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Wireless Health 2014 Conference Workshop. Speakers include Sara Zellner, PhD, Health Data Consortium, and Lauren Ellis, JD, Health Data Consortium.
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WLSACONVERGENCE SUMMIT
UNLOCKING THE POTENTIAL OF OPEN HEALTH DATA IN WIRELESS HEALTH
LAUREN ELLIS, HEALTH DATA CONSORTIUM
SARA ZELLNER, HEALTH DATA CONSORTIUM
Unlocking the Potential of Open Health Data in
Wireless Health
Lauren Ellis, Director of Policy and Government AffairsSara Zellner, Director of Programs
Health Data Consortium
The purpose of this workshop is to provide news and information on legal & regulatory issues. All content provided is for informational purposes only, and should not be considered legal advice. The transmission of information from this presentation does not establish an attorney-client relationship with the participant. The participant should not act on the information contained in any of the materials or in the presentation without first consulting retained legal counsel. If you desire legal advice for a particular situation, you should consult an attorney.
Disclaimer
Goals for the Workshop
Today, we will:• Introduce the Health Data Consortium (HDC)• Describe the what, where, whys of open health data and
wireless health• Delve into legal and regulatory aspects• Talk through open health data case studies in wireless
health• Work through barriers and solutions to open health data
use
HDC: The Snapshot
Health Data Consortium
• 501(c)3, Public Private Partnership
• Washington DC
• Advocacy and Membership
• Foundations, businesses, and government as well as data scientists, entrepreneurs, innovators, and patients
Organization:
Form:
HQ:
Role:
Membership
A Sampling of HDC Organizational Members
Health Datapalooza is our flagship event
TODD PARK U.S. Chief Technology Officer
KATHLEEN SEBELIUSSecretary Health & Human Services
JONATHAN BUSHCo-Founder, athenahealth
Health Data
Better care
Consumer experience
Lower costs
Care coordination
Informed patients
Targeted interventions
Comparative effectiveness
Fraud detection
Elimination of waste
Better research
Reduction in mistakes
Resource optimizations
Innovation
Cultural resistance
Policy limitations
Privacy concerns
IP and Competitiveness
Technology limitations
Lack of standards
Cost and resources
Silos, Stovepipes, Islands
Competing priorities
Liability concerns
Health data enables many benefits …and will improve outcomes ...
but there are many barriers to overcome …
Why doesn’t health care capture the full promise of health
data today? In understanding the opportunities and
barriers, we better understand where to focus our efforts
We have a diverse group of Health Data Stakeholders
• Smaller and larger organizations.
• Public and Private
• Essential voices from the patient to physicians to academia.
• All vital to the discussion.
• Information producers, information consumers, and tools.
While HHS and other parties are positioned to address some
of these barriers, HDC is uniquely positioned as the neutral
public private partnership to engage all the stakeholders in
change
04/13/2023 10Draft | HDC Confidential
Open Health Data: Focusing initially on government, HDC will advocate for release of deidentified data at all levels in order to improve health outcomes, inform choices, increase transparency, and drive accountability across the system. We will promote the operational “readiness” of the data – it must be documented, supported, and continually improved to ensure its safe and broad use.
Enable and promote data sharing across the health system: HDC will promote responsible health data sharing policies, standards, practices, collaborations, and reforms that improve health outcomes, catalyze innovation and facilitate research, and drive efficiencies. This effort will require a balance between the missions of the public and private sectors – a balance we believe is achievable through cooperation and partnering among the many stakeholder groups.
Promote a human centered health system, powered by health data: It’s about better health and a more personal health care experience. HDC will promote a vision for health data exchange that elevates the role of each of us, empowers patients with information and control of their data, advocates for secure information sharing policies, and seeks to create a robust patient information framework to improve patient outcomes, and the healthcare system.
Free the data
Use the data
Improve health
To overcome these barriers, we developed three
foundational strategies which we believe will transform the
use of health data and accelerate the benefits dramatically
Open Health Data: The Overview
What is open health data?
Table stakes: Publicly available data that can be accessed, downloaded, or utilized without further requirements or stipulations of use by the data holder
Ideally: Paths to broad arrays of data, linked and de-identified, public and private, traditionally “health” and health-related. Accessible and available for research, policy work, decision making, etc.
Why open health data?• Research has documented the benefits of opening
health data in the U.S. healthcare system
• McKinsey & Co.: Open Data: Unlocking Innovation and Performance with Liquid Information (2012)
• “We estimate the use of open and proprietary data in health care could help generate value of $300 billion to $450 billion per year in the United States. Most of this value comes in the form of cost savings to providers, payers, and patients.”
• Capgemini Consulting: The Open Data Economy Unlocking Economic Value by Opening Government and Public Data (2013)
• “Though the savings cannot be solely attributed to opening up data, the efficiency of hospitals and exchange of best practices has had a significant effect on hospital functioning and public health.”
Where Can You Find Open Health Data Sets?
