Pamela Del Negro

Pamela Del Negro

Pamela H. Del Negro is a member of Robinson+Cole’s Health Law Group, where she advises institutional providers, including hospitals and ambulatory surgery centers, as well as physician practice groups, community providers, and other health care entities on health care issues and general corporate matters. She provides legal counsel on a full range of transactional and regulatory health law issues, including co-management arrangements; compliance plans; the acquisition and merger of medical entities; Medicare and Medicaid fraud and abuse and the Stark law; hospital affiliations; the privacy and security of personal health information; corporate governance; private placements; and contracting. She also works with clients on managed care contracting, the corporate practice of medicine issues, clinical integration and antitrust issues, and the structuring and acquisition of electronic health records technology, including the negotiation and documentation of software agreements. Read her full bio here.

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Supreme Court Decision Allows Faster Marketing of Biosimilars

On Monday, June 12, 2017, the United States Supreme Court in a unanimous decision held that manufacturers making biosimilars of biologic drugs did not have to wait until after gaining federal approval of the biosimilar to notify the manufacturer of biologic reference products (Sponsor) that they intend to commercially market a biosimilar drug. The Court’s decision addresses two cases in the same opinion: Sandoz v. Amgen and Amgen v. Sandoz. …

NJ Gov. Chris Christie Seeks to Ease HIPAA Restrictions in Cases of Opioid Overdose

Last week, New Jersey Governor Chris Christie told reporters that he is in talks with representatives from the U.S. Department of Health and Human Services and the U.S. Department of Justice about easing HIPAA restrictions in situations where individuals have experienced an opioid overdose. Gov. Christie chairs the presidential commission on opioid abuse. Speaking to reporters, Gov. Christie expressed an interest in letting “parents and loved ones know when people have been reversed with Narcan,” referring to a prescription medicine that can be used to reverse an overdose. HIPAA generally …

Recent OCR Settlements

The Office for Civil Rights (OCR) recently announced settlements with healthcare-related entities, including:

  • The OCR entered into a settlement with The Center for Children’s Digestive Health (CCDH) for $31,000.  CCDH is a small for-profit health care provider with seven locations in Illinois. The settlement arose out of an OCR compliance review initiated in August 2015 after an investigation of a CCDH business associate that stored inactive paper medical records for CCDH.  While CCDH had been disclosing PHI to the vendor since 2003, neither party could produce a business associate agreement

Joint Commission Bans Secure Text Messaging for Patient Care Orders

The Joint Commission recently clarified that patient care orders may not be transmitted by secure text message.  The Joint Commission initially prohibited the practice in 2011 but subsequently allowed practitioners to send orders through a secure text messaging system if certain conditions were met.   In this most recent clarification, The Joint Commission states that concerns remain even when using secure messaging platforms.

The clarification includes several recommendations developed by The Joint Commission in cooperation with the Centers for Medicare & Medicaid Services (CMS).  In addition to the ban on secure …