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Welcome to Vital Signs, a curated compilation of the latest legal and regulatory developments in digital health. Our lead article reports on recent developments in the U.S. Food and Drug Administration's ("FDA") regulatory...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 Washington My Health My Data Act (the MHMD Act) was signed into law on April 27, 2023, creating new restrictions on the collection and disclosure of "consumer health data" by companies in Washington or that is related to...more
On Thursday, March 2, the FTC announced an enforcement action against BetterHelp, Inc., an online mental health counseling service, relating to claims that the company’s collection and use of consumer health data were unfair...more
On February 1, 2023, the Federal Trade Commission (FTC) filed a complaint in the U.S. District Court for the Northern District of California alleging that digital health platform GoodRx violated the FTC Act by repeatedly...more
In a groundbreaking decision, the Federal Trade Commission (FTC) announced it was diagnosing GoodRx’s use of tracking pixel codes and analytics, its digital strategy, as not only an unfair or deceptive act or abusive practice...more
On February 1, 2023, the Federal Trade Commission (FTC) reached a settlement with digital health platform GoodRx for sharing users’ personal health information with third parties without properly disclosing their data...more
Arnall Golden Gregory LLP's Food & Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community and highlights articles from members of our Food & Drug practice, as well as from...more
New Jersey Attorney General (AG) Gurbir S. Grewal announced on November 2, 2020, that his office has settled with ShopRite’s parent company, Wakefern Food Corp. (Wakefern) and two of its supermarket entities for $235,000 for...more
Report on Patient Privacy 20, no. 3 (March 2020) - As the new coronavirus, COVID-19, spreads across the United States, the HHS Office for Civil Rights (OCR) is reminding HIPAA covered entities and business associates that...more
Synopsis: HIPAA provides no federal cause of action, but alleged HIPAA violations may be remedied in state court under state negligence law....more
Lately, we have answered more and more questions from pharmaceutical clients on hubs and specialty pharmacies, and associated compliance risks. In this Bulletin, we will summarize, at a very high level, the nature of hubs and...more
Recent months have seen a rise in investors interested in acquiring physical, compounding and online pharmacies, as well as other traditional healthcare providers offering in-house pharmacy services to patients. The pharmacy...more
This is part two of a two-part series covering drug diversion In Iowa. Last week, we started with an overview of key questions and considerations when there is a drug diversion issue. ...more
In ACA International v. Federal Communications Commission, 2018 U.S. App. LEXIS 6535 (2018), the DC Circuit rejected a series of challenges to the FCC’s 2015 Declaratory Ruling brought by Rite-Aid related to the...more
On March 16, 2018, the U.S. Circuit Court of Appeals for the District of Columbia issued a groundbreaking decision in ACA Int’l v. FCC, No. 15-1211, 2018 U.S. App. LEXIS 6535 (D.C. Cir. Mar. 16, 2018) (“ACA Int’l“) that...more
It should come as no surprise to readers of this blog that the TCPA is the subject of regular criticism by judges across the country. See e.g. Dominguez v. Yahoo!, Inc., No. 13-1887, 2017 U.S. Dist. LEXIS 11346, at *20 (E.D....more
Medicaid - Florida's Medicaid Third-Party Liability Act Pre-empted by Federal Law - By Eddie Williams - In Gallardo v. Dudek, Sec. of Florida Agency for Health Care Administration, No. 4:16cv116-MW/CAS, 2017 WL...more
In an outright win for pharmacies, the U.S. District Court for the Southern District of New York, in the attached opinion, granted Rite Aid’s motion for summary judgment in a class action alleging violations of the TCPA....more
The Telephone Consumer Protection Act (“TCPA”) was enacted to protect consumers from intrusive robocalls, but Congress probably did not foresee that it would result in a windfall for plaintiff’s lawyers. Virtually every...more
The number of claims filed under the Health Insurance Portability and Accountability Act (HIPAA) have skyrocketed in recent years. The latest figures from the U.S. Department of Health and Human Services (DHS) highlight a...more
On June 30, 2015, the Governor of Connecticut signed into law S.B. 949, “An Act Improving Data Security and Agency Effectiveness." The new law updates Connecticut’s data security laws, including by adding a 90-day hard...more
On April 27, 2015, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a resolution agreement with Cornell Prescription Pharmacy (CPP) pursuant to which CPP paid a $125,000...more
In order to predict what 2015 will look like in the war against health care fraud, it is necessary to quickly review what happened in 2014. In 2014, the government’s health care fraud prevention and enforcement efforts...more
On April 22, 2015, the Office for Civil Rights (OCR) entered into its first HIPAA violation settlement in 2015. The settlement requires Cornell Prescription Pharmacy, a small pharmacy located in the Denver area to pay the OCR...more