Regulating Artificial Intelligence: Transparency, Safety, and Equity

Complications: Health Policy Unraveled

With the recent exponential growth of artificial intelligence technologies, the Biden administration is trying to help guide the nation in the development and deployment of safe, secure, and transparent AI technologies across all sectors, including healthcare.

In episode 19 of Complications: Health Policy Unraveled, host Stephanie Kennan explores the recent regulatory activity related to artificial intelligence. In October 2023, President Biden issued an executive order on the safe, secure, and trustworthy development and use of AI, which would establish a coordinated approach to its implementation in the federal government. Likewise, in December 2023, HHS released its first rule related to AI, called the HTI-1 Final Rule, which will increase transparency, promote coordination among agencies, and promote equity.

Tune in to hear how the Biden administration and HHS plan to regulate AI at the federal level.

Meet Your Host

Name: Stephanie Kennan

Title: Senior Vice President, Federal Public Affairs at McGuireWoods Consulting

Specialty: Stephanie Kennan helps clients navigate the legislative and executive branches of the federal government to solve problems involving a variety of healthcare policy issues. Her work focuses on providers, medical device manufacturers, drug manufacturers and associations concerned about Medicare and Medicaid reimbursement.

Connect: LinkedIn

Episode Highlights

[0:58] President Biden issued an executive order on safe, secure, and trustworthy development and use of AI.

[1:47] Overview of the executive order, which has eight key directives.

[6:00] The executive order would also require HHS to appoint a Chief AI Officer and create an AI task force to oversee the strategic plan for safe use of artificial intelligence in the healthcare sector.

[7:21] Additionally, HHS will need to develop an AI Assurance Policy and AI Safety Program to ensure the safety of AI in the healthcare sector and identify clinical errors as they arise.

[8:16] The executive order also directs HHS to develop a regulatory strategy for the use of AI in drug development.

[9:44] In response to the executive order, HHS released the H2I-1 Final Rule in December 2023 which requires updated standards, specification and certification criteria for electronic health records and health IT modules, including transparency requirements. There are four key provisions to the rule.

[12:42] The Final Rule is particularly significant as it is the first time a final rule has addressed the use of artificial intelligence in healthcare, however, it is expected to cost developers upwards of $914 million.

[13:30] Overall, the Final Rule is meant to promote transparency in attempts to incentivize good AI practices, but allows leeway for clinicians to be trained on the material and to develop trust with the algorithms.

[16:01] Surveys indicate that HHS is one of the top users of AI in the government, ranking fourth among federal agencies.

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