On February 13, 2024, the US Food and Drug Administration (FDA) issued draft guidance entitled Use of Data Monitoring Committees in Clinical Trials (Draft Guidance). It provides sponsors and others involved in clinical trial...more
Following the White House’s Executive Order on the Safe, Secure, and Trustworthy Development and Use of Artificial Intelligence, on December 13, 2023, the White House announced that 28 healthcare payors and providers intend...more
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
Data governance is a mission-critical issue for every company and institution in the United States.
GCs face a host of pressing cybersecurity concerns. Triaging them requires time, attention, and a well-rounded strategy...more
8/18/2023
/ Cookies ,
Corporate Governance ,
Cybersecurity ,
Data Privacy ,
Data Protection ,
Disclosure Requirements ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Healthcare ,
Legislative Agendas ,
Mobile Apps ,
New Legislation ,
New Rules ,
OCR ,
Personal Information ,
Regulatory Agenda ,
Risk Factors ,
Risk Management ,
State Privacy Laws ,
Technology Sector ,
Tracking Systems
Remarkable progress in DNA and RNA sequencing have democratized the generation and analysis of genomic data across diverse industry sectors, including biopharmaceutical research, healthcare, consumer ancestry, law...more
On Thursday, July 20, 2023, the Federal Trade Commission and HHS Office for Civil Rights issued a rare joint press release announcing that approximately 130 hospital systems and telehealth providers received a letter alerting...more
7/24/2023
/ Data Collection ,
Data Privacy ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Enforcement Actions ,
Federal Trade Commission (FTC) ,
Health Care Providers ,
Health Information Technologies ,
Hospitals ,
Joint Statements ,
Mobile Apps ,
OCR ,
Telehealth ,
Tracking Systems ,
Websites
In this session, panelists discussed common pitfalls that life sciences companies face as they explore ways to incorporate digital-health strategies into product and service offerings, as well as approaches for successful...more
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
On June 30, 2015, the Federal Trade Commission (FTC) published “Start with Security: A Guide for Businesses” (the Guide).
The Guide is based on 10 “lessons learned” from the FTC’s more than 50 data-security...more
In This Issue:
- The President’s Plan for Securing Cyberspace
- The President’s Plan for Safeguarding American Consumers and Families
- Conclusion
- Excerpt from The President’s Plan for Securing...more
In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission...more
12/11/2014
/ Africa ,
Anti-Spam Legislation ,
Canada ,
China ,
Cybersecurity ,
Data Protection ,
EU ,
EU Data Protection Laws ,
Federal Trade Commission (FTC) ,
Latin America ,
Legislative Agendas
On May 1, 2014, the White House released two reports addressing the public policy implications of the proliferation of big data. The first report is by the Executive Office of the President, entitled “Big Data: Seizing...more
5/13/2014
/ Barack Obama ,
Big Data ,
Data Breach ,
Data Protection ,
ECPA ,
Healthcare ,
Legislative Agendas ,
Life Sciences ,
Privacy Laws ,
Privacy Policy ,
Public Policy
On January 25, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) published a final rule (Final Rule) containing modifications to the privacy standards (Privacy Rule), security...more
2/21/2013
/ Business Associates ,
Covered Entities ,
Data Breach ,
Data Protection ,
Department of Health and Human Services (HHS) ,
Enforcement ,
GINA ,
Health Insurance Portability and Accountability Act (HIPAA) ,
HITECH Act ,
Notice Requirements ,
OCR ,
PHI ,
Privacy Rule