Biography

As Chair of the firm's Health Care & Life Sciences Group, Andrew provides regulatory and compliance advice to a broad range of clients in the health care and life sciences industries, including hospitals, academic medical centers, and related providers as well as pharmaceutical, medical device, and biotechnology companies.

While Andrew's practice is broad and encompasses many different legal areas within the health care and life sciences space, Andrew has particular experience with respect to the following types of matters: hospital and payer affiliations, including negotiations of affiliation agreements, revisions to governance documents, regulatory approvals, and diligence matters; the formation and operation of accountable care organizations (ACOs), physician-hospital organizations (PHOs), independent practice associations (IPAs), and related multi-provider networks; compliance with the federal anti-kickback statute, Stark law, and other fraud and abuse laws such as in the context of product discount arrangements, relationships with physicians, and health care transactions; the European Union General Data Protection Regulation (GDPR) and HIPAA, HITECH, and state privacy laws including the development of comprehensive privacy and security policies and related guidance documents; and the conduct of human subjects research and related issues, both domestically and internationally.

Andrew has gained a strong understanding of the operational aspects and business of pharmaceutical and device companies through prior on-site placements at three different companies. In these positions, Andrew advised clients on various legal issues including fraud and abuse laws, clinical trials and related issues (e.g., privacy, subject recruitment, site contracting, informed consent forms, and FDA requirements for INDs), market research, promotional review activities, patient assistance programs, group purchasing organization and customer contracts, discount and pricing arrangements, sales representative contracts, and state manufacturer conduct and disclosure laws including on FDA regulations and other requirements related to these activities.

In order to prepare for advising clients on the complex ethical issues involved with human subjects research, Andrew earned a Master of Bioethics from the University of Pennsylvania Center for Bioethics while he was in law school.

Services/Industries

Education

  • University of Pennsylvania Law School  (J.D., cum laude)
  • University of Pennsylvania School of Medicine  (M.BE.)
  • Bowdoin College  (A.B., magna cum laude)
    • Phi Beta Kappa

Public Service

  • Brigham and Women's Hospital Institutional Review Board, Community Member (2010-2015)

Bar Admissions

  • Massachusetts

Memberships

  • American Health Lawyers Association
  • Boston Bar Association
  • Healthcare Financial Management Association

Honors

  • Recognized in Chambers USA: America's Leading Lawyers for Business under Health Care
  • Listed in The Best Lawyers in America© under Health Care Law
  • Selected by peers for inclusion in New England Super Lawyers© under Health Care

To learn more about third-party ratings and rankings, and the selection processes used for inclusion, click here.

Firm Highlights

Publication/Podcast

Proposed Regulations Under the CCPA Provide Some Clarity, But Questions Remain

Earlier this month, the California Attorney General issued long-awaited proposed regulations (“Proposed Rule”) under the California Consumer Privacy Act (“CCPA”) [1] along with a Notice of Proposed Rulemaking Action and Initial Statement of Reasons...

Publication/Podcast

Updated FDA COVID-19 Guidance for Conduct of Clinical Trials

On March 27, 2020, the U.S. Food & Drug Administration (“FDA”) updated its prior guidance on the “ Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic ,” with an appendix adding a...

Publication/Podcast

Due to COVID-19, Federal Agencies Relax Requirements Regarding the Provision of Telehealth Services

In the past few days, in an effort to help keep Medicare beneficiaries healthy during the COVID-19 pandemic, key federal agencies within the U.S. Department of Health and Human Services (“HHS”) and the U.S...

Publication/Podcast

Massachusetts Final Budget: How the Act Will Affect Pharmaceutical Companies

On July 31, 2019, Governor Charlie Baker signed a $43.3 billion fiscal year 2020 budget (" General Appropriations Act "). Originating from the Conference Committee's budget, the General Appropriations Act accounts for any vetoes...

Publication/Podcast

Massachusetts Budget Update: Commonwealth Now Waiting on Governor Baker

On July 22, 2019, the Massachusetts House of Representatives ("House") and Senate Conference Committee ("Conference Committee") released the Commonwealth's $43.1 billion fiscal year 2020 budget bill (" H. 4000 "). It passed the House...

Publication/Podcast

Responsible Research During the COVID-19 Pandemic

Publication/Podcast

COVID-19: FDA Clinical Trial Guidance

On March 18, 2020, the U.S. Food & Drug Administration (“FDA”) published guidance for clinical trial sponsors, investigators, and institutional review boards (“IRBs”) on conducting clinical trials in the midst of the COVID-19 pandemic...