Election 2024: Healthcare Innovation in the US - McDermott Will & Emery

Election 2024: Healthcare Innovation in the US

|

Overview


Jennifer Geetter’s practice focuses on privacy, data governance, AI, genetics, consumer health apps, and other issues at the intersection of healthcare and innovation. See her thoughts below on how the outcome of the 2024 US election could affect the healthcare space.

In Depth


How would a Harris-Walz administration affect clients in your practice?

Bottom line: It would likely put to rest or delay debates about the Affordable Care Act (ACA), allowing health policy and legislation to focus on other considerations. It would also likely bring greater clarity and calm to digital health-related considerations around reproductive health, including privacy and consumer health information.

Added context: Many of the healthcare innovation legal topics that my clients are contending with are highly technical areas and appear not to be significant partisan focuses. (For example, emerging standards for healthcare information exchange, generative AI in healthcare, state and federal data privacy considerations, a raft of ransomware and critical infrastructure threats, the growing industry of consumer health data, and the expanding role of genetics in healthcare.)

A key driver on whether either election result impacts these areas will be the degree of deference and encouragement the new administration gives to federal agencies to address these issues, and whether Congress has the discipline and focus to enact legislation.

How would a Trump-Vance administration affect clients in your practice?

Bottom line: Much of the oxygen in healthcare policy debates would likely be exhausted by legislative efforts to 1) curtail or repeal the ACA and 2) further restrict access to abortion and abortifacients at the state level.

Added context: This will preoccupy both Democrats and Republicans and make it more difficult to attract sustained attention on other pressing issues.

With either administration, what should clients be most focused on from a regulatory and enforcement perspective?

Bottom line: It remains to be seen how the federal government will participate in AI regulation. There are nascent efforts within certain agencies, but there is no national response yet.

Added context: The Change Healthcare ransomware highlighted that cyber-attacks are not “only” privacy events – they can disrupt critical services such as, in this case, basic pharmacy functioning.

How the federal government responds to this reckoning is a key question. In the realm of AI, it is increasingly necessary to distinguish between the risks that can be identified and managed through strong AI development and governance programs and the risks that cannot. There are risks inherent in generative AI that require a sober, highly technical, national security-focused, multinational threat analysis response to address existential-level risks such that the hard work to implement compliance programs and safeguards is truly productive, not just performative.

I will also be watching the role of the Federal Trade Commission (FTC) vis-à-vis consumer protection carefully. The current FTC has been very active on AI, privacy, and other consumer health-related topics.