Web-based Tracking Technology and AI: HIPAA Compliance Issues for Health Care Practices
Podcast: Discussing the Implications of Healthcare Privacy Violations
Podcast: Discussing Information Blocking with Eddie Williams
Expanded Information Block Rules Go into Effect
HIPPA: Privacy & Security and Potential Rule Changes
Compliance Perspectives: Privacy Investigations in a Virtual World
Tech Podcast: Interview With Innovative Health Care Tech Company Rymedi
Effectively Marketing Your Medical and Dental Practice While Staying Legally Compliant
Compliance Perspectives: The Ethics of Data
Compliance Perspective: What's New in Healthcare Privacy
Protecting Patient Medical Records
Exploring Digitization of Health and Medical Data and Records Part One
On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more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
On September 28, California Governor Gavin Newsom signed AB-713 into law, which relaxes some of the California Consumer Privacy Act (CCPA) compliance challenges faced by the health care and life science industries — more...more
Artificial Intelligence (AI) is everywhere. At least five articles in my inbox this morning had an AI hook. And whether people are singing its praises (“AI will improve your speed, efficiency, and quality of work!”) or...more
Clinical trials have become increasingly important for pharmaceutical companies and medical device manufacturers, which are focused on collecting as much data as possible on products and devices and their adverse effects. All...more
On 23 January 2019, the European Data Protection Board (“EDPB”) issued an opinion on the interplay between the EU General Data Protection Regulation (“GDPR”) and the EU Clinical Trials Regulation (“CTR”). The CTR is not yet...more
Making individual patient-level data available for other research presents companies with challenges, but researchers and companies can take steps to minimize the risks. Originally published in Drug and Medical Device,...more
On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more
On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more
Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more