Taking the Pulse, A Health Care and Life Sciences Video Podcast | Episode 243: HIPAA Compliance and Potential Changes with Shannon Lipham of Maynard Nexsen
Key Discovery Points: Don’t Get Caught with Your Hand in the Production Cookie Jar
New Developments in Health Information Policy
New HIPAA Final Rule: Key Changes to Reproductive Health Care Privacy - Thought Leaders in Health Law®
Podcast - Data Privacy and Tracking Technology Compliance
Medical Device Legal News with Sam Bernstein: Episode 10
AI Risks in Healthcare
Business Associates Here, There, and Everywhere: When Does Your Service Provider Really Need to Sign a HIPAA Business Associate Agreement?
Healthcare Privacy Walkthroughs
Dobbs on Demand: Healthcare Privacy on the Line in a New Legal Setting
HIPAA Tips With Williams Mullen - Health Care Providers - Are You Ready for a Ransomware Attack?
Hybrid Workforces and Compliance with Sheila Limmroth
Privacy and Healthcare Business Associates with Isabella Porter
Podcast: Interoperability: The Provider Perspective - Diagnosing Health Care
HIPAA Tips With Williams Mullen - COVID Health Information and HIPAA – Do You Know the Rules?
Podcast–Interoperability: How Far We’ve Come and Where We’re Going - Diagnosing Health Care
State Law Privacy Video Series | Healthcare Entities and Health Data
Getting Personal—Wearable Devices, Data, and Compliance
AGG Talks: Technology - In the Balance: Interoperability and Security
Podcast: How Can Companies in the Health Care and Life Sciences Industries Strengthen Their Cybersecurity Posture? - Diagnosing Health Care
Drug and device manufacturers are increasingly targeted by cyber threats that can compromise patient safety, intellectual property, and other critical data and systems, while also facing new regulatory demands. As regulators...more
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
Join Gardner Law for a half-day CLE event in person at the Capital Factory in Austin, TX or attend virtually. Prepare for the regulatory rodeo with confidence by learning how to navigate regulatory, compliance, and privacy...more
The Food and Drug Administration (FDA) has issued a final rule, Institutional Review Board Waiver or Alteration of Informed Consent for Minimal Risk Clinical Investigations, which allows an exception from the requirement to...more
Key players across the healthcare industry—including sponsors, contract research organizations (CROs), research sites, regulators and patient advocates—are well aware of the challenges associated with the prompt and effective...more
As the life sciences industry continues to expand and grow increasingly complex, so does its legal, regulatory, and compliance landscape. To help companies and investors navigate the many evolving and emerging laws and...more
A mobile application developer of ovulation and period tracking software agrees to pay civil penalties and 20 years of independent monitoring for violating the Health Breach Notification Rule for sharing sensitive personal...more
Privacy Briefs: June 2023 - Long-term care pharmacy network PharMerica disclosed a breach involving more than 5.8 million patients, making it the largest breach reported to the HHS Office for Civil Rights (OCR) in the last...more
The US Department of Health and Human Services recently updated its guide to help the private and public healthcare sectors develop cybersecurity protocols that address NIST’s Framework for Improving Critical Infrastructure...more
The use of telehealth continues to grow rapidly across the U.S. Given legislative proposals and the Centers for Medicare & Medicaid Services efforts to expand access to telehealth, we can only anticipate that remotely...more
In 2019, U.S. Department of Justice (DOJ) enforcement activity targeting drug and device manufacturers jumped sharply over the prior year, reflecting an increased focus on fraud and abuse in the life sciences sector. More...more
On January 6, 2020, the California State Senate’s Health Committee unanimously approved California AB 713, a bill that would amend the California Consumer Privacy Act (CCPA) to except from CCPA requirements additional...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. Department of Health and Human Services on Dec. 28, 2018, announced the release of the "Health Industry Cybersecurity Practices: Managing Threats and Protecting Patients" that provides a "Call to Action" to make...more
The U.S. Food and Drug Administration (FDA) recently issued a dense, 24-page draft guidance, titled "Content of Premarket Submissions for Management of Cyber Security in Medical Devices" (the guidance). The guidance notes...more
From insulin pumps and pacemakers to defibrillators, medical devices increasingly rely on wireless and internet connectivity for efficient operations. Unfortunately, these interconnections also leave devices vulnerable to an...more
Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more
New York AG Settles Data Protection Enforcement Against Mobile Health Apps - After a year-long investigation into mobile health apps claiming to be able to measure vital signs or health indicators through smartphone...more
On December 13, 2016, President Obama signed the 21st Century Cures Act ("Cures Act"), H.R. 34, into law. It enjoyed bipartisan support and was overwhelmingly approved by the House and Senate in recent weeks. The expansive...more
Tongue-in-cheek references to Pokémon Go as a health App aside, maybe the tech industry is on to something. In the U.S., seven out of every ten deaths are due to chronic diseases, such as diabetes or heart disease. Perhaps...more
With expenditures of over $ 3 trillion of market in the field of health care in the United States is huge. Incentives of the Federal Government for the introduction of electronic medical records resulted increasingly in the...more
As regulators seek to define their authority and the scope of their enforcement power, more health apps will continue to flood the marketplace and transform how patients are treated. As mobile health applications...more
While attending the International Association of Privacy Professionals annual global event, and listening to Chairwoman Edith Ramirez discuss the Federal Trade Commission’s (FTC) concerns about consumer privacy, the FTC, the...more
I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more
Digital health is a growing field that promises improved patient education, wellness, engagement, access to care, and outcomes, among other things. However, with these new technologies come unique regulatory concerns that...more