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
On December 27, 2024, the US Department of Justice (DOJ) issued a final rule establishing a new national security program to prevent access to Americans’ bulk sensitive personal data and government-related data by China...more
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Draft Guidance ,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
As the life sciences, medtech, and diagnostic industries continue to expand and grow increasingly complex, so does the legal, regulatory, and compliance landscape. ...more
7/2/2024
/ Biologics ,
Clinical Trials ,
Congressional Committees ,
Diversity ,
Draft Guidance ,
EU ,
European Commission ,
Final Rules ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Medical Devices ,
Medicines and Healthcare Products Regulatory Agency (MHRA) ,
Patient Privacy Rights ,
Pediatrics ,
Pharmaceutical Industry ,
PHI ,
Prescription Drugs ,
Proposed Legislation
Since the passing of the California Consumer Privacy Act (CCPA) in 2018, California has led the nation in privacy regulation and enforcement. But, beginning July 1, 2024, Texas will be the new sheriff in town....more
On March 31, 2024, the Washington My Health My Data Act (MHMDA), a comprehensive consumer health privacy law, will come into force. Small businesses – defined as those processing consumer health data of fewer than 100,000...more
3/29/2024
/ Advertising ,
Consent ,
Consumer Privacy Rights ,
Data Privacy ,
Exemptions ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Notice Requirements ,
Patient Privacy Rights ,
Personal Data ,
PHI ,
Popular ,
Small Business ,
State Privacy Laws ,
Wellness Programs
On October 7, 2022, President Biden signed an Executive Order on “Enhancing Safeguards for United States Signals Intelligence Activities,” establishing new privacy safeguards and oversight mechanisms for foreign intelligence...more
10/10/2022
/ Administrative Review Board ,
Biden Administration ,
Civil Liberties ,
Court of Justice of the European Union (CJEU) ,
Data Privacy ,
EU ,
EU-US Privacy Shield ,
Executive Orders ,
Foreign Intellgence ,
International Data Transfers ,
National Intelligence Agencies ,
Personal Data ,
Schrems I & Schrems II ,
Standard Contractual Clauses ,
Surveillance
On 25 March 2022, President Biden and the President of the European Commission (“EC”) von der Leyen announced that the U.S. and EU reached an agreement in principle on a new Trans-Atlantic Data Privacy framework for...more
3/30/2022
/ Court of Justice of the European Union (CJEU) ,
Data Protection ,
EU ,
EU-US Privacy Shield ,
European Commission ,
European Court of Justice (ECJ) ,
European Data Protection Board (EDPB) ,
International Data Transfers ,
Personal Data ,
Schrems I & Schrems II ,
Standard Contractual Clauses