Jennifer Tharp

Subscribe to all posts by Jennifer Tharp

FDA Issued Enforcement Discretion Measures for Infant Formula

In recognition of the infant formula crisis facing the United States supply chain, the Food and Drug Administration (“FDA”) issued guidance on May 16, 2022 providing for enforcement discretion with respect to certain requirements for infant formulas that may not comply with certain statutory and regulatory requirements. The guidance remains in effect until November 14, … Continue Reading

FDA Revokes EUAs for Certain Non-NIOSH Respirators – A Sign of More to Come?

More than a year after issuing Emergency Use Authorizations (“EUAs”) for filtering facepiece respirators (“FFRs”), surgical masks, and related personal protective equipment (“PPE”), the Food and Drug Administration (“FDA”) is walking back these measures. On June 30, 2021 the FDA announced the revocation of the EUAs for all imported, disposable FFRs not approved by the … Continue Reading

A Respite for Potential Liability for Face Masks

Since April 8, 2020, seven states (in order of adoption: New Jersey, Rhode Island, New York, Maryland, Hawaii, Connecticut and Pennsylvania) have issued executive orders (“EOs”) requiring the wearing of face masks in various situations, ranging from being in a public place where close contact may be unavoidable, riding public transportation, working or shopping at … Continue Reading

A Broad Emergency Use Authorization for Face Masks

On April 18, 2020, FDA issued a new Emergency Use Authorization (“EUA”) relating to non-surgical face masks with broad coverage and implications for recent industry participants manufacturing face masks. The EUA applies to the broad class of non-surgical face masks used to cover a person’s nose and mouth. Please see our prior blog post for … Continue Reading

Shortages of PPE Drive FDA Guidance and Emergency Use Authorizations

Background On January 31, 2020, the Secretary of the Department of Health and Human Services (“HHS”), Alex M. Azar II, declared a public health emergency due to a virus named SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2), or coronavirus, which causes novel coronavirus disease 2019 (“COVID-19”).  In the weeks following the declaration of the public … Continue Reading

Digital Health Update: Recent FDA Cyber Initiatives

The Food and Drug Administration (“FDA”) has greatly increased its activity around cybersecurity initiatives and medical devices. As we approach the end of the year, this is a great opportunity to review recent developments. FDA Medical Device Cybersecurity Guidance On October 18, 2018, the FDA published draft guidance, “Content of Premarket Submissions for Management of … Continue Reading

Unauthorized TV Cameras in Hospitals Yield Costly HIPAA Penalties of $999,000

For the second time in as many years, the Department of Health and Human Services’ Office for Civil Rights (“OCR”) entered into settlement agreements with and levied hefty fines on three hospitals that allegedly impermissibly disclosed patients’ protected health information to ABC News in the course of filming a television network documentary series.  OCR announced … Continue Reading

Recent Guidance by ONC and SAMHSA Sheds Light on Compliance Requirements for 42 CFR Part 2

In the face of the ongoing opioid crisis in the United States, the Office of the National Coordinator for Health Information Technology (“ONC”) and the Substance Abuse and Mental Health Services Administration (“SAMHSA”) recently released two fact sheets to clarify how the requirements of 42 CFR Part 2 apply in different provider contexts, including via … Continue Reading

States Increase HIPAA Enforcement

A recent blog post summarized Health Insurance Portability and Accountability Act (“HIPAA”) enforcement settlements for Virtual Medical Group (“VMG”) in New Jersey and EmblemHealth in New York that may signal a broader trend of increased state HIPAA enforcement.  Under the Health Information Technology for Economic and Clinical Health (“HITECH”) Act’s amendment to HIPAA, codified at … Continue Reading

FDA Approves Marketing of Clinical Decision Support Software for Stroke Triage in Midst of Renewed Focus on Digital Health Applications

The U.S. Food and Drug Administration (“FDA”) recently approved the Viz.Ai Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify providers of a potential stroke in their patients. In an article published March 8, 2018 as a PG Alert Email from the American Health Lawyers … Continue Reading
LexBlog