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Telehealth Transformation: Innovating Mental Health Care Life Sciences Snapshot – Q1 2025

Q4 2024 marked the conclusion of a turnaround year for life sciences venture investment. After two consecutive years of declining activity and macroeconomic uncertainty, the dust has settled, and investment is back on the...more

The Download: A Private Sector Model for Responsible AI in Healthcare & Why Value-Based Care Is Good Business

WHAT WE'RE SEEING - In this Life Sciences & Healthtech edition of The Download, we take on key trends at the intersection of tech and healthcare, continuing the energizing conversation from JPM Healthcare last week. 01 A...more

FDA Proposes Draft Guidance on Assessing the Credibility of AI Models Used in Drug and Biological Product Submissions

The FDA has shared its first draft guidance on how sponsors should assess the credibility of artificial intelligence (AI) models to support FDA decisions regarding drug safety, effectiveness or quality. The agency noted an...more

FDA Issues Draft Guidance on AI-Enabled Medical Devices

The FDA has shared draft guidance on the design and development of AI-enabled medical devices and marketing submissions for those devices. The Importance of Engaging Early Sponsors of AI-enabled devices should engage with the...more

DEA Issues Third Extension of Telemedicine Prescribing Flexibilities

The Drug Enforcement Administration (DEA) has issued the “Third Temporary Extension of COVID-19 Telemedicine Flexibilities for Prescription of Controlled Medications” (Third Extension), which extends the flexibilities...more

Life Sciences Snapshot – Q4 2024 – A Quarterly Report on Financing Trends

Since the previous quarter’s Life Sciences Snapshot, robust dealmaking activity in Q3 has launched YTD life sciences VC deal activity to near parity with 2023 figures, firmly positioning 2024 as the year to break the two-year...more

U.S. States Begin Regulating Generative Artificial Intelligence in Health Care

The health care industry has utilized artificial intelligence for decades, but the recent expansion of AI’s capabilities into generative AI models is raising questions about how and to what extent to regulate the technology....more

Texas Attorney General Reaches Novel Generative AI Settlement: What Health Tech Companies Need to Know

The Texas Attorney General is once again signaling the office’s intent to enforce the state’s privacy and consumer protection laws. According to a June 2024 press release, Texas Attorney General Ken Paxton “launched a major...more

Increased Scrutiny of Private Investment in Health Care: Key Insights for Health Care Innovators and Investors

Federal agencies and lawmakers in several states are attempting to rewrite the rulebook for private investment in health care in the U.S. California and other states are considering new regulations reinforcing state...more

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