During this session, the panelists discussed the role that SMOs and dedicated clinical trial sites (Site Platforms) play within the life sciences industry, what makes them attractive to investors, and the key criteria...more
On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
7/16/2024
/ Clinical Trials ,
Comment Period ,
Diversity ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Laboratory Developed Tests ,
Life Sciences ,
Patient Privacy Rights ,
Pharmaceutical Industry ,
Prescription Drugs ,
Proposed Legislation
On April 15, 2024, the US Food & Drug Administration (FDA) announced the establishment of the Center for Drug Evaluation and Research (CDER) Center for Clinical Trial Innovation (C3TI). C3TI will serve as the central support...more
Over the past few years, the life sciences and healthcare industries have experienced a notable increase in focus and interest in decentralized clinical trials (DCTs), in which some or all of the trial-related activities...more
The US Food and Drug Administration has issued draft guidance outlining the agency’s recommendations for using real-world data from (and curating such data in) registries to support regulatory decision-making. Pharmaceutical...more
Throughout the past year, the healthcare and life science industries experienced a proliferation of digital health innovation that challenged traditional notions of healthcare delivery and payment, as well as product...more
1/29/2020
/ Anti-Kickback Statute ,
Biometric Information ,
California Consumer Privacy Act (CCPA) ,
Department of Justice (DOJ) ,
Digital Health ,
Electronic Medical Records ,
Electronic Protected Health Information (ePHI) ,
Enforcement ,
Food and Drug Administration (FDA) ,
Fraud and Abuse ,
Health Care Providers ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Regulatory Standards ,
Stark Law ,
Telemedicine
The European Data Protection Supervisor, the independent European Union authority responsible for data protection regulatory oversight, issued a preliminary opinion on data protection and scientific research. The Opinion...more
1/24/2020
/ Advisory Opinions ,
Compliance ,
Consent ,
Data Protection ,
Data Protection Authority ,
Data Subjects Rights ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Life Sciences ,
Member State ,
Personal Data ,
Scientific Research ,
The Common Rule ,
Transparency
On December 6, 2018, Commissioner Scott Gottlieb announced the FDA’s highly anticipated new strategic framework for assessing the potential use of real-world evidence (RWE) in connection with the agency’s drug and biologic...more
Introduction -
Throughout 2017, the health care and life science industries experienced a widespread proliferation of digital health innovation that presents challenges to traditional notions of health care delivery and...more
1/10/2018
/ 21st Century Cures Act ,
Artificial Intelligence ,
Biometric Information ,
Consumer Protection Act ,
Cyber Threats ,
Cybersecurity ,
Data Breach ,
Department of Health and Human Services (HHS) ,
Digital Health ,
Federal Trade Commission (FTC) ,
Food and Drug Administration (FDA) ,
Health Information Technologies ,
Health Insurance ,
Life Sciences ,
OIG ,
Privacy Policy ,
Research and Development ,
TCPA ,
Telehealth