Rachel Snyder Good, Strategic Counsel in the Health Care & Life Sciences practice, in the firm’s Baltimore and Washington, DC, offices, was quoted in Law360, in “'Devil's in the Details' of Biden's AI Health Plans, Experts Say,” by Gianna Ferrarin. (Read the full version – subscription required.)

Following is an excerpt:

BigLaw experts have praised President Joe Biden's sweeping plan to harness the powers of artificial intelligence to develop potent cancer treatments, improve equity in the medical field and otherwise serve patients and heal the ills of the U.S. health care industry.

But many are also keen to see how the administration's ambitious plans will be implemented across all levels of government, and better understand the potential application of AI guardrails in areas such as patient privacy and algorithmic bias.

"Health care is so regulated, with Medicare, Medicaid, the FDA processes — there are processes that are already in place," said Rachel Snyder Good, a health care strategic counsel at Epstein Becker Green. "And so we need to make sure that we're being clear on where there is regulation needed and where there is legislation needed." …

HHS must also craft guidance on building privacy standards into the software development cycle, safety and performance monitoring of AI technologies, and the uses of AI to reduce administrative burdens in the health sector.

"I think having this oversight and making sure that these safeguards are in place without crushing innovation is just the key to making AI work, elsewhere but particularly in health care," said Good. …

According to the order, HHS also has 365 days to develop a strategy for regulating the use of AI in the drug development process, including defining objectives for the regulation of different phases of drug development and identifying where additional statutory authority may be needed to regulate this process.

"These tight turnaround times — I was glad to see that it was 180 days for this or 365 days for that — means that the government will have compiled all of this great information before the election," said Good. "And no matter who is the next administration, whether it's a continuation of this one or a new administration — this is a bipartisan issue. This is something everybody agrees needs to happen." …

Good, who previously served as a policy adviser in the House of Representatives for several years, emphasized the need for industry groups to weigh in as government agencies and Congress develop regulations and legislation in response to the order.

"This is a really big step forward," Good said. "But that's all it is — it's the beginning of a process. And I know that people are anxious to know where it's going to go. But I'm glad to see the process starting."

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