Experienced Health Care and Privacy Partner Joins Verrill Dana’s Health Care Group
We are pleased to welcome attorney Nadine Peters to our nationally-recognized Health Care Group. Nadine comes to Verrill Dana with more than 15 years of experience as a health care and privacy attorney and focuses on clients within the health care and life sciences industries. Most recently, Nadine served...
California Consumer Privacy Act of 2018
Introduction On June 28, a new law took effect in California that gives California residents greater control over the collection and processing of their personal information. The law, called The California Consumer Privacy Act of 2018 (the “Act”), incorporates principles similar to those in the European Union’s General Data...
Federal “Right to Try”: Don’t Disregard Your State Laws Just Yet!
How Federal Preemption (or Lack Thereof) Could Influence the Use of Federal “Right to Try”
As discussed in our Alert of June 4, “Right to Try” Comes to the Federal Stage: What Stakeholders Should Do Now , manufacturers, patients, providers and IRBs are now grappling with two alternative federal pathways through which manufacturers may (but are not required) to provide investigational drugs for treatment...
“Right to Try” Comes to the Federal Stage: What Stakeholders Should Do Now
On May 30, 2018, surrounded by patients directly impacted by tragic and intractable diseases, President Trump signed into law the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act of 2017 ( S. 204 ), which had passed the Senate on August 3, 2017 and...
A Wrinkle in Common Rule Time
In an 11th hour—but nonetheless anticipated—move, the sixteen federal departments and agencies responsible for the Common Rule Final Rule that was slated to become effective tomorrow, January 19, 2018 (“Revised Common Rule”), have issued an Interim Final Rule (“ IFR ”) delaying the effective date and the general compliance...
NIH Updates Policy for Issuing Certificates of Confidentiality
On September 7, 2017, the National Institutes of Health (“NIH”) released a Notice of Changes to NIH Policy for Issuing Certificates of Confidentiality (NOT-OD-17-109) (“the Policy”). This Policy flows from the Cures Act’s changes to when and how a Certificate of Confidentiality (“Certificate”) is issued, see Pub. Law 114-255...
The 2018 Common Rule: Implementation Checklist
As many of you know, most of the provisions of the Final Rule updating the Common Rule ( “2018 Common Rule” ) will go into effect, and compliance is required, on January 19, 2018 . Notwithstanding some uncertainty with respect to the current Administration’s regulatory plans, as of now...
Early Adoption Not an Option for Research Rule Changes
Portions of Kate Gallin Heffernan’s presentation at the American Health Lawyers Association conference on legal issues affecting academic medical centers and teaching institutions were quoted in a March 15, 2017 Bloomberg Law: Medical Research Law & Policy Report article entitled “Early Adoption Not an Option For Research Rule Changes.&rdquo...
Just Under the Wire: The Final Common Rule is Here
As many of you know, the long-awaited final rule updating the Common Rule (“Final Rule”) was issued officially January 19 (after an unofficial release to the public yesterday). Like many of you, we are in the process of digesting and analyzing the new regulations and how they alter the...
If the Federal “Compassionate Use” Program is Flawed, Are State “Right to Try” Laws the Solution?
Whether or not you agree with its position, there is no denying that in its recently released report, “Dead on Arrival,” the Goldwater Institute takes a passionate stance on the current status of the federal “Compassionate Use” program and its counterpart, the increasingly vigorous state-led initiative known as the...
Bloomberg BNA Medical Research Law & Policy Report – The NFL-NIH Research Partnership: Why Congress is Worried
A recent insights article by Kate Gallin Heffernan published in BNA’s Medical Research Law & Policy Report discusses the Congressional inquiry into the National Football League’s alleged refusal to permit its $30 million previously donated by the League to the Foundation for the NIH to support research at Boston...
The Common Rule NPRM Blog Series: Part 3 – Posting of Consent Forms
The Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), proposes a new provision that would require a copy of the final version of the consent...
The Common Rule NPRM Blog Series: Part 2 – Single IRB Review
To rely or not to rely? Under the recent Notice of Proposed Rulemaking (“NPRM”) issued by the Department of Health and Human Services (“HHS”) and fifteen other federal agencies outlining changes to their existing human subject protection regulations (the “Common Rule”), this would generally no longer be a question...
Breaking News – 30 Day Extension to Common Rule NPRM Comment Period!
Earlier this morning, Health and Human Services and the fifteen other federal departments and agencies with which it is collaborating on the Common Rule Notice of Proposed Rulemaking (“NPRM”) announced that the NPRM comment period, which was scheduled to end on December 7th, will be extended for 30 days...
The Common Rule NPRM Blog Series Part 1 – Biospecimans
As we previously announced , sixteen federal agencies, including the Department of Health and Human Services (“HHS”), recently published a Notice of Proposed Rulemaking (“NPRM”) in the Federal Register outlining changes to the existing regulations protecting human subjects (the “Common Rule”). The Common Rule NPRM is the latest development...
Decision Charts to Help You Navigate the Common Rule NPRM’s Proposed Landscape of Covered Research, Exclusions, and Exemptions
In the short time since our first Client Advisory on the recently issued Notice of Proposed Rulemaking (“NPRM”) for the Federal Policy for the Protection of Human Subjects (“Common Rule”) (80 Fed. Reg. 53933 (Sep. 8, 2015)), we have been working, along with many of our clients, to map...
At Long Last, the Notice of Proposed Rulemaking for the Common Rule is Here
For those of us who work in the clinical research field, the last two days have been quite exciting. At long last, the Notice of Proposed Rulemaking for the Common Rule is here, and the field is alive with talk of the proposed changes and the various ways in...