The Regulatory Reminder

This website does not provide legal advice, nor does your review of this website's contents create an attorney-client relationship with any attorney or law firm.  Please be wary of all information you receive on the Internet, and please be especially wary where such information has any bearing on your legal rights or responsibilities.  If you have questions about laws or regulations, please consult an attorney who is licensed to review and apply them to your particular facts and circumstances. 

May 4, 2023 - A friendly reminder that the COVID-19 Public Health Emergency (the "PHE") ends in one week . . .  

The PHE—declared in response to the COVID-19 pandemic under Section 319 of the Public Health Service Act—has provided key regulatory flexibilites to the healthcare economy over the past few years.  The PHE will expire at 11:59 P.M. on May 11, 2023.  

Further details and transition guidance materials may be found on the U.S. Department of Health and Human Services' PHE resource page, available at https://www.hhs.gov/coronavirus/covid-19-public-health-emergency/index.html.

April 21, 2023 - A friendly reminder to ensure BAAs with third-party communication platforms are in place . . .  

Last week, the U.S. Department of Health and Human Services' Office for Civil Rights ("OCR") provided updated guidance to covered entities and their business associates concerning third-party communication platforms (e.g., Zoom; WebEx), which have risen to new prominence and near-ubiquity in healthcare delivery over the course of the COVID-19 pandemic.  

In particular, OCR announced that several of its Notifications of Enforcement Discretion, including as pertains to telehealth during the global coronavirus pandemic, would be coterminous with the COVID-19 Public Health Emergency ("PHE").  Among other implications, the announcement underscores that when protected health information ("PHI") is transmitted by way of such platforms, a formal business associate agreement ("BAA") should be in place, and while OCR may have previously relaxed enforcement of this requirement in light of the PHE, the agency has made clear that enforcement activities in this area will resume once the PHE expires.  

Note, however, that although the PHE expires on May 11, 2023, OCR has stated that there will be a 90-day transition period—by the expiry of which at 11:59 P.M. on August 9, 2023, covered entities, business associates and other downstream subcontractors will need to have brought arrangements into compliance.