomedical;

EngineeringDirector,

CIMITProgramonInteroperability(MD

PnP)

RobertJarrin

SeniorDirector,GovernmentAffairs

QualcommIncorporated

DouglasTrauner

ChiefExecutiveOfficer

HealthAnalyticServices,Inc.

(TheCarrot.com)

Members,mHealthTaskForce

DaveArney

LeadEngineer

MedicalDevice"PlugandPlay"(MDPnP)

InteroperabilityProgram

EvanBeard

CoFounder

Gridtech

AdamDarkins,MD,MPHM

ChiefConsultantforTelehealthServices

U.S.DepartmentofVeteransAffairs

KentDicks

CEO,Chairman,

and

Founder

MedApps

JeffreyH.Dygert

ExecutiveDirector,PublicPolicy

AT&TServicesInc.

RichardM.Eaton

DirectorofIndustryPrograms

MedicalImaging

&

Technology

Alliance

(MITA)

HankFanberg

Director,TechnologyAdvocacy

CHRISTUSHealth

CharlesS.Farlow

SeniorProgramManager

CardiacRhythmDiseaseManagement

Medtronic,Inc.

YaelHarris,PhD,MHSDirector,OfficeofHealthITandQuality

HealthResourcesandServices

Administration

DepartmentofHealthandHumanServices

DavidHankin

ChiefExecutiveOfficer

AlfredMannFoundationforScientific

Research

AnandK

Iyer

PresidentandChiefOperatingOfficer

WellDocInc.

JonathanJavitt,MD,MPH

ChiefExecutiveOfficer&ViceChairman

Telcare

RichardJ.Katz,MD

Director,DivisionofCardiology

GeorgeWashingtonUniversitySchoolof

Medicine

MohitKaushal,MD

ChiefStrategyOfficerandExecutiveVice

PresidentofBusinessDevelopment

WestHealth


26/28

Page24

AndreaLenco

Research&GrantWritingAssistant

MedicalDevice"PlugandPlay"(MDPnP)

InteroperabilityProgram

MassachusettsGeneralHospital

LindaMagno

DirectoroftheMedicareDemonstrations

Group

OfficeofResearch,Developmentand

Information

CentersforMedicareandMedicaidServices

TomMaguire

Director

PublicPolicy

VerizonCommunications

TomMartin

Manager

mHIMSS

KerryMcDermott,MPH

SeniorPolicyDirector

WestHealthPolicyCenter

DavidMuntz

PrincipalDeputyNationalCoordinator

Office

of

the

National

Coordinator

for

HealthInformationTechnology

U.S.DepartmentofHealthandHuman

Services

WendyJ.Nilsen,Ph.D.

HealthScientistAdministrator

OfficeofBehavioralandSocialSciences

Research

NationalInstitutesofHealth

BakulPatel,MSEE,MBA

SeniorPolicy

Advisor

OfficeoftheCenterDirector

CenterforDevicesandRadiologicalHealth

FoodandDrugAdministration

AndySallee

DirectorofSales

MedApps

AnandSampath

ExecutiveVicePresident

Masimo

JosephM.Smith,MD,PhD

ChiefMedicalandChiefScienceOfficerWestHealth

MarkVickberg

Engineer

MayoClinic

DaveWhitlinger

ExecutiveDirector

NewYorkeHealthCollaborative

DaleC.

Wiggins

GeneralManager

PhilipsResearchNorthAmerica;

VicePresident

RoyalPhilipsElectronics

WilliamF.Wallace

ProjectDirector

USIgnite

FelasfaWodajo,MD

Editor,

Member

founding

team,

iMedicalApps;

MedicalDirector,MusculoskeletalOncology

VirginiaHospitalCenter


27/28

Page25


28/28

mHealthTaskForceFindingsandRecommendations

September24,2012

Documents

m Health Recommendations