On January 6, 2025, the US Food and Drug Administration (FDA) and the US Department of Health and Human Services (HHS) Office for Human Research Protections (OHRP) released a joint draft guidance document: Considerations for...more
Early in the new year, the US Food and Drug Administration (FDA) released two anticipated draft guidance documents focused on artificial intelligence (AI): Artificial Intelligence-Enabled Device Software Functions: Lifecycle...more
2/24/2025
/ Artificial Intelligence ,
Automated Decision Systems (ADS) ,
Data Management ,
Data Privacy ,
Food and Drug Administration (FDA) ,
Healthcare ,
Labeling ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Risk Assessment ,
Risk Management ,
Technology
On December 16, 2024, the US Department of Health and Human Services (HHS) Assistant Secretary for Technology Policy/Office of the National Coordinator for Health Information Technology (ASTP) published the Health Data,...more
In a consequential decision for Health Insurance Portability and Accountability Act (HIPAA)-regulated entities, on June 20, 2024, the US District Court for the Northern District of Texas ruled in American Hospital Association...more
YOUR SOURCE FOR SUCCESS IN PHARMA AND DEVICE SERVICES INVESTING -
Join C-suite executives, senior private equity professionals, investment bankers and other industry leaders for a deep dive into the investment...more
4/19/2024
/ Acquisitions ,
Biopharmaceutical ,
Biotechnology ,
C-Suite Executives ,
CEOs ,
Clinical Trials ,
Events ,
Health Care Providers ,
Health Technology ,
Innovation ,
Investment Banks ,
Investment Funds ,
Investment Opportunities ,
Investors ,
Med Tech ,
Medical Devices ,
Mergers ,
Pharmaceutical Industry ,
Private Equity ,
Private Equity Firms ,
Private Equity Funds ,
Regulatory Requirements ,
Research and Development ,
Supply Chain ,
Venture Capital
On October 30, 2023, the White House released a long-awaited Executive Order (EO) on the “Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence.” The EO acknowledges the transformative potential of AI...more
11/1/2023
/ Artificial Intelligence ,
Biden Administration ,
Data Security ,
Executive Orders ,
Healthcare ,
Healthcare Reform ,
Innovative Technology ,
Legislative Agendas ,
New Legislation ,
New Regulations ,
Privacy Laws ,
Regulatory Agenda ,
Regulatory Requirements ,
Technology
Online tracking technologies, such as pixels, have become a common feature of the modern web and app ecosystem. Pixels and other online tracking technologies may be configured to collect user data about website visits,...more
9/25/2023
/ Data Collection ,
Data Privacy ,
Data Protection ,
Data Security ,
Department of Health and Human Services (HHS) ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Information Technologies ,
Health Insurance Portability and Accountability Act (HIPAA) ,
Online Platforms ,
Regulatory Requirements ,
Technology Sector ,
Web Tracking ,
Websites
On August 15, 2023, the US Food and Drug Administration (FDA) finalized Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors (final guidance). This document finalizes, with new examples and limited...more
9/6/2023
/ Clinical Trials ,
Coronavirus/COVID-19 ,
Food and Drug Administration (FDA) ,
Healthcare ,
Informed Consent ,
IRB ,
Life Sciences ,
Medical Research ,
New Guidance ,
Pharmaceutical Industry ,
Regulatory Requirements ,
Scientific Research
Life sciences organizations have become some of the world’s most watched businesses and the industry as a whole is facing heightened scrutiny in light of the COVID-19 pandemic.
The transactional and regulatory issues as...more
You won’t want to miss four days of exclusive, virtual events that bring together industry leaders, emerging standouts, innovators and investors from across the industry landscape at the largest healthcare investment...more
1/6/2021
/ Business Development ,
Business Disruption ,
Business Strategies ,
Collaboration ,
Coronavirus/COVID-19 ,
Digital Health ,
Funding Arrangements ,
Health Care Providers ,
Health Technology ,
Healthcare Facilities ,
Hospitals ,
Innovation ,
Investors ,
Legislative Agendas ,
Life Sciences ,
Physicians ,
Private Equity ,
Regulatory Requirements ,
Webinars
The COVID-19 pandemic has changed the way we do almost everything, accelerating the use of artificial intelligence (AI) and new technologies, and creating vast new troves of sensitive personal information. Yet the question...more
12/1/2020
/ Artificial Intelligence ,
Coronavirus/COVID-19 ,
Data Collection ,
Data Privacy ,
Data Protection ,
Data Security ,
Data Use Policies ,
Data-Sharing ,
Privacy Laws ,
Regulatory Requirements ,
Sensitive Personal Information ,
Transparency ,
Webinars