News & Analysis as of

42 C.F.R. Part 2 Final Rule Is Officially Delayed … Can Comments to HHS and OMB Fix It?

On January 18, 2017, the U.S. Department of Health and Human Services (HHS) published a final rule amending the Confidentiality of Substance Use Disorder Patient Records rule at 42 C.F.R. Part 2. Yesterday, HHS delayed the...more

The 21st Century Cures Act

Signed into law by President Obama on December 13, 2016, the 21st Century Cures Act (Act) was overwhelmingly supported in both houses of Congress and comprises a dizzying array of provisions aimed to improve and modernize...more

21st Century Cures Act - HIPAA & Other Privacy Considerations

On December 13, 2016, President Obama signed the 21st Century Cures Act (the Cures Act) into law. The Cures Act addresses a wide range of healthcare topics including clinical research, treatment of mental health and substance...more

21st Century Cures Act – Provisions Relating to Digital Health

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (the Act), just days after it passed in the U.S. House of Representatives and Senate. With an overarching goal of advancing biomedical...more

Medicare, Medicaid Payment Policies, Fraud Authorities Enacted as Part of 21st Century Cures Act

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Cures Act). While much of the focus has been on policies intended to accelerate drug and device development and approval, the Cures Act also...more

The 21st Century Cures Act: FDA Reforms Aim to Spur Innovation in the Pharmaceutical, Medical Device and Health Research Sectors

On December 13, 2016, President Obama signed into law the 21st Century Cures Act (Act), one of the most important pieces of health care and life sciences legislation in several decades. The Act is intended to spur the rapid...more

Trump’s Impact on Digital Health: An Analytic Framework for Evaluating the Changing Landscape

The promise of health care reform by the incoming administration will result in significant changes; but understanding how those changes may flow through to digital health industry requires an analytic framework that...more

21st Century Cures: Health Information Technology and Digital Health Tool Provisions in Title IV

The 21st Century Cures Act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide variety of other health-related measures, including...more

The U.S. Department of Health and Human Services Publishes Two Free Resources to Help Practices Navigate Healthcare IT

The U.S. Department of Health and Human Services (“HHS”), Office of the National Coordinator (“ONC”) has published two free online playbooks to assist healthcare providers navigate healthcare information technology (“IT”)....more

ONC Revises Health IT Certification Program Requirements

The HHS Office of the National Coordinator for Health Information Technology (ONC) has adopted a final rule to enable the ONC to directly review certified health information technology (IT) to determine whether it conforms to...more

OCR Explains How Information Blocking Violates HIPAA

The US Department of Health and Human Services Office for Civil Rights recently posted guidance clarifying that a business associate such as an information technology vendor generally may not block or terminate access by a...more

OIG laments failure to comprehensively address EHR fraud

The U.S. Department of Health & Human Services (HHS) Office of Inspector General (OIG) recently released a compendium (Compendium) of its top unimplemented recommendations. The Compendium comprises 25 unimplemented past OIG...more

Health Law Insights Newsletter - Issue 7 - March 2016

McCarter & English, LLP’s Health Care Group presents Issue 7 of the Health Law Insights, which discusses the latest legal issues in the health care industry. NATIONAL - Providers’ Obligation to Report Medicare...more

HHS Seeks Nominees for New Health Care Cybersecurity Task Force; Nominations Due March 9

HHS is forming a new “Health Care Industry Cybersecurity Task Force” as part of the Administration’s effort to improve preparedness for cybersecurity threats affecting the health care industry. HHS is accepting nominations...more

A&B Healthcare Week in Review

I. REGULATIONS, NOTICES, & GUIDANCE - On February 24, 2016, the Centers for Medicare & Medicaid Services (CMS) issued a guidance entitled, “Special Enrollment Confirmation Process” that will enhance program integrity...more

SAMHSA Proposes Updates to Substance Abuse Records Security and Confidentiality Regulations

The U.S. Department of Health and Human Services’ (HHS) Substance Abuse and Mental Health Services Administration (SAMHSA) has released proposed changes to the Confidentiality of Alcohol and Drug Abuse Patient Records...more

ONC Corrects EHR Certification Criteria Final Rule

The HHS Office of the National Coordinator for Health Information Technology (ONC) has published a notice correcting errors and clarifying provisions of its October 16, 2015 rule that finalized the 2015 edition health...more

CMS Adopts Changes to Medicare & Medicaid EHR Policies

The Centers for Medicare & Medicaid Services (CMS) has published a sweeping final rule with comment period that specifies the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals...more

ONC Issues Final Health IT Interoperability Roadmap

The HHS Office of the National Coordinator for Health Information Technology (ONC) has released its final “Roadmap” to promote the secure exchange and use of electronic health information. The document, “Connecting Health and...more

HHS OIG “Reminder” about Information Blocking & the Federal Anti-Kickback Statute

The HHS Office of Inspector General (OIG) recently released a “Policy Reminder” on how “information blocking” — defined by HHS as knowingly and unreasonably interfering with the exchange or use of electronic health...more

OCR Launches Platform for Developer HIPAA Questions

The HHS Office for Civil Rights (OCR) has released a new platform to provide mobile health developers (and any other interested stakeholders) a sounding board to ask questions, voice concerns, and “spitball” ideas about HIPAA...more

CMS and ONC Release Stage 3 Meaningful Use and EHR Certification Final Rules

On October 6, 2015, CMS released the final Stage 3 Meaningful Use Rule that, among other provisions, sets forth the requirements that eligible professionals (EPs), eligible hospitals, and critical access hospitals (CAHs) must...more

OIG Reports Insufficient Oversight Of HIPAA Compliance

The HHS Office for Civil Rights (OCR) must improve its oversight and enforcement of patient information privacy and security rules by “covered entities” and their business associates under the Health Information Portability...more

Is Your HIPAA Compliance Program Ready for the FTC?

Everyone in healthcare knows that the next round of HIPAA audits is coming. Covered entities and business associates have long been advised to review and update their HIPAA security risk analyses, have business associate...more

Also In The News - Health Headlines - October 2015 #2

HHS Publishes Final Federal Health IT Strategic Plan 2015-2020 – On September 21, 2015, the Office of the National Coordinator for Health Information Technology (ONC) of HHS laid out the federal government’s final version of...more

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