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Keeping you afloat amidst the rising sea of regulations

Health Fraud Rule Withdrawal May Hurt Enforcement Efforts

Partner Linda Baumann was recently quoted in the Bloomberg BNA article, “Health Fraud Rule Withdrawal May Hurt Enforcement Efforts,” appearing in both the Health Care Daily Report and the Medicare Report. The article discusses how fraud enforcement efforts in the health care industry may be hindered by the Trump Administration’s delay of a program integrity final rule that would have strengthened the government’s ability to suspend or revoke provider enrollment in Medicare and Medicaid.

Trump Administration Orders Regulatory Freeze and the Elimination of Two Pre-existing Regulations for Every New Regulation Issued

On January 20, 2017, President Trump’s Chief of Staff, Reince Priebus, issued a memorandum implementing an immediate regulatory freeze of any new or pending regulations until they have been reviewed and approved by Trump Administration appointees.

Health Care Compliance Association (HCCA) Webinar: Navigating the Rest of the Iceberg - Privacy and Security Compliance Beyond HIPAA

Please join Arent Fox partners Sarah Bruno and Matthew Mills on Tuesday, February 21 from 1:00-2:30 PM Eastern for a Health Care Compliance Association webinar titled Navigating the Rest of the Iceberg: Privacy and Security Compliance Beyond HIPAA. 

FDA Finalizes Guidance on Assessing New Drug Abuse Potential

Earlier this month, FDA finalized Guidance for Industry, Assessment of Abuse Potential of Drugs. This guidance is intended to assist researchers and sponsors of new drugs that may have central nervous system (CNS) activity evaluate whether the drug has abuse potential.

The Secret's Out: FDA Allows Drug and Device Manufacturers to Share HCEI Prior to Product Approval

Last week, FDA issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers, describing the Agency’s expectations for drug and device manufacturers’ communication of health care economic information (HCEI) about their products t

How Millennials Will Change Health Care IT

* The following article was originally published by Healthcare Business & Technology. To read it on the Healthcare Business & Technology website, click here. 

CMS Rule Prohibiting Binding Arbitration Put on Hold

* The following article was originally published by California Healthcare News. To read it on the California Healthcare News website, click here. 

Life’s a Breach - Sitting on that HIPAA Breach Notification Could Burn You

What’s the News? On January 9, 2017, Presence Health agreed to settle with the U.S. Department of Health and Human Services (HHS) potential violations under the Breach Notification Rule of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). This is HHS’ first enforcement action against a covered entity that reported a breach, but did not do so timely.

FTC Arms Businesses and Consumers Against Ransomware

Ransomware is a living-nightmare for the health care industry, with attacks or threats of attacks increasing and the consequences potentially devastating to patients and businesses. The Federal Trade Commission recently issued guidance for both businesses and consumers on defending against ransomware, which Arent Fox attorneys Sarah Bruno, Eva Pulliam, and Lourdes Turrecha analyze in the article below. What’s the News?