Private equity investors in health care and life sciences must navigate a complex and shifting landscape influenced by regulatory and policy changes and technological advancements. As private equity investments in the health...more
2/13/2025
/ Artificial Intelligence ,
Chevron Deference ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare Reform ,
Hospitals ,
Investment ,
Investors ,
Legislative Agendas ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Machine Learning ,
Medical Devices ,
Medicare Advantage ,
Popular ,
Prescription Drugs ,
Private Equity ,
Regulatory Agenda ,
Regulatory Reform ,
SCOTUS ,
Technology Sector ,
Trump Administration
In the final stretch of the Biden administration, the Food and Drug Administration (FDA) laid the groundwork for continued engagement with the public on two challenging areas of product development, each of which is of high...more
On January 15, 2025, FDA announced an order revoking the listings providing for the use of the color additive FD&C Red No. 3 in both foods (including dietary supplements) and ingested drugs. The order is in response to a 2022...more
On January 7, the FDA made available draft guidance on the development of drugs and biological products for weight reduction within the Center for Drug Evaluation and Research intended for reduction and long-term maintenance...more
1/14/2025
/ Draft Guidance ,
Drug Pricing ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Healthcare ,
Life Sciences ,
New Guidance ,
Pharmaceutical Industry ,
Prescription Drugs ,
Public Health ,
Regulatory Requirements
On January 6 and 7, 2025, the FDA announced, by our count, 31 draft or final guidances, on a wide range of topics. Historically, an incoming administration will impose a temporary freeze on the issuance of guidances and...more
In this edition of Three Questions, health care & life sciences partner Nate Brown spoke with Jeremy Schutz, director of business development, recall & remediation at Sedgwick, to explore key strategies that pharmaceutical...more
With a historic election now behind us, the 118th Congress will return to work for a Lame Duck session to address must-pass items and for Senate Democrats to pass as many final judicial appointments as time and political will...more
On June 28, in Loper Bright Enterprises v. Raimondo, the Supreme Court overturned the longstanding Chevron doctrine, under which courts generally granted deference to a federal agency’s reasonable interpretation of ambiguous...more
7/9/2024
/ Administrative Procedure Act ,
Centers for Medicare & Medicaid Services (CMS) ,
Chevron Deference ,
Chevron v NRDC ,
Corner Post Inc v Board of Governors of the Federal Reserve System ,
Department of Health and Human Services (HHS) ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Healthcare ,
Judicial Authority ,
Life Sciences ,
Loper Bright Enterprises v Raimondo ,
Regulatory Authority ,
SCOTUS ,
Statutory Interpretation
Welcome to the March edition of Akin Intelligence. This month, the EU AI Act was approved by the European Parliament, moving one step closer to becoming the first major AI law. In the U.S., the DOJ brought criminal charges...more
4/10/2024
/ Artificial Intelligence ,
Biden Administration ,
Commercial Litigation ,
Copyright ,
Corporate Governance ,
Cybersecurity ,
Data Privacy ,
Data Security ,
EU ,
Executive Orders ,
Healthcare ,
Innovative Technology ,
Intellectual Property Protection ,
Legislative Agendas ,
Life Sciences ,
Machine Learning ,
National Security ,
Regulatory Agenda ,
Regulatory Reform ,
Regulatory Requirements ,
State and Local Government ,
Technology Sector ,
UK
Last year, both Congress and the Biden-Harris administration noticeably increased their attention on Artificial Intelligence (AI). Key congressional committees explored AI implications for health care & life sciences, and the...more
1/5/2024
/ AHRQ ,
Algorithms ,
Artificial Intelligence ,
Biden Administration ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
Healthcare ,
Life Sciences ,
Machine Learning ,
Transparency
Key Points -
President Biden’s eagerly-awaited executive order (EO) on artificial intelligence (AI) tasks the Department of Health & Human Services (HHS) with promoting responsible AI innovation, development and use,...more
11/13/2023
/ Abbreviated New Drug Application (ANDA) ,
Artificial Intelligence ,
Critical Infrastructure Sectors ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Food and Drug Administration (FDA) ,
FTC Act ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Healthcare ,
HITECH Act ,
Joe Biden ,
Life Sciences ,
Machine Learning ,
ONC ,
Popular
Cloud services have revolutionized the way businesses and governments operate, offering scalability, flexibility, cost-efficiency and security. This is especially the case in the life sciences industry, where the cloud has...more
Multiple policy documents relating to software and digital health have been issued by the U.S. Food and Drug Administration (FDA). The documents offer: a framework for the use of digital health tools in the context of drug...more
In a break with past precedent, last year’s Food and Drug Administration (FDA) user fee reauthorization legislation did not contain significant FDA policy changes. Although the Senate Health, Education, Labor and Pensions...more
FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation -
Key Points -
The Final Guidance does not address the FDA’s risk-based enforcement discretion policy...more
Last month, the Senate Health, Education, Labor and Pensions (HELP) Committee voted 20 to 2 to advance S. 3799, the Prepare for and Respond to Existing Viruses, Emerging New Threats and Pandemics Act (the “PREVENT Pandemics...more
Key Points
- FDA will publish draft guidance on its Predetermined Change Control Plan in 2021 and host a public workshop on transparency requirements around AI/ML-based devices.
- FDA plans to pilot Real-World Performance...more
Medical device and diagnostics companies and laboratories should anticipate significant legal, regulatory and market changes in 2020 that will have a lasting impact on the industry. From revisions to how the government...more
1/8/2020
/ Acquisitions ,
Artificial Intelligence ,
Biotechnology ,
Centers for Medicare & Medicaid Services (CMS) ,
CFIUS ,
Department of Health and Human Services (HHS) ,
Digital Health ,
EU ,
Export Controls ,
Food and Drug Administration (FDA) ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Innovation ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
Mergers ,
Office of Foreign Assets Control (OFAC) ,
Patent-Eligible Subject Matter ,
Pharmaceutical Industry ,
Popular ,
Section 101 ,
USPTO
• In a recent warning letter, the Food and Drug Administration (FDA) advised a laboratory to seek marketing authorization for its genetic tests that qualified as laboratory developed tests (LDTs)—which have largely benefited...more
5/14/2019
/ Clinical Laboratories ,
Enforcement Actions ,
FDA Warning Letters ,
Food and Drug Administration (FDA) ,
Genetic Testing ,
Health Care Providers ,
Labeling ,
Laboratory Developed Tests ,
Life Sciences ,
Marketing ,
Medical Devices
• Life sciences companies are subject to rapidly changing regulatory obligations, government enforcement, and increasing public scrutiny.
• Conducting effective legal and regulatory due diligence can mean uncovering risks...more
5/2/2019
/ Acquisitions ,
Anti-Kickback Statute ,
Due Diligence ,
False Claims Act (FCA) ,
Health Care Providers ,
Investors ,
Life Sciences ,
Medicaid ,
Mergers ,
OIG ,
Patient Referrals ,
Private Equity ,
Provider Payments ,
Safe Harbors ,
Sunshine Act ,
TRICARE ,
Venture Capital