February 5, 2023

Volume XIII, Number 36

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February 03, 2023

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FDA Joins Other Regulators in Focus on AI and Machine Learning

The Food and Drug Administration recently sought comments on the role of transparency for artificial intelligence and machine learning-enabled medical devices. The FDA invited comments in follow up to a recent workshop on the topic.

The workshop was part of a series of efforts the FDA has had in this space. These include its Digital Health Center of Excellence and a five-part Action Plan for AI and machine-learning enabled medical devices. As part of the action plan, the FDA indicated it wants to issue guidance on software learning over time and help the industry be “patient-centered.” In other words, that companies be transparent when using AI and machine learning-enabled software with patients. These initiatives are especially important given the increase in AI/ML in healthcare.

Workshop participants explored how to provide transparency.  One idea proposed was using a “nutrition fact label” approach to give individuals enough information to make informed decisions. The graphic would be similar to a food label, disclosing quickly and visually the key things patients might want to know. (This is similar to an approach launched by Apple late last year, which we discussed here.) Other agencies have looked at machine learning and AI with similar transparency recommendations. We have written about those in the past, including for the financial services industry. Advice about use of these tools has also been issued by the FTC and the EU.

Putting it Into Practice: While the FDA continues to explore this area, companies are reminded that the FDA (like other regulators) expects transparency with consumers. From a privacy perspective, the workshop reminds digital health companies this includes telling users when AI or ML-enabled software is being used.

Copyright © 2023, Sheppard Mullin Richter & Hampton LLP.National Law Review, Volume XI, Number 326

About this Author

Liisa Thomas, Sheppard Mullin Law Firm, Chicago, Cybersecurity Law Attorney

Liisa Thomas, a partner based in the firm’s Chicago and London offices, is Co-Chair of the Privacy and Cybersecurity Practice. Her clients rely on her ability to create clarity in a sea of confusing legal requirements and describe her as “extremely responsive, while providing thoughtful legal analysis combined with real world practical advice.” Liisa is the author of the definitive treatise on data breach, Thomas on Data Breach: A Practical Guide to Handling Worldwide Data Breach Notification, which has been described as “a no-nonsense roadmap for in-house and...

Allison Fulton DC SheppardMullin Shareholder Life Sciences FDA

Allison Fulton is a partner in the Life Sciences and FDA team and is based in the firm's Washington, D.C. office. Allison advises life sciences companies, including pharmaceutical, medical device, dietary supplement, food and cosmetic companies, in matters relating to the development, manufacture, and marketing of products regulated by the U.S. FDA.

Areas of Practice

Allison’s areas of focus include assisting U.S. and international companies comply with current Good Manufacturing Practice (GMP) and the Quality System Regulation (QSR). She regularly advises...

Sara Helene Shanti Corporate Lawyer Sheppard Mullin Law Firm

Sara Helene Shanti is a partner in the Corporate Practice Group in the firm's Chicago office.

Areas of Practice

Shanti represents healthcare providers and technology companies in matters related to data privacy, healthcare regulatory compliance and mergers and acquisitions. She counsels clients on various data privacy and healthcare technology matters, including artificial intelligence, data security incidents, mobile applications, and telemedicine. Shanti’s experience includes advising clients on transferring data across multinational borders, implementing...

Anahita Anvari Corporate Attorney Sheppard Mullin Law Firm

Anahita (Ana) Anvari is an associate in the Corporate Practice Group in the firm's Century City office and is a member of the firm’s healthcare practice team.

Areas of Practice

Ana represents clients in the health care industry through business and transactional matters, including mergers & acquisitions and corporate governance. She advises clients on regulatory compliance under federal and state law, including licensure and fraud and abuse compliance. She also guides clients through health privacy issues, including HIPAA.