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OIG Reports that Clinical Trials Lack Diverse Subjects: What Role Can Artificial Intelligence Play?

As the largest public funder of biomedical research in the world, the National Institutes of Health (“NIH”) annually funds over $38 billion in extramural research, including about $6 billion for clinical trials. On May 28,...more

HHS Seeks to Remove Silos and Unleash Patient Data with Final Patient Data-Sharing Rules

On March 9, 2020, the Centers for Medicare and Medicaid Services ("CMS") and the Office of the National Coordinator for Health Information Technology ("ONC") each released final rules generally intended to ease both access to...more

The New SHIELD Act Changes Breach Notification Rules and Data Security Standards for New Yorkers' Personal Information

Reflecting the movement to toughen data security laws on a state-by-state basis, on July 25, 2019, Governor Cuomo signed into law the Stop Hacks and Improve Electronic Data Security Act (the "SHIELD Act" or the "Act"). The...more

Laptop Security Breach Leads to $850,000 HIPAA Settlement Payout

On November 19, 2015, Lahey Hospital and Medical Center (“Lahey”) entered into an $850,000 settlement with the U.S. Department of Health and Human Services (“HHS”), Office for Civil Rights (“OCR”) for alleged violations of...more

Attorney General Issues Guidance On State Not-for-Profit Law

On April 13, 2015, the New York Attorney General’s office released two guidance documents addressing key provisions of the New York Not-for Profit Corporation Law (the N-PCL) enacted as part of the Non-profit Revitalization...more

Responding to the Anthem Cyber Attack

Anthem Inc. (Anthem), the nation's second-largest health insurer, revealed late on Wednesday, February 4 that it was the victim of a significant cyber attack. According to Anthem, the attack exposed personal information of...more

New York Nonprofit Revitalization Act Rollout Challenges

As the July 1, 2014 compliance date of the New York Nonprofit Revitalization Act of 2013 (the "Revitalization Act") quickly approaches, many charities operating in New York are confronting some difficult rollout challenges....more

OIG Issues Special Fraud Alert on Business Arrangements with Physician-Owned Entities

On March 26, the HHS Office of Inspector General (OIG) issued a Special Fraud Alert (Fraud Alert) reiterating its long-standing concern that the opportunity for a referring physician to earn a profit by investing in a venture...more

HHS Issues HIPAA/HITECH Omnibus Final Rule Ushering in Significant Changes to Existing Regulations

"Sweeping changes" is how Leon Rodriquez, of the Department of Health and Human Services Office of Civil Rights (OCR), characterized the effect of the final omnibus Health Insurance Portability and Accountability Act (HIPAA)...more

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