News & Analysis as of

Health Insurance Portability and Accountability Act (HIPAA) Covered Entities Pharmaceutical Industry

Polsinelli

The 340B Rebate Pilot: Voluntary for Manufacturers, Costly for 340B Covered Entities

Polsinelli on

Key Takeaways - HRSA’s 340B rebate pilot shifts financial and operational burden to covered entities, requiring upfront drug purchases with delayed, uncertain rebate recovery....more

Seyfarth Shaw LLP

OASH Authorizes Licensed Pharmacists to Order and Administer COVID-19 Testing, Granting Federal Immunity under the PREP Act

Seyfarth Shaw LLP on

A critical aspect of the response to the COVID-19 public-health crisis in the United States is the rapid expansion of testing capabilities across the country.  Given that almost all Americans live in close proximity to retail...more

King & Spalding

HHS Issues Final Rule Requiring Disclosure of Partial Refills of Prescriptions to Help Curb Opioid Abuse

King & Spalding on

On January 23, 2020, HHS issued its final rule adopting a modification of the requirements for the use of the Telecommunication Standard Implementation Guide, Version D.0, National Council for Prescription Drug Programs...more

Arnall Golden Gregory LLP

AGG Food & Drug Newsletter - December 2016

Arnall Golden Gregory LLP's Food and Drug Newsletter is a monthly update of legal and regulatory issues that affect the FDA-regulated community, including regular updates on legislative initiatives from AGG’s Washington, DC...more

Sheppard Mullin Richter & Hampton LLP

HIPAA/HITECH Compliance Strategies for Medical Device Manufacturers

As computing power continues to become cheaper and more powerful, medical devices are increasingly capable of handling larger and larger sets of data. This provides the ability to log ever expanding amounts of information...more

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