As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving...more
4/1/2025
/ Department of Health and Human Services (HHS) ,
Diagnostic Tests ,
Electronic Protected Health Information (ePHI) ,
Food and Drug Administration (FDA) ,
Government Shutdown ,
Life Sciences ,
Medical Devices ,
New Regulations ,
Pharmaceutical Industry ,
Proposed Rules ,
Regulatory Requirements ,
Tariffs ,
Trump Administration ,
US Trade Policies
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape....more
10/1/2024
/ Biden Administration ,
Biologics ,
Clinical Trials ,
Department of Health and Human Services (HHS) ,
Diversity ,
Draft Guidance ,
EU ,
European Medicines Agency (EMA) ,
Executive Orders ,
Final Rules ,
Food and Drug Administration (FDA) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Information Reports ,
Laboratory Developed Tests ,
Life Sciences ,
Med Tech ,
Medical Research ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
New Guidance ,
OCR ,
Pediatrics ,
Pending Legislation ,
Personal Data ,
Pharmaceutical Industry ,
Scientific Research ,
UK
On October 30, 2023, President Biden issued an Executive Order (EO) on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence. The EO establishes sweeping directives and priorities for federal...more
11/1/2023
/ Artificial Intelligence ,
Biden Administration ,
Civil Rights Act ,
Cybersecurity ,
Department of Health and Human Services (HHS) ,
Executive Orders ,
Federal Procurement Systems ,
Intellectual Property Protection ,
Legislative Agendas ,
National Security ,
NIST ,
Popular ,
Proposed Legislation ,
Public Agencies ,
Regulatory Agenda ,
Semiconductors ,
Technology Sector
Throughout August 2023, the Office of Information and Regulatory Affairs, Office of Management and Budget, Executive Office of the President (“OIRA”) has held stakeholder meetings regarding a proposed rule which, if enacted,...more
Medtech companies are evolving rapidly as more and more of them develop products that collect and leverage substantial patient and provider data.
Companies that once only developed hardware-based solutions for...more
5/26/2023
/ Anti-Kickback Statute ,
Artificial Intelligence ,
Compliance ,
Cybersecurity ,
Data Collection ,
Data Privacy ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Food and Drug Administration (FDA) ,
Information Blocking Rules ,
Intellectual Property Protection ,
Med Tech ,
Medical Devices ,
Patent-Eligible Subject Matter ,
Popular ,
Safe Harbors ,
Software
In early 2023, the Biden administration announced and set into motion its plans to wind down a number of pandemic-related programs and allow the COVID-19 public health emergency (PHE) declaration, which has been in effect...more
On November 15, 2021, the U.S. Food and Drug Administration (“FDA” or the “Agency”) issued the fifth edition of the Agency’s guidance entitled “Policy for Coronavirus Disease-2019 Tests During the Public Health Emergency.”...more