Podcast: Addressing Patient Complaints About Privacy Violations
Podcast - What Healthcare Providers Should Be Telling Students and Interns About HIPAA and Snooping
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 223: Cybersecurity and Privacy Risks with Healthcare Vendors with Brandon Robinson of Maynard Nexsen
Beyond the Bylaws: The Medical Staff Show - Medical Staff 101
New Developments in Health Information Policy
Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 211: Cybersecurity and Privacy Risks for the Healthcare Industry with Brandon Robinson of Maynard Nexsen
New HIPAA Final Rule: Key Changes to Reproductive Health Care Privacy - Thought Leaders in Health Law®
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
Dobbs on Demand: Healthcare Privacy on the Line in a New Legal Setting
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
Last week, the U.S. Cybersecurity and Infrastructure Security Agency (“CISA”) and the U.S. Food and Drug Administration (“FDA”) released warnings about an embedded function they found in the firmware of the Contec CMS8000,...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On June 26, 2024, the US Food and Drug Administration (FDA) released its much-anticipated draft guidance on Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies....more
On June 26, 2024, FDA issued a new draft guidance on clinical trial diversity, “Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies” (Draft Guidance), to assist...more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
The goal of value-based care (VBC) is to promote better care for individual patients and improved health outcomes for communities at reduced costs. This is an important and admirable purpose as many VBC stakeholders attempt...more
Happy 2024! The entire Saul Ewing Health Law Practice Group wishes you and yours a healthy and prosperous new year and successful (and compliant) activities in the health care delivery system this year and beyond....more
On Monday, October 24, the Food and Drug Administration (FDA) issued a new draft guidance titled, “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared...more
The FDA has been continuing to work on protecting medical devices from the threats of cybersecurity. In April of this year, the Agency released the latest draft guidance addressing cybersecurity in the medical device...more
The FDA has issued the Temporary Policy on Prescription Drug Marketing Act Requirements for Distribution of Drug Samples During the COVID-19 Public Health Emergency. The Prescription Drug Marketing Act of 1987 (PDMA)...more
Beware of “Most Favored Nations” Clauses in Commercial Contracts - Imagine that your digital health company has developed a groundbreaking product. You are eager to monetize the product, so you sign non-disclosure...more
The U.S. Food and Drug Administration took the unprecedented step this week of issuing an alert to health care providers and device manufacturers about potentially serious security flaws that may allow hackers to remotely...more
In my 25 years in the data privacy and cybersecurity profession, this is the first time that I believe a medical device has been recalled because of a cybersecurity risk. This week, Medtronic recalled its 508 Insulin pumps...more
Artificial Intelligence (AI) systems, including the use of algorithms and computer software to analyze complex data and perform certain decision making functions without direct human involvement, are rapidly developing in...more
On August 29, the FDA announced a recall of 465,000 implantable pacemakers, citing concerns that hackers may be able to take control of the pacemakers’ settings. This would open patients up to danger from improper pacing or...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
On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....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
The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more