A U.S. Department of Health and Human Services (“HHS”) administrative law judge (“ALJ”) ordered the University of Texas MD Anderson Cancer Center (“MD Anderson”) last month to pay a $4,348,000 civil monetary penalty because of violations of the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”).  While the vast majority of enforcement actions taken

Commissioner Scott Gottlieb of the U.S. Food and Drug Administration (“FDA”) stole the spotlight this past month when he delivered a speech discussing big promises from the agency regarding artificial intelligence (“AI”) in healthcare. “One of the most promising digital health tools is artificial intelligence, particularly efforts that use machine learning,” said Gottlieb when explaining

The U.S. Food and Drug Administration’s (FDA’s) Center for Devices and Radiological Health (CDRH) recently issued its Medical Device Safety Action Plan:  Protecting Patients, Promoting Public Health (Action Plan), an aspirational set of goals concerning the agency’s approach to medical device safety.  This Action Plan can be considered the FDA’s attempt to reorganize its toolbox

On April 24, the Center for Medicare and Medicaid Services (“CMS”) made major changes to the electronic health record (“EHR”) Meaningful Use Program.  Issued as part of a proposed rule updating the Medicare Inpatient Prospective Payment System and Long-Term Care Hospital Prospective Payment System requirements, these changes will significantly shift an important program that helped

On April 4, 2018, the New Jersey Attorney General’s office announced a settlement with a large network of physicians affiliated with medical and surgical practices throughout New Jersey (the “Medical Group”) for health privacy and security violations related to a breach of more than 1,650 patient records.  The settlement for violations of the federal Health

On February 28, Ethan Davis, the U.S. Department of Justice’s (DOJ) deputy assistant attorney general responsible for consumer protection, gave a speech discussing the Department’s plans for enforcement of laws governing the marketing of medical products. Mr. Davis highlighted recent DOJ enforcement actions and previewed how the Department intends to approach the issue in the

Digital health companies continue to forge ahead with plans to delve into the medical cannabis industry, despite uncertainty surrounding the legal status of medical cannabis at the federal level.

On March 1, 2018, Revive Therapeutics Ltd. (“Revive”), a Toronto-based company focused on the research, development, and commercialization of novel cannabinoid solutions, announced that it has

Under the HIPAA Breach Notification Rule, Covered Entities must report to the Secretary of the U.S. Department of Health and Human Services (HHS) breaches of unsecured protected health information  affecting fewer than 500 individuals (“small breaches”) no later than 60 days after the end of the calendar year in which the breaches were discovered. This

Late last week, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) announced a $3.5 million settlement with a large provider of kidney dialysis services (the “Provider”) for multiple violations of the Health Insurance Portability and Accountability Act and its associated regulations (HIPAA).  In early 2013, the Provider filed five separate

  • Draft guidance documents propose a framework for clinical and patient decision software and explain policy changes driven by 21st Century Cures Act
  • Final guidance document adopts International Medical Device Regulators Forum principles for addressing “clinical evaluation” of Software as Medical Device
  • Public Workshop (January 2018) will discuss progress of pilot precertification program

The FDA’s December 8 announcement of the availability of three new guidance documents, and of a public workshop to be held in January 2018, demonstrates the agency’s commitment to prioritizing the development of digital health software policy. As we previously reported here, Commissioner Gottlieb made it the subject of his first public statement and shortly afterward led the FDA’s rollout of a framework – the Digital Health Innovation Action Plan – for ensuring that its policies enable innovators to efficiently deliver safe and effective digital health technologies to patients and consumers. The publication of these documents and announcement of the workshop fulfill a few of the ambitious promises contained in the agency’s Action Plan.


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