Health Information Exchange
Worked on behalf of a client to effect statutory changes to a state law that would allow for the creation of one of the nation's first state-wide health information exchanges.
Guided multiple clients through the implementation of the revised HHS regulations (the "Common Rule"), including reviewing and revising policies and procedures, and assisting with institutional approaches to implementation.
Developed and negotiated site and coordinating center agreements in connection with a multi-site, international, National Institutes of Health (NIH)-funded study, and advised on regulatory issues related to the conduct of the study and subsequent...
Counseled a preeminent health system and academic medical center on its compliance with the European Union General Data Protection Regulation (GDPR) in relation to its clinical and research activities, including its international research studies...
Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.
(January 19, 2021) – Verrill was recently ranked third in the American Bar Association (ABA) Health Law Section's Eighth Annual Top 10 Recognition for the Northeast Region. This is the sixth consecutive year that...
While you were celebrating the New Year, Governor Baker signed Chapter 260 of the Acts of 2020, an “Act promoting a resilient health care system that puts patients first,” the result of the Legislature’s...
(February 2, 2021) – Verrill is pleased to welcome health care attorney Alicia Siani to the firm’s Boston, Massachusetts office. Siani represents clients in a wide range of regulatory issues, including HIPAA privacy matters...
As a holiday gift to providers, the U.S. Department of Health and Human Services (HHS) General Counsel recently issued a strongly worded Advisory Opinion indicating that federal law requires drug manufacturers to deliver covered...
The U.S. Department of Health and Human Services (HHS) completed its “Regulatory Sprint” by finalizing changes to regulations pertaining to two federal fraud and abuse laws. On December 2, 2020, the Centers for Medicare...
1. 340B ADR Process Established At long last, more than ten years after Congress directed it to do so, HHS has finalized an alternative dispute resolution (“ADR”) process for both providers and pharmaceutical manufacturers...