WH2014 Workshop: Health Data Consortium

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?

Zellner, Sara

I may just show the datasets live on the web to make the session more interactive

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.


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)


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 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


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?


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


• 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”?


But what do we do with this data?


• 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® Rewardshttp://walgreens.com/steps

http://walgreens.com/steps



Amy Chang



• 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: [email protected]: [email protected]

WLSACONVERGENCE SUMMIT

www.wirelesshealth2014.org