Informed Consent Form Templates
Developed 23 different types of global research informed consent templates for a major pharmaceutical company along with detailed negotiation guidelines for compliance with applicable laws and best practices.
Resources
ExperienceFirm Highlights
Matter
European Union GDPR—Institution
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...
Publication/Podcast
The Regulatory Sprint is Over - What’s at the Finish Line Under the New Stark and AKS Final Rules?
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...
Matter
Common Rule
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.
Publication/Podcast
HHS Confirms Providers’ Right to 340B Discount Pricing for Contract Pharmacies
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...
Matter
Conflicts of Interest
Reviewed medical center's systems, policies and procedures for identifying, assessing, and managing investigator and institutional conflicts of interest.
Publication/Podcast
Massachusetts Health Care Bill Makes Several Significant Changes
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...
Matter
Multi-Site Global Research
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...
News
Verrill Ranked in American Bar Association’s Health Law Top 10 in the Northeast
(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...
Publication/Podcast
340B Providers Get Partial Relief from New Dispute Resolution Regulation
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...
News
Verrill Welcomes Health Care Attorney Alicia Siani
(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...
