FDA Sets It’s Sights on Silicon Valley’s Digital Health Boom

As the digital health market continues to grow rapidly, it is expected that regulatory scrutiny from the Food and Drug Association (FDA) and the US Federal Trade Commission (FTC) would continue to increase in innovation centers across the US, specifically Silicon Valley.

“When the process is managed right, we know that the government can be a powerful ally rather than an impediment to innovation,” said Morgan Lewis partner Michele Buenafe, who advises clients on emerging legal issues relating to digital health platforms such as mobile medical apps, clinical decision support software, telemedicine systems, wearable devices, genomic test systems, and other health information technology. “Earning the FDA’s clearance or approval can help distinguish a product from the rest of the pack and provide legitimacy in a market that’s becoming more skeptical of unsupported or idealistic health claims.”

The Morgan Lewis team is comprised of FDA and Intellectual Property (IP) lawyers who work closely with companies specializing in life sciences and medical devices. Their team works with these companies to smooth the journey from laboratory to the marketplace; navigating through all aspects of the legal and regulatory process they may encounter in the digital health technology space.

These technology innovations have the potential to shape the future of health care. The intellectual property associated with these technologies also needs to be properly protected, meaning a growing area for concern for lawyers and companies.

“Investment in digital health companies has increased rapidly over the past five years,” said Morgan Lewis partner Brett Lovejoy, who helps businesses create patent portfolios and provides strategic intellectual property counseling. “Digital health organizations are pursuing a number of legal strategies to protect their digital health IP in the context of today’s challenging legal climate, which is marked by recent court decisions that make it more difficult for companies to acquire intellectual property.”

Partners at Morgan Lewis law firm recently answered a few questions specific to how companies in the health care technology field could better protect their business. Below is a brief summary:

How often do you see regulators contacting clients now compared to five years ago?

The FDA has really made an effort to understand which technologies are more low risk and may be appropriate for enforcement discretion (i.e., exempt from FDA regulation). Because the FDA and FTC are still working to develop comprehensive digital health policies, there are significant opportunities for industry to engage with these regulators to help shape where they are going.

Today, high profile regulatory actions and consumer litigation against health tech companies have reminded the market that these technologies come with risks from both a regulatory and safety standpoint. It remains to be seen, however, how this may impact the FDA’s and FTC’s policy development going forward.

What should digital health company leaders be thinking ahead about when it comes to protecting their new technologies?
Although leading cases, such as Mayo v. Prometheus Labs, Inc., Ariosa Diagnostics Inc. v. Sequenom and Alice v. CLS Bank have created a challenging environment for digital health patent protection in the United States, patent protection remains an important tool for protecting innovation in this space. A number of more recent cases, such as Exergen Corporation v. Kas USA and Enfish LLC v. Microsoft Corp., as well as subject matter eligibility examples disseminated by the United States Patent and Trademark Office have provided new pathways to seeking patent protecting in the United States. Patent protection for digital health innovation in Europe is guided by the analysis provided in the European Patent Office (EPO) board decisions T0784/06 (technical effect not found) and T2050/07 (technical effect found).

When does the FDA or other regulator take notice to raise questions about products?

Federal regulators are always on the lookout for unapproved products that pop up as a result of a public health issue or health trend. For example, the FTC has taken enforcement actions against marketers of mobile apps intended to diagnose melanoma and the FDA has issued a number of enforcement letters in recent months against companies marketing unapproved direct-to-consumer pharmacogenomic tests involving software-based analysis. The FDA and FTC also may act as the result of trade complaints filed by competitors or safety complaints received from patients or healthcare providers.

As the digital health market continues to grow, what’s next?

On the regulatory front, we’re waiting for the final FDA guidance documents for general wellness devices and device accessories, and the new draft guidance on clinical decision support and machine learning technologies. Looking further down the line, companies should understand that the FDA’s and FTC’s policy development for digital health is never really over. Innovation will continue to march on, and federal regulators will have to try to keep up as new and disruptive technologies continue to emerge.

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