Last week, the Departments of Treasury, Labor, and Health and Human Services (the “Departments”) issued final regulations to redefine the meaning of “short-term, limited duration insurance” (“short-term insurance”). The controversial regulations are likely to expand the use of this limited
Health Law | STAT
Health Law | STAT, published by Venable LLP, focuses on legal developments and regulatory issues in the healthcare sector. The blog covers topics such as telehealth regulations, HIPAA compliance and enforcement actions, data privacy and security laws including the California Consumer Privacy Act (CCPA) and GDPR, healthcare provider obligations, and risk management strategies. It also addresses the impact of federal and state government actions on healthcare delivery, patient rights to access medical records, and the intersection of technology and health law. The content is aimed at healthcare providers, payors, and legal professionals navigating the evolving healthcare legal landscape.
Latest from Health Law | STAT - Page 2
Lessons Learned from ALJ Summary Judgment Against MD Anderson
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…
Artificial Intelligence in Health Care? The FDA is Ready, but Are We?
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…
CDRH’s Medical Device Safety Action Plan – An Aspirational Blueprint for Addressing Medical Device Safety
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…
CMS Overhauls Meaningful Use Program
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…
Medical Group Settles with New Jersey Attorney General for Health Data Privacy Breach Caused by Its Vendor’s Misconfigured FTP Site: Reminder of the Need to Conduct Vendor Due Diligence
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…
“Off-label” Cases Aren’t Going Away – DOJ Sheds Light on Direction of Enforcement of Misbranding Rules Governing Medical Products
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…
Digital Health Collaboration In The Medical Cannabis Space Announced Amid Legal Uncertainty
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…
HIPAA Small Breach Reporting Deadline Fast Approaching
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…
New Limits on Pharmaceutical Manufacturer Payments and Gifts to Prescribers in New Jersey
A new administrative rule issued by the New Jersey Attorney General took effect last month that places significant limitations on the payments and gifts that pharmaceutical manufacturers can provide to prescribers licensed in the Garden State. The rule, “Limitations on…