Digesting recent government updates
It’s not all turkey pardons—the past several weeks have seen a flurry of government activity impacting the digital health sector. President Biden ordered HHS to align on regulatory approaches to ensure safety, security, and equity across AI healthcare applications. Meanwhile, the FDA updated its list of AI/ML-enabled devices legally marketed in the U.S. and spotlighted trends across 500+ included algorithms. On Capitol Hill, the Senate Finance Committee advanced the Better Mental Health Care, Lower-Cost Drugs, and Extenders Act, which would require pharmacies to report costs for medication data, and pushes for increased access to mental health care for children on Medicaid as well as Medicare patients in rural and underserved areas. To round things out, the White House launched an initiative on Women’s Health Research, which will deliver recommendations for action within 45 days.
Policy is a powerful lever to drive private market innovation. The 21st Century Cures Act has created opportunities for interoperability innovation, while price and coverage transparency rulings have catalyzed new data-sharing tools and partnerships. Similarly, we expect that recent regulations will spur new startups, partnerships, and product launches that target earmarked funding or compliance requirements.
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