Updates to Statute 1557 that Healthcare Providers Need to Know
Privacy and Healthcare Business Associates with Isabella Porter
State Law Privacy Video Series | Healthcare Entities and Health Data
Gerry Blass on Healthcare Vendor Risk Management
AGG Talks: Technology - In the Balance: Interoperability and Security
Is Your Practice's Marketing HIPAA Compliant?
Relaxed HIPAA Restrictions For Providers Using Telehealth
Compliance Perspectives: Permissible Disclosures under HIPAA, Especially in the Time of COVID-19
Polsinelli Podcasts - Confusion to Clarity on the Future of the 340B Program
Polsinelli Podcast - HIPAA Changes Overview
As the first state law to regulate the results of Artificial Intelligence System (AI System) use, Colorado’s SB24-205, “Concerning Consumer Protections in Interactions with Artificial Intelligence Systems” (the Act), has...more
On November 30, 2023, FDA announced the availability of new resources for stakeholders to facilitate compliance with the Food Traceability Rule. Refresher on FDA’s Food Traceability Final Rule - FDA issued its Food...more
340B covered entities may experience expanded access to contrast media, radiopharmaceuticals and other products at 340B prices in the coming months. Buried in the over 1,600 pages of the Consolidated Appropriations Act, 2023...more
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
Since the U.S. Food and Drug Administration (“FDA”)’s publication of the Final Rule regarding Sanitary Transportation of Human and Animal Food on April 6, 2016, 21 CFR 1.900, et seq. (the “STF Rule”), there has been an...more
This past Friday, the Office of Civil Rights within the U.S. Department of Health and Human Services published a formal Request for Information on Modifying HIPAA Rules to Improve Coordinated Care. The RFI’s publication...more
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
On June 10, 2016, the U.S. Food and Drug Administration (FDA) issued a draft guidance advising manufacturers on appropriate and responsible dissemination of patient-specific information from medical devices....more
As regulators seek to define their authority and the scope of their enforcement power, more health apps will continue to flood the marketplace and transform how patients are treated. As mobile health applications...more
Last week FDA took another important step in implementing the complex and interlocking provisions of the Drug Supply Chain Security Act (DSCSA). We have previously discussed the new Federal drug traceability requirements and...more
On August 28, 2015, the Health Resources and Services Administration (“HRSA”) published proposed Omnibus Guidance (the “Proposed Guidance”) governing policies related to section 340B of the Public Health Service Act (“PHSA”),...more
Healthcare providers would be wise to keep in mind that if a patient is harmed by a hacked medical device, Exhibit A in the negligence suit against them may be that provider’s risk analysis, or lack thereof....more
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