HDC Health Data All-Starsallstars.healthdataconsortium.org
Health Data All Stars: State Health Data Portals
HealthData.gov
YODA Project (yoda.yale.edu)
DataHub (datahub.io)
The World Bank (datacatalog.worldbank.org/?Topics=Health)
The Demographic and Health Surveys (http://www.dhsprogram.com/)
Regulatory and Legal Issues with
Health Data Usage
• Wireless Technology Medical Devices
• Mobile Medical Applications (“Apps”)
• HIPAA
• State Privacy Laws
Legal & Regulatory Issues
Wireless Technology Medical Devices
Wireless Technology Medical Devices
Wireless Medical Devices, whether implanted or worn on the body must be tested for conformance to various technical standards and authorized by the FCC before the device is imported, marketed or operated in the U.S.
FCC Certification
• Equipment Marketing and Authorization
• Importation
• Enforcement Action
• Equipment Authorization Process
• Waivers
• Rulemaking
• International Regulations
FCC Regulation of Wireless Devices
FDA regulates the marketing of all medical devices sold or imported in the U.S.
Medical Device: “an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar related article, including a component part or accessory that is intended for the use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment or prevention of diseases in man or other animals or intended to affect the structure or any function of the body of man or other animals.”
FDA Regulation of Wireless Devices
August 2013: Guidance on Wireless Medical Devices
• Device Classification• Wireless Medical Device Regulation• Recommendations for Devices Incorporating Wireless
Technology
FDA Regulation of Wireless Devices
Class I: Most devices may be marketed without FDA permission but still subject to other FDA requirements
Device Classification
Class II: Device may be marketed after a pre-market notification where the FDA must determine that the device is “substantially equivalent” with respect to the safety and effectiveness of another device that is lawfully on the market.
Device Classification
Class III: Novel, high risk devices for which the FDA requires proof of the safety and effectiveness based on clinical trials. Device must be approved via pre-market approval (PMA)
Device Classification
Regardless of the device classification—
• Establishment Registration• Medical Device Listing• Devices including software
Wireless Medical Device Regulation
• Selection & Performance of Wireless Technology• Wireless Quality of Service• Wireless Co-existence• Security of Wireless Signals & Data• Electromagnetic Compatibility (EMC)• Information for Proper Set-up & Operation• Considerations for Maintenance
Recommendations for Devices Incorporating Wireless Technology
Mobile Medical Applications
September 2013: Guidance on Mobile Medical Applications (“Apps”)
Focus: Mobile Medical Apps that create a greater risk to patients if the application does not work as intended and applications that cause smartphones and other mobile platforms to impact the functionality or performance of traditional medical devices
Mobile Medical Applications
Mobile Platform: Commercial off-the-shelf computing platforms with or without wireless connectivity that are handheld in nature
Mobile Medical Apps—Definitions
Mobile Application: Software applications that can run on a mobile platform or a web-based software application that is tailored to a mobile platform but run on a server
Mobile Medical Apps—Definitions
Mobile Medical Application: Mobile application that meets the definition of “device” under the Food, Drug & Cosmetic Act and either is intended to be used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device
Mobile Medical Apps—Definitions
Class I: Mobile apps that are an extension of one or more medical devices by connecting to such devices for purposes of controlling the devices or displaying, storing, analyzing or transmitting patient-specific medical device data
What will the FDA Regulate?
What will the FDA Regulate?
Class II: Mobile apps that transform the mobile platform into a regulated medical device by using attachments, display screens or sensors or by including functionalities similar to those of current regulated medical devices
Class III: Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis or treatment recommendations
What will the FDA Regulate?
• Establishment Registration• Medical Device Listing• Labeling • Investigational Device Exemption Requirements• Pre-market submission for approval/clearance
Device Regulatory Requirements
Health Insurance Portability and Accountability Act
(HIPAA)
• Is the information Protected Health Information (PHI)?
• Is a covered entity involved?
• Does a business associate relationship exist with a covered entity?
Privacy Considerations—HIPAA
Information that is maintained or transmitted in any form whether electronic or not that relates to—
• A past, present, or future physical or mental health condition;
• Provision of health care or• Past, present or future payment for the provision of
health care to an individual
What is PHI?
• Information concerning a person who has been deceased for over 50 years
• Employment records held by a Covered Entity in its role as an employer
• De-identified information
What is NOT PHI?
De-identified Information
• Health information that does not identify an individual and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual
A health plan, health care clearinghouse or health care provider who transmits any health information in electronic form in connection with a covered transaction
Is a Covered Entity involved?
A person who either creates, receives, maintains or transmits protected health information (PHI) for a regulated activity on behalf of a covered entity or provides legal, actuarial, accounting, consulting, data aggregation, management, administrative accreditation or financial services to a covered entity where the services involve the disclosure of PHI.
Does a business associate relationship exist with a covered entity?
