Does Wearable Tech Give Away Your Quantifiable Self? FDA Medical Device, HIPAA Privacy and Security, and Legal Issues Over Who Owns Your Data

Wearable health technology is here, creating new legal and regulatory questions about who owns the data, whether HIPAA applies and protects the privacy of your quantifiable self. DailyJournalarticle2The Daily Journal published Wearable Health Tech 12-16-14 Cohen by healthcare & FDA lawyer Michael H. Cohen, as a Part 2 to Future of Medicine is Just a Tap Away.

The article covers legal and regulatory issues involved with fitness tracking devices as they involve into monitoring, storing, and transmitting (to your doctor, hospital, or electronic medical record) more add more health self-data.

Key issues include:

  • Does the capture and transmission of your health information make your smartwatch, app or fitness device tracker an FDA-regulated medical device?
  • Is the information that flows through these devices, subject to HIPAA privacy and security requirements that apply to personal health information (PHI)?
  • Do you need a business associate agreement?
  • Who owns the data generated from wearables?

To address these questions, the article on wearable health technology goes into the various legal and regulatory questions such as:

  • FDA Guidance on Mobile Medical Apps and how this FDA medical device guidance impacts wearable health technology
  • FDA requirement of a cybersecurityplan for medical devices
  • How HIPAA Compliance applies to PHI vs. wearable health tech data
  • The effect of state privacy and security laws, which sometimes contain provisions that mirror HIPAA requirements
  • Business associate agreements and whether they are necessary for app developers and manufacturers and distributors of mobile medical apps
  • Who owns your data

How’s It Going to End?

This was the button on The Truman Show.

We don’t know – but we know how it all begins:

With wearable health technology, we are unsure of the exact divide between wellness and medicine, and wearables blur the distinction. As soon as self-data becomes more widely shared with doctors and part of the patient’s medical record, the paradox of extreme protection and extreme self-sharing will manifest more clearly. As will the paradox between legal protections for personal health information and the notion that your telemedicine provider, mobile medical app developer or wearable manufacturer owns your health data….

As wearable health tech data further enters the medical arena, if only because patients begin sharing the data with their physicians – and data breaches are inevitable – regulatory questions will arise. Companies must know what privacy and security obligations apply, and whether their claim to ownership of patient information goes too far. And policymakers will either conclude that we are under-regulating in an area where companies own all our information — or over-regulating, in an age where nothing is private and everything is shareable.

Truman may have bumped his ship against the edge of the glass, only to find a larger data bubble.

But, the movie ends with Truman’s freedom. Paradoxes abound. Even in an Orwellian world, we may find that there is no one Big Brother, but rather a cascade of Brothers (and Sisters) all of whom are sharing information toward the goal of expanding freedom and health.

Contact our legal team for compliance counsel concerning any healthcare venture, including wearable health tech, mobile medical apps, nanotechnology health products, or other legal and regulatory issues – or call us for a one-hour consult. Join our online community of health and wellness ventures and practitioners, sharing solutions to common legal and regulatory challenges as they pursue their business dream.

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Michael H Cohen Healthcare & FDA Lawyers

Contact our healthcare law and FDA attorneys for legal advice relevant to your healthcare venture.

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