Steps Your Nonprofit Can Take to Mitigate Fraud Risks - Part 2
A Third Party's Perspective on Third Party Risk
Implications of the SEC Cybersecurity Disclosure Rule
Privacy Issues from Third-Party Website Tags
What's the Tea in L&E? Employee Devices: What is #NSFW?
Preparing for a Government Healthcare Audit
Tackling Credit Push Fraud: Understanding Nacha's Risk Management Package (Part Two) — Payments Pros: The Payments Law Podcast
Compliance into The Weeds: The Complexity of Risk Assessments
Behavioral Health Compliance
The Importance of Assessment Areas
RegFi Episode 8: The Technological Path to Outcomes-Based Regulation with Matt Van Buskirk
What Physicians Need to Understand About Balance Billing
What Nonprofit Board Leadership Needs To Know About Internal Investigations
Taking a Behavioral Approach to Compliance
Episode 291 -- Interview of Mary Shirley on Her New Compliance Book
ChatGPT Risks for Compliance Programs
Season 2 Episode 3 - The Role of Ethics and Compliance Programs in International Business
In the Boardroom With Resnick and Fuller - Episode 4
What Non-Financial Institutions Need to Know About Gramm-Leach-Bliley
"Board-er" Patrol in Privacy and Cyberattacks - Unauthorized Access Podcast
Abiomed, Inc., a subsidiary of Johnson & Johnson, is facing lawsuits across the country related to the company’s Impella heart pumps. Since June of last year, the company has issued multiple recalls for these implantable...more
On June 13, in Culver City, twelve founders and over two dozen investors and experts convened for Project W's Women Entrepreneurs Boot Camp | Health Tech to drive innovation that is transforming the delivery of healthcare and...more
As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more
On May 21, 2024, the European Union finalized the adoption of the groundbreaking EU Artificial Intelligence Act, a comprehensive and sector-agnostic legislation that extends globally. This 420-page Act aims to regulate the...more
Medical devices that contact the human body undergo biocompatibility safety assessments prior to market release, including tests for physiochemical properties. The Food and Drug Administration’s (FDA) Center for Devices and...more
The U.S. Senate and the U.S. House of Representatives are both considering legislation that could have a serious impact on the ability of U.S. biotechnology, drug, and medical device companies to do business with...more
The following is a summary of selected federal Department of Health and Human Services’ Office of Inspector General (OIG) reports of fraud and abuse enforcement activity across the country. The enforcement actions reported...more
On November 6, 2023, the U.S. Department of Health and Human Services Office of Inspector General (“OIG”) issued its anticipated General Compliance Program Guidance (“GCPG”) for the health care industry. The GCPG serves as a...more
A new battle is emerging in the fight for health equity, and it’s centered on the humble pulse oximeter. On November 1, 2023, 25 state attorneys general sent a letter to the Food and Drug Administration (FDA) demanding that...more
Cybersecurity is a top concern for all industries, particularly for the pharmaceutical and medical device industries. These industries hold some of the most sensitive data and highly valuable technology, making them prime...more
Medical device cybersecurity continues to create buzz, as the FBI issues a Private Industry Notification to health care providers outlining cybersecurity risks for medical devices. This follows FDA’s released Draft Guidance...more
Artificial intelligence (AI) is expanding into more industries (often in surprising ways) and has inevitably caught the attention of federal and state regulators. Our Privacy, Cyber & Data Strategy Team summarizes the...more
Even though they are still quoted, statements in Medtronic v. Lohr, which question whether FDA (Food & Drug Administration) medical device clearance is a judgment about a device’s safety, no longer accurately describe what...more
Hear about the latest in research compliance - Do you want to learn… - How to prepare for upcoming changes in Medicaid? - Ways to build and maintain a better research compliance work plan for your program? - How...more
Report on Patient Privacy 22, no. 1 (January, 2022) - As the COVID-19 pandemic enters its third year, real “security fatigue” with pandemic-related issues will combine with cybercriminals’ increasingly sophisticated...more
The European Commission adopted Implementing Regulation (EU) 2021/2226 which establishes the conditions under which instructions for use of certain medical devices subject to the Medical Devices Regulation can be provided in...more
As the collection and use of health data drastically expands, the agency issued a recent guidance to officially put health apps and connected medical devices “on notice.” On September 15, the Federal Trade Commission...more
EU Regulation on Artificial Intelligence - On April 21, 2021 the European Commission published its Proposal for a Regulation on Artificial Intelligence, the first ever legal framework on AI. With its Proposal the European...more
The European Medicines Agency (“EMA”) and the EU network of Health Technology Assessment (“HTA”) bodies are jointly reviewing a proposed framework for patient preference studies. The intention of the proposed framework is to...more
On July 10, 2020, the Food and Drug Administration (FDA or the Agency) announced plans to resume domestic facility inspections following the March 2020 suspension of most foreign and domestic facility inspections as a result...more
Many countries around the world are being forced to watch as the only tool they have to suppress COVID-19 — social distancing — causes unprecedented damage to their economies. Because suppression measures may be required...more
At the end of last week, the World Health Organisation (WHO) upgraded the global risk assessment of the novel coronavirus to "very high." This comes shortly after the United Kingdom saw its first fatality as a result of...more
Death and taxes are unavoidable. And if you create a popular product, so too are product liability lawsuits. In my practice, companies sometimes ask, “How soon after our surgical robot hits the market will we get sued?”...more
The EU Medical Device Regulation goes into application on 26 May 2020, with the In Vitro Diagnostic Medical Device Regulation set to follow on 26 May 2022. These new Regulations bring sweeping changes to the market clearance...more
On January 7, 2020, the Director of the US Office of Management and Budget (OMB) issued a Draft Memorandum (the Memorandum) to all federal “implementing agencies” regarding the development of regulatory and non-regulatory...more