How to resolve wearable tech legal and regulatory issues without wearing out your legal budget

Wearable technology legal and regulatory issues can sidetrack your wearable tech venture, unless you’re savvy about navigating the legal landscape. Wear your wearable tech on your sleeve – not your legal issues.

Here’s what you need to know.

The legal and regulatory for wearable technology is emerging, but that doesn’t mean there is no map.

Healthcare technology, wearable or otherwise, is subject to a variety of laws and regulations. Most prominent among these are:

  • FDA regulation of mobile medical apps
  • FDA laws governing medical devices
  • FTC regulation of online and mobile advertising
  • laws and regulations governing healthcare data privacy and security
    (HIPAA as well as analogous state laws governing the privacy and security of healthcare data)
  • intellectual property issues governing ownership of data

The future of medicine keeps morphing: first it’s telemedicine, then it’s m-health, and now wearable devices. See:

“From Physical to Mobile to Wearable Healthcare: How Government Regulation of User-Generated Health Data Affects Ventures and Consumers”

The Silicon Valley Business Journal writes in Wearable tech may promise better health care:

The future of medicine may rely on a new wave of wearable devices designed to gather your biometric information and make your medical records more accessible to third parties — including technology companies and non-primary physicians….

A panel of physicians and executives shed some light Wednesday on the latest push by tech firms and health care providers to use wearables to facilitate remote diagnoses and treatments of patients. In sum, they’re poised to make consumer electronics vital components of the clinical marketplace.

The advancements in telemedicine also kindle fresh concerns over personal privacy and data security, heightening risks of exposing intimate information…

The article goes on to cite HIPAA concerns over unencrypted data as “just one hurdle.”

HIPAA, as we know, requires that protected health information (PHI) be kept private and secure–and HIPAA imposes a host of obligations on “business associates” who create, receive, maintain, or transmit PHI, as well on covered entities.

Of course, there’s a threshold question as to whether HIPAA even applies, if there is no claim for healthcare reimbursement. And state laws that mirror HIPAA, in terms of attempting to protect the privacy and security of medical data, often contain far more ambiguity than the detail-rich mandates of HIPAA.

In the article, Daniel Kraft of Singularity University goes on to predict that doctors may be “prescribing wearable devices and health sensors as part of their whole health care element.”

This seems like a reasonable prediction.

When it comes to wearable health technology, physicians will have to deal with HIPAA issues, informed consent, medical malpractice / standard of care, and other issues that also arise in the telemedicine or telehealth context. And, these legal issues arise not only in regular medical practice, but also in concierge medicine (or direct primary care), since this involves availability on a more extended basis than in regular practice.

Ventures will need to think through FDA medical device issues. Apps that do more than track fitness, can slide into the regulatory definition of a medical device – triggering a host of regulatory requirements.

The federal Food, Drug, & Cosmetic Act (“FDCA”) defines a medical device as:

an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is—

(1) recognized in the official National Formulary, or the United States Pharmacopeia, or any supplement to them,

(2) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or

(3) intended to affect the structure or any function of the body of man or other animals, and

which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

A mobile medical app is used as an accessory to a regulated medical device; or transforms a mobile platform into a regulated medical device.”

Class 1 medical devices are subject to FDA’s general controls including:

  • establishment registration and medical device listing
  • quality system regulation
  • labeling requirements
  • medical device reporting
  • premarket notification
  • reporting corrections and removals
  • investigational device exemption (IDE) if appropriate

Class 1 medical devices have the lowest risk to the patient; Class 2 medical devices are riskier; and Class 3 medical devices have the highest level of FDA regulation.

Our law firm has expertise in the many areas of law that come together to inform wearable technology ventures.

Book your Legal Strategy Session now
Michael H Cohen Healthcare & FDA Lawyers

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

Start typing and press Enter to search