By putting healthcare in the hands of patients, healthcare technology is not only revolutionizing the way we think about medicine, but also the way laws shape personal health.
Digital Health and Patient Engagement
Right now, “patient engagement” is a buzzword. Everyone wants patients to be “engaged” – but whether measuring and recording everything and building a data landfill is beneficial or not, and what the data might yield, nobody knows.
The mantra is: collect, collect, collect, it may be useful later. From fitness tracking to measuring vitals, medical devices are moving out of the doctor’s office and onto our wrists and skins.
Once our smartphones are smarter than us, we will know what everything means. In the meanwhile, innovation is disrupting everything, including the sometimes conflicting and often overlapping sets of laws that govern healthcare services and products.
Digital health personalizes medicine, revolutionizes healthcare, and makes healthcare law anachronistic.
We are seeing Direct Access Testing — patients be able to order their own lab tests (Theranos); direct access to genetic testing (23 and Me); and apps growing more and more sophisticated so as to not only connect patients instantaneously with doctors around the world, but also offer them encyclopedic knowledge for self-diagnosis and self-care.
All of this is closely watched by the FDA, which retains enforcement discretion to intervene if it decides that a particular app veers too much into “diagnosis” or “treatment,” and thus falls within the medical device realm. See our posts:
- FDA Mobile Medical App Guidance Continues to Exert Pressure on Health-Related Apps
- FDA Requires Mobile Apps to Include Disclosures, Adding to FDA Mobile Medical App Regulatory Requirements
- FDA Mobile Medical App Guidance Reads FDA Medical Device Jurisdiction Expansively
- FDA Regulates Mobile Medical Apps, Medical Device Data Systems, and Medical Device Software as “Connected Health”
- FDA Cybersecurity Plan Adds to Mobile App Developer FDA Compliance Burden
- How Telemedicine, Mobile Medical App Laws, Anti-Aging Medicine, and Integrative Medicine are Shaping Our Future
- Does Wearable Tech Give Away Your Quantifiable Self? FDA Medical Device, HIPAA Privacy and Security, and Legal Issues Over Who Owns Your Data
- FDA Eases Regulation of Medical Device Data Systems (MDDS), Medical Image Storage Devices, and Medical Image Communications Devices
- FDA Approves 23and Me’s Personal Genome Test for Boom Syndrome Carrier
- Health Apps as Medical Devices: What It Means for Consumers
FDA knows that the consumer is thinking: Prepare to Wear. And FDA is keeping up with the times by publishing not only the Mobile Medical App Guidance, but also a Guidance document on Low-Risk General Wellness Devices. See our posts:
- FDA is Hands-Off Low-Risk General Wellness Products
- Daily Journal Publishes “FDA’s General Wellness Guidance is Welcome News”
Yet, if the Singularity is near, and exponential technologies (including artificial intelligence) are increasing at hyperspeed, how can a regulatory structure that evolved a century ago, keep pace?
Innovation: Running Circles Around Healthcare Law
The rules are what they are; compliance is a must. And yet, much of healthcare law seems like an anachronism, in light of exponential developments.
Whether we look at:
- HIPAA and cyber-liability
- FTC and state advertising rules
- FDA medical device regulation
- Stark and anti-kickback laws
- Or even, are the state law level, licensing laws, which affect telemedicine
- And prohibitions against corporate practice of medicine
the legal rules are an arcane, byzantine thicket – and penalties for violations, can be draconian.
When interpreting these rules, your legal counsel will tell you that a given interpretation is “arguably defensible.” Arguably means that it is the finest thinking a skilled healthcare or FDA lawyer can muster, yet there are no guarantees. “Enforcement discretion” leaves a lot of room for interpretation.
The irony is that agencies such as FDA and FTC are charged with consumer protection. By bringing the sledgehammer down on offending companies and marketeers, they do protect the public – at the cost of creating enormous legal jeopardy for innovators.
One can come down on one side of the debate or another. As a lawyer representing clients, and counseling them on legal and regulatory boundaries, I appreciate the legal rules, and respect the legal consequences – and advise clients accordingly.
Yet, I’ve always advocated for less paternalism and more emphasis on consumer choices. This is a leitmotif in my books on healthcare law and policy, and speaking on the balance between innovation, passion, and regulation. Paternalistic laws are simply from another age.
Completing the Circle
A client recently recommended The Circle by Dave Eggers. It’s a chilling, dystopian view of the near future in which a corporation so controls people’s data, that it can bend their thoughts and wills to its own agenda – completing eroding democracy in the process.
The circle’s completion is essentially the complete demolishment of personal freedom, the onslaught of unquenchable totalitarianism; and the most insidious aspect is that the whole process, although engineered by a technologically savvy company, is actually welcomed by consumers out of an avalanche of greed for data and convenience.
There are many contenders today for the position occupied by the fictional firm in this book; and the relentless pursuit of technological prowess without the wisdom to contain and meter its power, resonates.
It’s important that companies seek legal counsel so as to dodge compliance bullets; and equally important that regulators understand how some legal rules reflect outdated and overly paternalistic concerns, while marketplace developments pose existential threats to the system as a whole. Lawmakers, companies, and consumers must reckon with far deeper assaults on personal liberty and choice that are, ironically, being created by the very engines of innovation and choice.