Key Takeaways from Digital Health Counsel 2024 AI Summit

Walking away from Digital Health Counsel 2024 AI Summit, the stunning impact that AI and data-powered innovation are making on healthcare is undeniable. Organized by Ogden Murphy Wallace and sponsored by Fenwick, the summit was a fantastic opportunity to connect and exchange ideas with fellow lawyers, in-house professionals, and industry leaders leading the way in this exciting space.

Here are a few takeaways from the panels we spoke on and the week in general:

AI governance is taking center stage. AI governance is becoming an increasingly critical issue across industries—particularly in healthcare—as new legislation, rulemaking, conventions, case law, etc. continue to flesh out this fast-developing space. The EU’s AI Act has entered into force and is gradually entering effect alongside a host of state-specific legislation in the United States, including 17 AI bills recently signed by California Gov. Gavin Newsom covering a gamut of issues, including disclosure, transparency, and digital likenesses. But beyond these new laws, it’s important to keep track of various emerging AI governance frameworks, such as the National Institute of Standards and Technology’s AI Risk Management Framework, which is increasingly being featured in AI-specific legislation.

Don’t fear the regulator. While the FDA has not yet authorized any generative AI-based medical devices—or issued formal rules specifically about generative AI—the agency is actively assessing the technology and various regulatory strategies. But digital health startups should not be intimidated—instead, employ best practices for engaging with the FDA and maintain open lines of communication to help minimize your risk. Given the unique aspects of generative AI, post-market performance monitoring will likely be an important regulatory tool.

Women’s health is hitting an inflection point. Did you know women were excluded from clinical trials until 1993? Gaps like this nonetheless persist in our healthcare system, but these very gaps create opportunities for innovators to find new solutions to bridge them. Investments addressing the women’s health gap could potentially reduce the time women spend in poor health by almost two-thirds while boosting the global economy by $1 trillion annually by 2040, according to a recent McKinsey Health Institute report. And it’s not only private collaborations that can fuel this boom. A growing number of government opportunities —like $100 million for women’s health initiatives the White House announced earlier this year—present exciting new funding alternatives.

Prioritize empathetic and ethical AI. Accuracy is not enough. AI—particularly in the healthcare context—must operate ethically and from a place of empathy. And this starts with mitigating bias from the underlying data used to train the AI or machine-learning algorithm. Not only does that encourage more equitable and empathetic service for end users; it can also reduce the risk of hallucinations that pose broader technical problems.

Interested in learning more? Explore Fenwick’s healthtech capabilities and insights.