Compliance Perspectives: The FBI on Why and How to Work with the Office of the Private Sector
The Compliance Challenge: Managing Legal & Regulatory Risk
Webinar: How to Get Your Lawyers Sharing Successfully on LinkedIn - with @AdrianDayton
Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
FCPA Compliance and Ethics Report-Episode 51-Interview with Tim Haidar
ACADEMI's Suzanne Rich Folsom and PwC's Glenn Ware on Moral Hazard
What Companies Should Do to Prepare for Implementation of Cybersecurity Executive Order
Where Does the Cybersecurity Executive Order Hit and Miss the Mark?
Cyberhackers—potentially frustrated by their limited ability to extort ransom from health care entities in attacks—have started extorting the patients themselves, threatening them with the release of information or...more
On Monday, March 11, 2024, the Office of the National Coordinator for Health Information Technology’s (ONC) Health Data, Technology, and Interoperability: Certification Program Updates, Algorithm Transparency, and Information...more
On February 8, 2024, the U.S. Department of Health & Human Services (HHS) released a final rule modifying 42 CFR Part 2 (Part 2) provisions regarding the confidentiality of Substance Use Disorder (SUD) Patient Records. The...more
After a nearly two-year delay, the U.S. Department of Health & Human Services (HHS), through the Substance Abuse and Mental Health Services Administration (SAMHSA) and the Office for Civil Rights, promulgated a Final Rule...more
In October 2023, the FDA released draft guidance entitled “Communications From Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products: Questions and Answers...more
The US Department of Health and Human Services Office of Inspector General (HHS-OIG) issued a final rule to implement its authority under the 21st Century Cures Act to investigate allegations of information blocking and...more
With minimal fanfare on a quiet summer Friday afternoon, the Federal Trade Commission (FTC) did what many have been expecting it to do for several months: it officially withdrew from two healthcare antitrust enforcement...more
On June 27, 2023, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued its long-anticipated final rule amending the OIG’s civil monetary penalty (CMP) regulations as they relate to...more
A former hospital worker in Arizona was sentenced to 54 months in prison and ordered to pay restitution after pleading guilty to two felony counts involving identity theft and health information disclosure. In the plea deal,...more
The DOJ continued its transformation of long-standing antitrust policy on February 3rd, withdrawing a slate of long-standing antitrust policy statements addressing healthcare markets and providers. The three guidance...more
On February 2, 2023, Principal Deputy Assistant Attorney General Doha Mekki announced that the US Department of Justice (DOJ) Antitrust Division was revisiting and withdrawing several policy statements that provided a key...more
Looking for compliance education and networking in your area? HCCA’s Regional Healthcare Compliance Conferences offer practitioners convenient, local compliance education, including updates on the latest news in regulatory...more
The U.S. Department of Health and Human Services (HHS) has proposed to significantly revise rules governing patient records in substance use disorder (SUD) programs, commonly known as the Part 2 rules, with important...more
For years, federal privacy laws relating to substance abuse disorder (SUD) treatment records have differed in significant ways from federal privacy laws relating to other medical records. Changes, however, are afoot. Almost...more
The DE OFCCP Week in Review (WIR) is a simple, fast and direct summary of relevant happenings in the OFCCP regulatory environment, authored by experts John C. Fox, Candee Chambers and Jennifer Polcer. In today’s edition, they...more
As of April 5, 2021, health information technology companies and developers are required to comply with the information blocking provisions of the Centers for Medicare and Medicaid Services’ (CMS) and the Office of the...more
Under the HIPAA Privacy Rule, individuals have a right to timely access their medical records at a reasonable cost. With some exceptions, a health care provider must provide those records without reasonable delay and within...more
In effort to combat the COVID-19 pandemic, we are beginning to see regulatory regimes increase the focus on data sharing with public health authorities, as well as some targeted loosening of privacy protections in the hope...more
The ONC's information blocking prohibition applies to certified health IT developers and health care providers, as well as health information exchanges and health information networks. It prohibits certain fees and other...more
In an era of decreasing reimbursement and rapidly expanding opportunities associated with “big data”, healthcare entities may be looking for ways to monetize protected health information (“PHI”) for their own, non-patient...more
The government just sent a stern reminder to all employers, especially those involved in providing healthcare, that they must still comply with the protections contained in the HIPAA Privacy Rule during the Coronavirus...more
The HHS Office for Civil Rights (OCR) issued an Important Notice Regarding Individuals’ Right of Access to Health Records through its email list serve on January 29, 2020. In the Notice, OCR addressed the recent memorandum...more
On June 28, 2018, California’s new privacy bill A.B-375 was signed into law as the California Consumer Privacy Act of 2018 (“CCPA”). On October 10, 2019, the California Attorney General issued proposed regulations for...more
Earlier this year, the federal Office of the National Coordinator for Health Information Technology (ONC) and the Department of Health and Human Services (HHS) issued proposed rules implementing the information blocking...more
SAMHSA has released a long-awaited proposed rule that would modify the federal regulations at 42 CFR Part 2 (Part 2) governing the confidentiality of substance use disorder (SUD) patient records created by federally assisted...more