Doctors 2.0 and You 2015 - The Law of Wearables - Professor Nicolas Terry

5th Edition – Paris -- June 4-5, 2015

Nicolas Terry

Executive Director of the Hall Center for Law and Health

Indiana University Robert H. McKinney School of Law

The Law of Wearables


Presentation Goals

1.Explain Why Wearables Are Causing Regulatory Turbulence/Disruption in the US

2.Identify Emerging Legal Issues or Questions about Wearables


Regulation of Professional Healthcare Space

• Professional Monopoly of

Practice of Medicine

• Medical Devices

• Professional Data Custodians

• Clinical Trials

• Wellness/Fitness

• Consumer Platforms

& Apps

• Personal Data Curation

• Crowdsourcing

Regulation of Consumer

Healthcare Space




& Apps

• Personal ata Curation

• Crowdsourcing

Regulation of Professional Healthcare Space

• Professional Monopoly of

Practice of Medicine

• Medical Devices

• Professional Data Custodians

• Clinical Trials



& Apps


• Crowdsourcing

Regulation of Consumer

Healthcare Space


Business Disruption

• Professional Monopoly ofPractice of Medicine

• Medical Devices

• Professional Data Curation

• Clinical Trials


• Consumer Platforms& Apps


• Crowdsourcing


• Professional Monopoly ofPractice of Medicine

• Medical Devices

• Professional Data Curation

• Clinical Trials


• Consumer Platforms& Apps


• Crowdsourcing

Regulatory Disruption


Fitness

WellnessCondition

Management

Monitoring

Diagnostics

Communication

& Alerts

Fashion

Clinical

Trials

Social Media

Internet of Things


How Effective Is Your Wearable?

• Does your wearable ACTUALLY do what its developer says it does?

• How high is the evidence basis for diagnostic, etc. claims?


Is Your WearableCoercive/Discriminatory?• Cohorts most likely to adopt wearables have

good health determinants, digital and health literacy.

• What of the others?

• Will NOT having a wearable adversely affect health?

• How far can health & life insurers or employers go in MAKING us adopt wearables?

• If health & life insurers or employers gain access to individual wearable data will they try to abandon community rating?


Is Your Wearable a Medical Device?• FDA: When Are Wearables Regulated As Medical

Devices?

• “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 currently regulated medical devices”

• “Mobile apps that become a regulated medical device (software) by performing patient-specific analysis and providing patient-specific diagnosis, or treatment recommendations”

• Are Platforms or App Stores Regulated? Should They Be?


Is Your Wearable a Doctor?

• Do wearables challenge the traditional professional monopoly of healthcare?

• Physician licensure and regulation: When do diagnostic devices/services cross the line into the “practice of medicine”?

• Quality & safety?

• What is the app “standard of care”?


Do You Trust Your Wearable With Data?

• “Sousveillance”

• In US Most mHealth Apps and Wearables Fall OUTSIDE of HIPAA Health Data Protection Model

• 2015 FTC ‘Internet of Things’ favoring self-regulation

• Cf. EU Art. 29 Working Party Opinion 8/2014 on IoT able to leverage stronger baseline protections such as data minimization

• Surprising salience of “App Store” rules, including privacy policies

https://developer.apple.com/app-store/review/guidelines/#healthkit


What Will You Tell Your Patients? A Doctor’s 4 Stages of Wearable Grief

1.Tolerating Patients with Apps and Data

2.Approving Patient-Chosen Apps

3.Recommending Apps

4. Prescribing Apps

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healthcare provider. BlueStar gives you personalized, real-time guidance driven by your treatment plan.

BlueStar also helps you keep track of your blood glucose numbers, medications, diet and exercise all in one place and access them across all of your devices. With BlueStar, you can share your progress with your healthcare provider and better understand your diabetes.


(How) Will We Regulate Clinical Trials?

• Will Wearable Crowdsourcing Become the New Normal?

• Trial Design and Demographic Skew?

• Are the new Consent Models Adequate?

• Are they Actually an Improvement?


Will Your Wearable Harm/Kill You? • Literally. Products can be defective and

dangerous.

• We have yet to see a legal action based on a wearable recommending OVER or UNDER exercise, or "Exercise Addiction” but…

• Once your wearable is connected to IoT how should it react to your risky behaviors?

• Particularly decisions you make that are adverse to other wearable users or population health norms?


The Magic Kingdom of Health

• Teacher and guide (to app and “Kingdom”) reduces digital and health literacy

• Secure identification

• Communicated alerts

• Automated emergency services

• Coordination of care

• Reduced ambiguity as patients handed-off between providers

• Personalization of the healthcare experience


The Health ‘Selfie’


Mail: [email protected]: @nicolasterryPodcast: TWIHL.com

Doctors 2.0 and You 2015 - The Law of Wearables - Professor Nicolas Terry

Healthcare

Transcript of Doctors 2.0 and You 2015 - The Law of Wearables - Professor Nicolas Terry