On July 9, 2025, the Federal Trade Commission (FTC) hosted a workshop focused on perceived “dangers” arising from unfair or deceptive trade practices in marketing a variety of health care services falling under the label of...more
On May 21, 2025, the Connecticut Office of the Attorney General released a statement and sent letters to Connecticut weight loss clinics, med spas, medical practices and other businesses regarding allegedly or potentially...more
6/6/2025
/ Consumer Protection Laws ,
Drug Compounding ,
Enforcement Actions ,
Food and Drug Administration (FDA) ,
Government Agencies ,
Health Care Providers ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements ,
State Attorneys General ,
Unfair or Deceptive Trade Practices
The U.S. Food and Drug Administration (FDA) recently announced final guidance for firms in the medical device and product industry titled, “Communications From Firms to Health Care Providers Regarding Scientific Information...more
1/8/2025
/ Compliance ,
Enforcement ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Final Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Labeling ,
Life Sciences ,
Medical Devices ,
Pharmaceutical Industry ,
Prescription Drugs ,
Regulatory Requirements
On December 19, 2024, the U.S. Food and Drug Administration (FDA) issued a Declaratory Order reevaluating and re-confirming that the tirzepatide drug shortage has been resolved. This order revoked and replaced FDA’s October...more
This is the fifth edition of our blog series on decentralized clinical trials DCTs. Click here to explore the series.
The COVID-19 Pandemic required the health care industry to adapt to accommodate remote patient care,...more
The Office of Inspector General (OIG) recently issued a new favorable advisory opinion regarding patient assistance programs (PAP) for 12 specific disease funds. PAPs help patients pay high cost-sharing obligations for...more
The U.S. Food and Drug Administration (FDA), in collaboration other agencies, recently published draft guidance (Guidance) on effectively presenting key information regarding informed consent in FDA-regulated clinical...more
3/15/2024
/ Clinical Trials ,
Department of Health and Human Services (HHS) ,
Draft Guidance ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Informed Consent ,
Penalties ,
Reimbursements ,
Research and Development ,
Risk Mitigation ,
Shareholders
On October 23, the U.S. Food and Drug Administration (FDA) issued draft guidance, Communication from Firms to Health Care Providers Regarding Scientific Information on Unapproved Uses of Approved/Cleared Medical Products on...more
On October 10, 2023, the U.S. Food and Drug Administration (FDA) issued a public warning regarding the potential health risks associated with compounded ketamine products. This warning follows a February 16, 2022 alert...more
In the third edition of our blog series on decentralized clinical trials (DCTs), we address U.S. Food and Drug Administration’s (FDA) expectations of Sponsors with respect to DTCs as articulated in the recently released draft...more
On September 27, 2022, the Food and Drug Administration (FDA) issued its much anticipated final guidance for industry and FDA Staff, Clinical Decision Support Software. This guidance follows the draft Clinical Decision...more
In this second installment of this blog series on the No Surprises Act interim regulations (NSA) we discuss: i) notice and consent requirements for out of network providers providing services at participating health care...more
In this two-part blog series, we dive into the key points for telemedicine providers in the several hundred pages of the No Surprises Act interim regulations (NSA). The good news for the telemedicine industry is that the...more
The COVID-19 pandemic has created nothing short of a seismic shift in the delivery of health care services, especially where telehealth is concerned. Following the President issuing a proclamation that the COVID-19 outbreak...more
As the U.S. continues to struggle to make COVID-19 tests available for symptomatic and asymptomatic individuals, FDA’s position regarding COVID-19 test standards is evolving. The FDA’s pivot is possibly a response to...more
The difficulties in accessing laboratory testing and securing prompt results present continuing challenges in the fight to control COVID-19. With scarce availability, there have been some attempts to limit tests to, or...more
On June 30, 2020, PhRMA released a Statement on Application of PhRMA Code Section 2 During Emergency Periods, which recognizes the difficulty in complying with the Code’s requirement that informative presentations given to...more
On March 23, 2020, the New York State (NYS) Department of Health issued updated guidance regarding use of telehealth by Medicaid providers, Comprehensive Guidance Regarding Use of Telehealth including Telephonic Services...more
4/1/2020
/ Centers for Medicare & Medicaid Services (CMS) ,
Coronavirus/COVID-19 ,
Department of Health and Human Services (HHS) ,
Emergency Response ,
Health Care Providers ,
HIPAA Privacy Rule ,
Medicaid ,
Medicare ,
State of Emergency ,
Telehealth ,
Telemedicine ,
Waivers
On March 15, 2020, in response to the a state of emergency due to the outbreak of the 2019 novel Coronavirus (COVID-19), Massachusetts Governor Charlie Baker executed an Order Expanding Access To Telehealth Services And To...more
Massachusetts Governor Charlie Baker has restarted the discussion on health care cost containment in the Commonwealth with a proposed bill that contains a raft of initiatives. Foley & Lardner LLP will be addressing each of...more
Blockchain technology originated in 1991, and was conceived as a secure way to timestamp digital documents akin to how a notary timestamps physical documents. The true value lies in the fact that once stamped, the document...more
7/18/2019
/ Blockchain ,
Credentialing ,
Distributed Ledger Technology (DLT) ,
DSCSA ,
EHR ,
Electronic Medical Records ,
Food and Drug Administration (FDA) ,
Health Care Providers ,
Pharmaceutical Industry ,
Pharmacies ,
Prescription Drugs ,
Smart Contracts ,
Supply Chain ,
Technology
The Massachusetts Medicaid Program (known locally as MassHealth) issued a new All Provider Bulletin in January, setting forth new policies for certain behavioral health services delivered to MassHealth covered patients. The...more