LSHC Horizons Brochure 2024 - Flipbook - Page 17
Hogan Lovells | 2024 Life Sciences and Health Care Horizons | Digital Health and AI
17
Looking ahead to the U.S. regulation of Health AI
In the U.S., federal and state regulators are
poised to expand the regulation of artificial
intelligence for health-related purposes (Health
AI). To date, many regulatory and legislative
efforts targeting Health AI have taken the
form of high-level guidelines, non-binding
recommendations, voluntary commitments, and
agency guidance, such as Executive Order 14110,
the Health Sector AI Commitments, and Centers
for Medicare & Medicaid Services’ (CMS) AI
Playbook. Binding legal and regulatory efforts
are, however gaining momentum.
The lead agency on health care in the U.S., the
Department of Health and Human Services
(HHS), has taken a number of concrete steps
toward the support and regulation of Health AI
with a focus on research and discovery, drug
and device safety, health care delivery, and
public health. In just the past year:
• The Office of the National Coordinator
for Health information Technology
(ONC) finalized a rule requiring increased
transparency in the use of AI in certified
health IT.
• FDA published a draft guidance document
outlining a framework for regulating AI and
machine learning (AI/ML) enabled device
modifications as well as guiding principles.
Federal and state legislators are moving at a
relatively fast pace in this area. Congress held
multiple hearings on AI, including a health
subcommittee hearing on Understanding
How AI is Changing Health Care. States
are introducing laws that protect privacy
and prohibit discrimination that may result
from implementing AI in the health sector
focused largely in three areas: (1) preventing
discrimination when health care providers
use AI-powered automated decision systems;
(2) increasing transparency by giving patients
the right to know when an algorithm is used
as part of their care; and (3) requiring consent
and use of only pre-approved technologies
that are monitored and shown to achieve
accurate results.
In anticipation of new requirements,
businesses can:
• evaluate their Health AI use cases with a
focus on ensuring fair, appropriate, and
safe use;
• document measures taken to support
transparent and responsible development
and use of Health AI; and
• implement safeguards to protect individuals’
rights and minimize bias, discrimination,
and other AI-specific risks.
• The National Institute of Health (NIH)
announced new initiatives to fund
development of AI/ML tools and improve the
usability of NIH-supported data for AI/ML
analytics and started a program to support
underrepresented communities in the
development of AI/ML models.
Marcy Wilder
Partner
Washington, D.C.
Alyssa Golay
Senior Associate,
Washington, D.C.
Jessica Hanna
Counsel
Washington, D.C.
