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Trending in Telehealth highlights monthly state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and...more
Companies depend on regulatory guidance to establish robust compliance programs but recent withdrawals of key antitrust guidelines are leaving businesses in a guideless void. What Happened - The US antitrust agencies...more
There could be an all-you-can-eat buffet of regs (and eggs) from now until the end of the year! As you may recall, a July 2024 Regs & Eggs blog post highlighted the spring 2024 “unified agenda” that listed all the regs...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists, and technology companies that deliver and facilitate...more
This summer, the U.S. Supreme Court overruled the Chevron deference in a 6–3 decision, holding that “Courts must exercise their independent judgment in deciding whether an agency has acted within its statutory authority.” As...more
Human Factors and User Experience testing play an important role in healthcare settings and in the development of healthcare products. They can greatly impact the delivery of care, and the patient experience delivered by...more
On September 29, California Governor Gavin Newsom vetoed SB 1047, one of the most ambitious efforts yet to establish a comprehensive artificial intelligence (AI) regulatory framework in the United States. But for all of the...more
Trending in Telehealth highlights state legislative and regulatory developments that impact the healthcare providers, telehealth and digital health companies, pharmacists and technology companies that deliver and facilitate...more
On June 17, 2024, the U.S. Food and Drug Administration’s (FDA) Digital Health Center of Excellence (DHCE), published a blog article highlighting the promise of artificial intelligence (AI) in healthcare. In the article, the...more
Exiting a business, whether you are a serial entrepreneur looking to move on to the next project or a healthcare provider like a physician or therapist who has nurtured your practice for decades, can be difficult. After all,...more
On April 22, 2024, the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services announced final regulatory updates to the Privacy Rule under the Health Insurance Portability and Accountability Act of...more
Where has the time gone? We have hit the one-year mark since the end of the COVID-19 public health emergency (PHE). Yes, you read that correctly. One year! One of the long-term consequences of the PHE was the shift in when...more
Part II of our New Jersey Regulatory Update further identifies proposed and adopted regulations that may impact healthcare providers, from additional financial transparency rules impacting facilities to rules attempting to...more
It is that time of year for our regulatory update. Parts I and II will discuss proposed and adopted rules from the second half of last year to the first quarter of this year that impact healthcare providers in New Jersey,...more
In October 2023, the International Organization for Standardization (ISO) published ISO 7101, Healthcare organization management: Management systems for quality in healthcare organizations. ISO 7101 is the latest in a series...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
The World Trade Organization (WTO) Committee of Participants on the Expansion of Trade in Information Technology Products (ITA Committee) meets on April 11. The committee holds regular meetings twice a year to review...more
The U.S. Department of Health and Human Services Office of Inspector General (HHS OIG) released an important new compliance resource in November 2023. The HHS OIG’s new General Compliance Program Guidance (GCPG) is intended...more
Since early 2022, the Idaho legislature has modified the standards for a patient’s capacity to consent to healthcare and 24-hour protective holds. This health law update summarizes the current rules for capacity and consent;...more
On Oct. 30, President Joe Biden issued an executive order on safe, secure and trustworthy artificial intelligence. The executive order provides a sprawling list of directives aimed at establishing standards for AI safety...more
On October 23, 2023, FDA published a draft guidance document to provide detailed recommendations to industry regarding the communication of unapproved uses of approved or cleared drugs and medical devices to health care...more
The European Medicines Agency (EMA) published Version 1.1 of its “Guidance on how to approach the safeguarding of personal protected data (“PPD”) and commercially confidential information (“CCI”) while using the Clinical...more
South Dakota - The South Dakota Division of Insurance (“Division”) recently took regulatory action against a TPA that has held a valid TPA registration in South Dakota since 2006. In 2021, the TPA submitted its TPA...more
In an important decision limiting the reach of the Federal Anti-Kickback Statute (42 U.S.C. 1320a-7b(b)) (“AKS”) and its application to violations of the False Claims Act (31 U.S.C. 3729, et seq.) (“FCA”), the U.S. Court of...more