News & Analysis as of

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

Also In the News - Data, Privacy, & Security Practice Report - October 2015

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...more

CMS Issues Proposed Rule Significantly Modifying the Requirements for Long-Term Care Facilities Participating in the Medicare and...

On July 16, 2015, the Centers for Medicare & Medicaid Services (“CMS”) published a proposed rule comprehensively updating and extensively revising the requirements for participation for long term care (“LTC”) facilities...more

Time for a HIPAA Security Check-Up!

The 2015 HIPAA Security conference held by the National Institute of Standards and Technology (“NIST”) and the U.S. Department of Health and Human Services, Office for Civil Rights (“OCR”) kicked off last week with OCR’s...more

Cloud Sharing Apps Scrutinized for ePHI

In a relatively short time period, the direct costs of document storage have dropped precipitously, and cloud-based document storage has become ubiquitous. Clearly, this is a wave of the future. But a recent settlement...more

House Easily Passes 21st Century Cures Legislation, Includes Significant FDA Reforms

On July 10, 2015, the U.S. House of Representatives passed with an overwhelming majority (344-77), the 21st Century Cures bill (H.R. 6), a high-profile bipartisan bill intended to speed up and improve the process for...more

HIPAA Settlement Regarding Use of Internet Applications

On July 10, 2015, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced a settlement agreement with St. Elizabeth's Medical Center (SEMC) in Brighton, Massachusetts, regarding potential...more

Recent HHS Settlement Highlights Risks of Electronically-Sharing Protected Health Information

On July 10, 2015, the United States Department of Health and Human Services Office for Civil Rights (OCR) announced its second settlement of the year for violations of the Health Insurance Portability and Accountability Act...more

ONC Releases Privacy and Security Guidance Geared Toward Small Providers

The HHS Office of the National Coordinator for Health Information Technology (“ONC”) recently released a new and improved version 2.0 of their Guide to Privacy and Security of Electronic Health Information. This revamped...more

HHS Releases Two Healthcare Information Technology Proposed Rules

On March 20, 2015, CMS and the HHS Office of the National Coordinator for Health Information Technology (ONC) released proposed rules regarding Stage 3 of the Medicare and Medicaid Electronic Health Records (EHRs) Incentive...more

Finally…FDASIA Health IT Regulation Report Released

The U.S. Food and Drug Administration (FDA), along with HHS’ Office of the National Coordinator for Health Information Technology (ONC) and the Federal Communications Commission (FCC, together with FDA and ONC, the...more

Privacy and Security Alert: January 9th, 2014

On December 5, 2013, the Office of Inspector General (OIG) reported on the Office for Civil Rights’ (OCR) compliance as of May 2011 with oversight and enforcement of the Security Rule and compliance with federal cybersecurity...more

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