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Software Update: The Latest on FDA’s Pre-Cert Pilot

July 22, 2019 | Blog | By Aaron Josephson

Regular readers of this blog know that we’re closely following the FDA’s proposed regulatory framework for software as a medical device (SaMD), known as precertification—Pre-Cert for short. Generally, Pre-Cert involves a premarket evaluation of a software developer’s culture of quality and organizational excellence and continual, real-time postmarket analyses to assure software meets the statutory standard of reasonable assurance of safety and effectiveness.
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Strategies to Unlock AI’s Potential in Healthcare Part 6: Commercialization of AI Tools in Healthcare – the Challenge of Securing Adequate Data Rights

November 26, 2018 | Blog | By Julie Korostoff

In this sixth post in our series on artificial intelligence in health care, Julie Korostoff highlights the importance of securing adequate data rights to commercialize an AI technology. The post addresses the contractual commitments that a developer of a healthcare AI tool should secure in order to have the data rights necessary for development and commercialization.
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Strategies to Unlock AI’s Potential in Health Care, Part 5: Product Liability Prevention for AI Product Designers—and Their Lawyers

November 13, 2018 | Blog | By Yalonda Howze

As our use of AI technology becomes more frequent, interconnected, and integral to daily life, the liability exposure to AI product designers and manufacturers continues to escalate. There are more potential liability risks, including product liability risks, in our current environment than ever. With AI technology embedded in interconnected software and hardware products, gone are the days where we can neatly separate data security and privacy from product liability exposure.
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Strategies to Unlock AI's Potential in Health Care, Part 4: How and When Will Congress Act?

November 2, 2018 | Blog

The rise of artificial intelligence (AI) developments over the last decade has had profound implications for the health care industry. From IBM’s Watson to lesser known innovations that have flown under the radar, such as clinical decision software and predictive analytics, these changes have infiltrated the field’s daily functions. Congress generally views AI with trepidation and fascination. We expect Congress to keep the subject at arm’s length until provoked to action.
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Strategies to Unlock AI's Potential in Health Care, Part 3: HIPAA and Other Privacy Considerations

October 25, 2018 | Blog | By Dianne Bourque

Software developers are racing to develop health care products that leverage artificial intelligence (AI), including machine learning and deep learning. Examples include software that analyzes radiology images and pathology slides to help physicians diagnose disease, electronic health records software that automates routine tasks, and software that analyzes genetic information to support targeted treatment. The one thing that all of these products have in common is a need to interact, in some way, with real world medical data. However, this real world data can be protected by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) as well as a patchwork of federal and state laws and regulations. Below we discuss the contexts in which developers may encounter these laws, as well as strategies to navigate related legal issues.
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Strategies to Unlock AI's Potential in Health Care, Part 2: FDA’s Approach to Protecting Patients & Promoting Innovation

October 18, 2018 | Blog | By Aaron Josephson

Artificial intelligence—AI—is the future of everything. But when patient health is on the line, can we trust algorithms to make decisions instead of patients or their health care providers? This post, the second in our blog series about AI in health care, explores FDA’s proposed regulatory model that is supposed to be better suited for AI (and similar technologies) while still protecting patients.
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Strategies to Unlock AI’s Potential in Health Care, Part 1: Common Pitfalls to Avoid When Getting a Patent

October 12, 2018 | Blog | By Christina Sperry

As in any technology area, it is important to consider patent protection early in the development of an AI-related invention. However, AI inventions raise a number of particular issues that, if not addressed fully or at the right time, could be fatal to securing U.S. patent protection that would otherwise be available to prevent others from making, using, selling, or importing the invention. This article identifies common pitfalls in getting a patent for AI inventions and provides insights on how to avoid them. These principles apply not only to AI-related inventions, but also to digital health inventions more broadly.
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Strategies to Unlock AI’s Potential in Health Care, a Mintz Series

October 12, 2018 | Blog | By Ellen Janos

The Journal of the American Medical Association in its September 18, 2018, issue included four articles on deep learning and Artificial Intelligence (AI). In one of several viewpoint pieces, On the Prospects for a (Deep) Learning Health Care System, the author’s conclusions aptly describes why health care providers, entrepreneurs, investors and even regulators are so enthusiastic about the use of AI in health care.
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