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
We bring you Vital Signs, a curated, one-stop resource on the most notable digital health law updates from our U.S. and global contributors. In Industry Insights, we present a timely discussion about increasing litigation and...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 upcoming election, and the approaching end of the President’s four-year term, introduce additional dynamics into the agencies’ rulemaking process and even the guidance process. From now through the November election, the...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
These are exciting times for the advancement of healthcare, whether you’re a hospital, health system, or healthcare technology company or a consumer that benefits from the proliferation of products and services provided. In...more
Holland & Knight Health Dose is an in-depth weekly dose of legislative and regulatory insights to keep stakeholders abreast of happenings in Washington, D.C., impacting the health sector....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 Points: Illumina DNA sequencing machines are vulnerable to exploitation. Both the Cybersecurity and Infrastructure Security Agency (CISA) and the Food and Drug Administration (FDA) have published advisories urging all...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
In the last ten years, more data and greater computing power have led to a boom in AI-related patent applications, with life and medical sciences emerging as a top application field. In 2021, more than 100 applications...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
On December 29, 2022, President Biden signed a new statute that will significantly impact medical device cybersecurity regulation. Section 3305 of the Consolidated Appropriations Act of 2023 (“Section 3305”) authorizes the...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
In March 2023, the Federal Trade Commission announced a number of consumer protection actions involving data privacy, COVID health claims, a robocall debt relief pitch scheme, and alleged harmful noncompete restrictions. The...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
We are pleased to provide you with the third annual installment of our Life Sciences and Health Care Horizons guide. For each of these guides, we have asked our industry thought leaders throughout the world to write about...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