Tag Archives: HHS

HHS Extends Comment Period for Proposed Rules on Patient Access and Interoperability

On April 19, 2019, the Department of Health and Human Services (HHS) announced a 30-day extension, until June 3, 2019, to the comment period for two rules proposed by the Centers for Medicare & Medicaid Services (CMS) and the Office of the National Coordinator for Health Information Technology (ONC). The CMS proposed rule aims to … Continue Reading

HHS Clarifies HIPAA Liability for EHR System Developers that Transfer Data to Health Apps

On Friday, April 19, 2019, the Office for Civil Rights of the U.S. Department of Health and Human Services (HHS) explained in an FAQ the circumstances under which electronic health record (EHR) systems may be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) liability for an app’s impermissible use or disclosure … Continue Reading

HHS Releases Voluntary Cybersecurity Guidance

Hospitals and other health care organizations are attractive targets for cyber-attacks, in part because their databases contain medical records and other sensitive information. Breaches of this information could have very serious implications for patients.  Moreover, electronics connected to a health care facility’s network keep people alive, distribute medicines, and monitor vital signs. As a result, … Continue Reading

HHS Announces More HIPAA Enforcement Actions

The beginning of 2017 has brought a number of HIPAA enforcement actions involving covered entities. These enforcement actions indicate that HHS is continuing recent efforts to step up HIPAA enforcement and levy significant penalties for non-compliance. In January, HHS announced that it had reached a $475,000 settlement with a large health care network for failure … Continue Reading

Significant HIPAA Fine Follows Business Associate’s Stolen iPhone

A new post over on Covington’s eHealth blog discusses a recent enforcement action taken by the Office for Civil Rights (OCR) at the U.S. Department of Health and Human Services (HHS) against Catholic Health Care Services, a business associate under HIPAA, arising out of a stolen iPhone.  This recent enforcement action should put business associates … Continue Reading

FTC Releases Online Tool to Help Health App Developers Identify Applicable Laws

A new post on the Covington eHealth blog discusses the new web-based interactive tool released by the FTC, in conjunction with HHS and the FDA, to assist mobile health app developers in navigating applicable federal laws and regulations in the areas of advertising and marketing, medical devices, and data security and privacy.  As part of … Continue Reading

HHS Updates Health Data Privacy and Security Guide

The  Office of the National Coordinator for Health Information (ONC) recently released an updated Guide to Privacy and Security of Electronic Health Information.  The guide aims to help individuals, providers, and the health IT community understand the role of HIPAA for interoperability of health information. This guide updates the previous version issued by the ONC … Continue Reading

Two HIPAA Settlements Follow Stolen Laptops

Recently, HHS Office of Civil Rights (OCR) announced that it has entered into settlement agreements with two entities following enforcement actions, both arising from stolen laptops that were not encrypted in accordance with the Security Rule.  According to HHS, an unencrypted laptop was stolen from a physical therapy center in Springfield, Missouri.  The center was … Continue Reading

HHS Issues Proposed Rule on HIPAA and Firearm Background Check Reporting

By Anna Kraus On January 7, 2014, the Department of Health and Human Services (HHS) published a notice of proposed rulemaking to modify the HIPAA Privacy Rule to expressly allow certain disclosures to the National Instant Criminal Background Check System (NICS).  As we previously reported, this was one of the executive actions in President Obama’s plan … Continue Reading

HHS Announces First HIPAA Settlement Based on Lack of Breach Notification Policies and Procedures

By Anna Kraus On December 27, 2013, the Office for Civil Rights (OCR) within the Department of Health and Human Services (HHS) announced a HIPAA settlement with Adult & Pediatric Dermatology, P.C. (APDerm), a private dermatology practice with locations in Massachusetts and New Hampshire.  According to HHS, this is the first settlement based on a … Continue Reading

HHS OIG Releases Report on HIPAA Enforcement Efforts

Recently, the Office of Inspector General (OIG) at HHS released a report on the HIPAA enforcement efforts of HHS’s Office for Civil Rights (OCR).  Specifically, the OIG looked at whether OCR’s efforts to enforce HIPAA’s Security Rule were adequate.  The OIG’s findings may lead to increased enforcement efforts by OCR.  Background on the Security Rule … Continue Reading

HHS Issues Guidance on Refill Reminders under HIPAA

On September 19, HHS released additional guidance on the “refill reminder exception” in HIPAA, which allows — in some circumstances — paid communications regarding a drug or biologic currently prescribed to a patient. Background In January 2013, HHS finalized new restrictions on marketing as part of the final omnibus rule implementing changes to HIPAA under … Continue Reading

HHS Announces $1.7 Million HIPAA Settlement With WellPoint

On July 11, the Department of Health and Human Services (HHS) announced that WellPoint, a managed care company, paid HHS $1.7 million to settle potential violations of the HIPAA Privacy and Security Rules.  Like other recent enforcement actions, HHS initiated its investigation into WellPoint after the company provided notification of a breach of unsecured protected … Continue Reading

HHS Releases Unofficial Set of Combined HIPAA Regulations

On June 11, the Department of Health and Human Services released an unofficial version of all of the HIPAA regulatory standards in one document.  The combined regulation text includes the following HIPAA standards: Transactions and Code Set Standards Identifier Standards Privacy Rule Security Rule Enforcement Rule Breach Notification Rule The document reflects the changes in … Continue Reading

HHS Settles HIPAA Privacy Case With California Medical Center

By Anna Kraus The Department of Health and Human Services (HHS) announced on June 14 that it reached a settlement with Shasta Regional Medical Center (SRMC) in California over potential violations of the HIPAA Privacy Rule.  Under the settlement, SRMC agreed to pay $275,000 and implement a comprehensive corrective action plan (CAP). HHS’s investigation was … Continue Reading

HITECH Update #10: HHS Releases First Sample Business Associate Agreement Provisions Since HITECH Act, Omnibus Rule

This post is part of our series on key aspects of the final HITECH omnibus rule published by the U.S. Department of Health and Human Services (HHS) in the Federal Register on January 25, 2013. Previous posts are available here. The regulations are effective March 26, 2013, but covered entities and business associates have until … Continue Reading

HITECH Update #9: Omnibus Rule Revises Individual Rights to Request Restrictions, Access to Protected Health Information

This post is part of our series on key aspects of the final HITECH omnibus rule published by the U.S. Department of Health and Human Services (HHS) in the Federal Register on January 25, 2013. Previous posts are available here. The regulations are effective March 26, 2013, but covered entities and business associates have until … Continue Reading

HITECH Update # 7: New HIPAA Requirements for Business Associates and Their Subcontractors

This post is part of our series on key aspects of the final HITECH omnibus rule published by the U.S. Department of Health and Human Services (HHS) in the Federal Register on January 25, 2013. Previous posts are available here. The regulations are effective March 26, 2013, but covered entities and business associates have until … Continue Reading
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