Mobile phone applications are already tracking intimate health data, including our sleep habits, steps walked, body measurements, nutrition, and more. Apps draw this information from the devices many of us now religiously maintain along with our daily wardrobe. In this data-hungry age, doctors and health care providers can apply artificial intelligence (“AI”) to the data to help them provide patients personalized and immediate help. The mobile applications, wearable devices, and artificial intelligence use are here to stay. But how will the federal government push its regulatory frontiers to permit the use of such technologies?
To highlight the new federal efforts to accommodate these technologies, Hogan Lovells US LLP partners, Yarmela Pavlovic and Trey Hanbury, hosted a Health Care and the Internet of Things: New Regulatory Developments webinar on July 25, 2019.
Federal Drug Administration (FDA) regulatory update
Ms. Pavlovic explored how the FDA is approaching regulating new medical tools, solutions, and products. Here are the general steps the FDA follows when assessing whether or not to regulate a product.
- Is the tool/solution/product regulated?
- The Federal Food, Drug and Cosmetic Act and 21st Century Cures Act provide (and expand upon) the definition of a medical device.
- Does the tool/solution/product fall into any special policy categories?
- FDA can employ enforcement discretion and not regulate low-risk products, such as guidance documents on mobile medical applications or draft guidance on general wellness products.
- Enforcement discretion could be with respect to all FDA requirements or only certain requirements (eg., premarket clearance/approval).
- What is the regulatory pathway?
Mr. Hanbury explained what AI is, including present-day AI applications as well as federal government efforts to develop technical standards and related tools for AI. He analyzed efforts by the National Institute of Standards and Technology (“NIST”) to promote innovation and investment in AI. Mr. Hanbury focused on NIST’s May 2019 AI Request for Information (“RFI”). In the RFI, NIST requested information on priority areas for federal involvement in AI standards-related activities, including information on the current state and availability of AI technical standards.
Ninety-nine leading companies, prominent associations, forward-looking academics, and ordinary consumers responded to the RFI with comments. Interested parties included edge providers, such as Google, Amazon, and Microsoft; members of the healthcare sector, such as Anthem and Kaiser Permanente; various trade and professional associations, such as BSA | The Software Alliance, ACT | The App Association, and the Consumer Technology Association; and many other parties.
From the submissions, Mr. Hanbury saw three areas of broad consensus.
- NIST should engage with international standards-setting organizations and represent U.S. interests in harmonizing global AI standards.
- NIST should rely on voluntary, consensus-based standards to promote innovation and maintain U.S. global competitiveness.
- NIST should promote public-private partnerships between industry and the government, though federal funding for research and by making federal data sets and use cases more publicly accessible.
FDA Regulation of AI/Machine Learning (“ML”)
Ms. Pavlovic discussed the FDA’s policies for AI/ML products. It has released discussion papers, provided draft guidance on clinical and patient decision support tools, contemplated various carve-outs, and created a “pre-cert” program, which the FDA unveiled July 27, 2017 as part of its Digital Health Innovation Action Plan. Nine companies have entered the pilot program, where the FDA has shifted its focus to certifying software-as-a-medical-device developers instead of its traditional focus on product clearance or approval.
The federal government has taken notice of the technological potential of AI and Internet of Things (“IoT”) and is moving rapidly to understand whether and how to accommodate AI-powered devices, products, and solutions into its existing regulatory structures. AI and IoT promise to affect hundreds of millions of businesses and consumers across a broad range of disciplines. To hear more of Ms. Pavolvic’s and Mr. Hanbury’s thoughts on the complex competitive, legal, and ethical issues these advances pose for the medical sector, we invite you to watch the full webinar.