Health Care Counsel Blog

The California Privacy Rights and Enforcement Act (CPRA) has qualified for the November 3, 2020 ballot, according to a recent update by the California Secretary of State’s office.

Headlines that Matter for Companies and Executives in Regulated Industries

Pharmaceutical manufacturers and other stakeholders should submit comments on the Proposed Rule by July 20, 2020.

The FDA has just issued a Guidance on what it considers to be appropriate Current Good Manufacturing Practices (CGMPs) for Responding to COVID-19 infections in employees in drug and biological manufacturing facilities. 

On June 15, 2020, the owner of several information technology companies was charged in a criminal complaint with bank fraud and for making false statements to a financial institution. 

FDA’s website allows you to determine if a particular COVID-19 test has been reviewed by the FDA.

Headlines that Matter for Companies and Executives in Regulated Industries

Health Care Practice Group Co-Leader Douglas Grimm was recently quoted in a Healthcare Dive article.

On May 26, 2020, a Magistrate Judge in the US District Court for the Eastern District of Virginia ordered Capital One to turn over a digital forensic investigation report in a class action arising out of a 2019 cyber incident affecting roughly 100 million US residents.

Headlines that Matter for Companies and Executives in Regulated Industries

Health Care partner Thomas Jeffry was recently quoted in a Healthcare Risk Management article titled “COVID-19 Changes HIPAA Compliance, But Caution Necessary.”

Confirming decades of established precedent, the California Supreme Court recently concluded in Nationwide Biweekly Administration, Inc. v. Superior Court of Alameda County, that there is no right to a jury trial in Unfair Competition Law (UCL) or False Advertising Law (FAL) actions.

Join Jeff Blake, Managing Partner of Federal Compliance Solutions, and Stephanie Trunk, Health Care Partner at Arent Fox, for a Government Pricing & Pharmaceutical Reimbursement Office Hour.

Across the country, health care providers have struggled during the COVID-19 pandemic in the face of declining revenue and increased expenses.

Health Care Partner Anne Murphy was recently quoted by Bloomberg Law in an article titled “Hospitals Walk Legal Tightrope as Workers Speak Out on Virus.”

Headlines that Matter for Companies and Executives in Regulated Industries

Accredited organizations should begin to prepare for the resumption of survey activity in a modified form. Organizations that are experiencing a COVID-19 surge or have other challenges may want to reach out to the accrediting organization to discuss the impact of survey activity at this time.

A HHS Final Rule for Exchange plans states that coupons and copay cards offered directly by drug manufacturers can be counted towards a patient’s annual cost-sharing limit.

Health Care partner Anne Murphy will present during the 2020 American Health Law Association’s (AHLA) In-House Counsel Program.

Rachel Hold-Weiss will present during the 2020 American Health Law Association’s (AHLA) Annual Meeting. Rachel’s presentation “Hindsight is 2020: A Look at Home Health and Hospice in the New Decade,” focuses on compliance and regulatory issues for home health and hospice providers.

In what has been considered a huge win for community pharmacists, the Department of Health and Human Services (HHS) Office of the General Counsel (OGC) issued an Advisory Opinion on May 19, 2020.

Headlines that Matter for Companies and Executives in Regulated Industries

On May 12, the California Department of Consumer Affairs (DCA) issued an Order Waiving Restrictions on Pharmacists Ordering and Collecting Specimens for COVID-19 Tests, under the authority of California Governor Newsom’s March 30 Executive Order.

Stephanie Trunk will present during the ABA International Law Section’s 2020 virtual annual meeting. She will discuss how different jurisdictions address consumers’ demand for affordability of prescription drug and medical devices.

Headlines that Matter for Companies and Executives in Regulated Industries