Generally, you cannot use and disclose PHI without an authorization except for—
• Treatment• Payment• Healthcare operations
• Exceptions
HIPAA Privacy Rule
Data sets can be released without patient authorization so long as the data recipient signs a data use agreement containing specified restrictions and privacy protections
HIPAA Privacy Rule—Limited Data Sets
• Applies to Electronic Protected Health Information (EPHI)
• Administrative, Technical and Physical Safeguards
• Risk Assessment Required
HIPAA Security Rule
• Non-covered entities
• De-identified data
HIPAA & Open Health Data
State Privacy Laws
• Common law and/or statutory right to privacy
• HIPAA Privacy Rule establishes a floor of federal privacy protections and rights to individuals
• State laws contrary to HIPAA Privacy Rule
State Privacy Laws
Health Data & Wireless Health
• Review Terms of Use
• HIPAA
• State Privacy laws
Open Health Dataset Checklist—
Case Study #1:
• Founded in 2008 by two ER doctors in Colorado• Addresses health systems needs:
1. “Based on my symptoms, what might I have?”2. “What treatments or medications are appropriate to
treat this condition?”3. “How urgently do I need care?”4. “Where can I find care?”
• Provides symptom-to-provider workflow for addressing a user’s health situation
Introduction: iTriage Health
• iTriage uses open data to create symptoms checker and provider / resource directoryo 2010: integrated 7,500 community health centers from HRSA and the
National Provider Identifier physician database.o 2011: integrated mental health and substance abuse centers from
Substance Abuse and Mental Health Services Administration.o 2013: integrated CDC datasets into symptom checker; introduced CMS
home health services listings; and integrated the Health Resources and Services Administration (HRSA) TXT4Tots library.
o 2014: using data from the standards-based HHS Direct Project to launch iTriage Connect, which provides direct, secure patient-to-provider connectivity in mobile app.
iTriage Using Open Data
Product Walkthrough
Product Walkthrough (2)
Product Walkthrough (3)
Opportunities• Empowering consumers in their decision-making for their
health situation and health care options• Reducing costly health care spending by limiting emergency
room use and providing alternative care providers nearby
Challenges• Building credibility of the brand in the information provided
on conditions / drugs and the recommendations given• Security of personal health data hosted in the mobile app
Opportunities/Challenges
• 12 million+ downloads through iTunes & Google Play store
• 4.5 / 5 star rating for app on both platforms• Acquired by Aetna in 2011• 100+ employees now, after acquisition
Outcomes
Case Study #2:
The Quantified Self is a movement to incorporate technology into data acquisition on aspects of a person’s daily life in terms of inputs (e.g. food consumed, quality of surrounding air), states (e.g. mood, arousal, blood oxygen levels, heart rate), and performance (mental and physical).…Other names for using self-tracking data to improve daily functioning are “self-tracking”, “auto-analytics”, “body hacking” and “self-quantifying.”
– Wikipedia
What is the “Quantified Self”?
What is the “Quantified Self”?
But what do we do with this data?
What is the “Quantified Self”?
• Steps with Balance® Rewards program allows users to connect fitness trackers to their app so Walgreens customers can receive reward points – to be transformed dollars saved in Walgreens stores.
Walgreens Balance® Rewards
Walgreens Balance® Rewards
Walgreens Balance® Rewards
Walgreens Balance® Rewards
Walgreens Balance® Rewards
• Walgreens’ role evolving from a consumer health company to “an integrated health systems company”
• 8,200 pharmacies• 400 in-store clinics• 600 work-site health clinics
Beyond Pharmacies
• Walgreens is one of the first companies to utilize QS data
• Walgreens collects health information in one place• QS data• Prescription data• Purchase data• Health services and operations data
Opportunities
• What if self-tracking is just a “fad”?• How will Walgreens keep the data secure?• Will people want to give them their data?• How will Walgreens make sense of the data?
Risks & Challenges
• Walgreens' program is very new, so not much to report
• However, it's not only a novel use of wireless health tech, but it's a different perspective on ways data can be "open" to benefit the greater good of the patient
Outcomes
Discussion:Identifying and
Overcoming Barriers to Open Health Data Use
Interactive Breakout and Discussion
• Identify challenges your organizations face in using open health data• Internal • External
Interactive Breakout and Discussion
• Brainstorm solutions to address barriers and challenges• What resources would you require?• What programs (internal or external)
might accelerate the use of open health data?
The Future… Wireless Health with Open Health Data
What if we could answer these
questions?
What if we could integrate better data and information into health
and health systems?
What if YOU had this information?
What children are at real risk?
Decisions at the point of care, patient monitoring
Where are our most vulnerable populations and where must we focus our resources?
Which patients require interventions right now to avoid excessive future medical care?
Integrating all relevant information into case files
What doctors and hospitals are better suited for treatment?
How do environmental and social factors correlate to better health outcomes?
Better interventions What treatment options are broadly available? What do they cost? What are the pros/cons?
Thank you!
Lauren: lellis@healthdataconsortium.orgSara: szellner@healthdataconsortium.org
WLSACONVERGENCE SUMMIT
www.wirelesshealth2014.org
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