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False Claims Act Settlement with eClinicalWorks Raises Questions for Electronic Health Record Software Vendors

On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate...more

Final Rule Modernizes Substance Use Disorder Patient Record Confidentiality Regulations

On January 18, 2017, the Substance Abuse and Mental Health Services Administration (SAMHSA) released its long-awaited final rule amending the confidentiality regulations at 42 CFR Part 2 (Part 2) that apply to federally...more

21st Century Cures: A Closer Look

On December 7, 2016, the US Congress enacted the 21st Century Cures Act, substantial legislation intended to accelerate “discovery, development and delivery” of medical therapies by encouraging biomedical research investment,...more

21st Century Cures: Required Exploration of Telehealth Solutions

President Obama signed the 21st Century Cures Act on December 13, 2016. The act encourages biomedical research investment and facilitates innovation review and approval processes, but also serves as a vehicle for a wide...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

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

FDA Releases Draft Guidance on Postmarket Management of Cybersecurity in Medical Devices

On January 15, 2016, the U.S. Food and Drug Administration (FDA) published a draft guidance entitled Postmarket Management of Cybersecurity in Medical Devices (Draft Guidance), which outlines FDA’s recommendations for...more

Meaningful Use Stage 3 Final Rules Encourage Providers to Engage Patients in their Health Care

On October 16, 2015, the Centers for Medicare and Medicaid Services (CMS) and Office of the National Coordinator for Health Information Technology (ONC) of the U.S. Department of Health and Human Services published the...more

HHS Office of Inspector General Calls for Increased Oversight and Enforcement of HIPAA

On September 29, 2015, the U.S. Department of Health & Human Services Office of the Inspector General (OIG), Office of Evaluation and Inspections, released two studies calling on the HHS Office for Civil Rights (OCR) to...more

11/12/2015  /  Audits , Data Breach , HIPAA , HITECH , OCR , OIG

OCR Enforcement Trends

On April 27, 2015, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) announced a resolution agreement with Cornell Prescription Pharmacy (CPP) pursuant to which CPP paid a $125,000...more

OCR Launches Phase 2 HIPAA Audit Program with Pre-Audit Screening Surveys

Health Insurance Portability and Accountability Act of 1996 (HIPAA) covered entities have reported that the U.S. Department of Health and Human Services Office for Civil Rights (OCR) recently sent pre-audit screening surveys...more

OCR Transmits Pre-Audit Screening Surveys to Covered Entities for Phase 2 HIPAA Compliance Audits

The U.S. Department of Health and Human Services, Office for Civil Rights (OCR) recently transmitted HIPAA pre-audit screening surveys to covered entities that may be selected for a second phase of HIPAA compliance audits...more

FDA Issues Draft Guidance on General Wellness Devices and on Medical Device Accessories

On January 16, 2015, the U.S. Food and Drug Administration (FDA) posted a draft guidance document outlining the FDA’s proposed approach to the regulation of general wellness devices (Draft General Wellness Guidance) under the...more

Privacy and Data Protection: 2014 Year in Review

In 2014, regulators around the globe issued guidelines, legislation and penalties in an effort to enhance security and control within the ever-shifting field of privacy and data protection. The Federal Trade Commission...more

OCR to Begin Phase 2 of HIPAA Audit Program

The U.S. Department of Health and Human Services’ Office for Civil Rights (OCR) will soon begin a second phase of audits (Phase 2 Audits) of compliance with Health Insurance Portability and Accountability Act of 1996 (HIPAA)...more

The New Normal: Big Data Comes of Age

On May 1, 2014, the White House released two reports addressing the public policy implications of the proliferation of big data. The first report is by the Executive Office of the President, entitled “Big Data: Seizing...more

ACA Proposed Rule to Require Health Insurers to Certify Compliance with HIPAA Electronic Transaction Requirements

The U.S. Department of Health and Human Services issued a proposed rule to implement the ACA requirement that health insurers and other HIPAA-covered health plans certify compliance with the standards and operating rules for...more

HIPAA Omnibus Final Rule Compliance Date Is Only Two Months Away

The compliance date for the omnibus final rule amending the privacy, security, breach notification and enforcement regulations under the Health Insurance Portability and Accountability Act (HIPAA) and the Health Information...more

What Have We Learned from Audits under the Medicare EHR Incentive Program?

Through the first half of this year, the Centers for Medicare & Medicaid Services auditor has conducted numerous pre- and post-payment audits of meaningful use attestations submitted by eligible providers to the Medicare...more

HHS Extends Sunset Date for Stark Exception and Anti-Kickback Safe Harbor for EHR Donations

The Centers for Medicare & Medicaid Services and the U.S. Department of Health and Human Services issued proposed rules that would extend the sunset date for the Stark Law exception and the federal Anti-Kickback Statute safe...more

FTC Recommends Privacy Practices for Mobile Apps

A new Federal Trade Commission report urges mobile app platforms and developers to better inform consumers about their privacy practices. Mobile app platforms and developers should review their privacy policies to ensure...more

OCR Issues Final Modifications to the HIPAA Privacy, Security, Breach Notification and Enforcement Rules to Implement the HITECH...

On January 25, 2013, the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services (HHS) published a final rule (Final Rule) containing modifications to the privacy standards (Privacy Rule), security...more

HIPAA De-Identification Guidance

Office of Civil Rights has released additional guidance addressing the de-identification of protected health information in accordance with the HIPAA Privacy Rule. Covered entities should review their current...more

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