News & Analysis as of

Patient Privacy Rights Dept. of Health and Human Services

(Un)Protected Health Information Held for Ransom

by Snell & Wilmer on

Recent experiences of major health care companies offer a reminder of the importance of data security and following a well-written policy for compliance with the HIPAA Privacy Rule....more

Global Privacy & Cybersecurity Update Vol. 14

by Jones Day on

New York Attorney General Announces Record Number of Data Breach Notices in 2016 - On March 21, 2017, the New York Attorney General's Office announced that it received 1,300 reported data breaches in 2016—a 60 percent...more

HHS Plans To Launch Cybersecurity Center Focused On Medical App Security

by Dentons on

The US Department of Health and Human Services (HHS) announced on April 20 that it plans to launch a cybersecurity initiative modeled on the US Department of Homeland Security’s National Cybersecurity and Communications...more

HHS to Launch Cybersecurity Center

The Department of Health and Human Services (HHS) will soon launch a healthcare focused cybersecurity initiative modeled on the Homeland Security Department’s National Cybersecurity and Communications Integration Center...more

Recent HIPAA Privacy and Security Settlements and Lessons Learned

by Perkins Coie on

Although the fate of the Affordable Care Act remains undecided, enforcement of the HIPAA privacy and security regulations by the Office for Civil Rights (OCR) of the U.S. Department of Health and Human Services is ongoing,...more

Confidentiality of Alcohol and Drug Abuse Patient Records - Final Rule Revising Regulations

by Ruder Ware on

The Department of Health and Human Services (HHS) has released a final rule to update and modernize the Confidentiality of Alcohol and Drug Abuse Patient Records regulations effective February 17, 2017. ...more

New HHS Secretary Delays Effective Date of Part 2 Final Rule

We previously reported that the 30 year old regulations (last updated in 1987) relating to the disclosure of substance abuse treatment information has been updated by SAMHSA to bring it into the modern world of electronic...more

Six Key Changes to the Common Rule

by Epstein Becker & Green on

On January 19, 2017, sixteen federal agencies, including the Departments of Health and Human Services and Labor, published the first revision to the federal regulations governing the protection of human subjects participating...more

HHS Modifies Drug and Alcohol Abuse Confidentiality Regulations, Proposes Additional Revisions

by Bass, Berry & Sims PLC on

On January 18, 2017, the U.S. Department of Health and Human Services, Substance Abuse and Mental Health Services Administration (SAMHSA) released a final rule (the Final Rule) modifying the federal regulations governing the...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

Five Key Issues Impacting Health Care Employers

by Epstein Becker & Green on

Employers in the health care industry are likely to face significant changes under President-elect Donald J. Trump’s administration and should expect a healthy dose of uncertainty for the next few months. During his campaign,...more

Health Update - August 2016

Section 1332 Waivers: Will We See More State Innovation? - Editor's Note: In a new essay for the National Institute of Health Care Management (NIHCM), summarized below, Manatt Health examines Section 1332 waivers and the...more

Health Update - July 2016

The Vulnerability of Healthcare Information - According to a report the Brookings Institute issued in May 2016, 23% of all data breaches occur in the healthcare industry. Nearly 90% of healthcare organizations had some...more

Two Additional HIPAA Settlements Demonstrate Breadth of HIPAA Enforcement Activity

During the week of April 18, 2016, the U.S. Department of Health and Human Services, Office for Civil Rights (OCR) announced two significant settlements with a large New York City hospital and a North Carolina orthopaedic...more

Lights, Camera, Settlement: OCR says a picture is worth $2.2 million

A New York hospital has settled with the U.S. Department of Health and Human Services Office for Civil Rights (“OCR”) for $2.2 million after allowing a TV crew for the ABC documentary series “NY Med” to film patients...more

Provider Confusion and Interoperability Concerns Prompt OCR and ONC to Release Guidance on PHI Sharing

Last Friday, the U.S. Department of Health and Human Services Office of the National Coordinator for Health IT (“ONC”) and the Office for Civil Rights (“OCR”) released two fact sheets regarding permitted uses and disclosures...more

HHS’ Selection of Contractor Provides Latest Update on Impending Second Round of HIPAA Audits

by Reed Smith on

On October 27, 2015, a U.S. Department of Health and Human Services (“HHS”) official stated that the agency has hired FCi Federal, a provider of management and professional services to government agencies in Ashburn, VA, to...more

OIG Reports Insufficient Oversight Of HIPAA Compliance

by King & Spalding on

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

HHS Issues Proposed Rule That Would Revise the Federal Policy for the Protection of Human Subjects

by King & Spalding on

Proposals are Intended to Enhance Protections for Higher Risk Clinical Research and Privacy Safeguards, including Uses of Biospecimens and Identifiable Private Information - On September 8, 2015, the Department of Health...more

Six Ways for Data-Driven Medical Device Companies to Implement Effective Privacy and Security Measures

by Arnall Golden Gregory LLP on

The increasing amounts of health information being generated, stored and collected have heightened the special risks medical device manufacturers have long faced. In addition to the nexus to patient health and safety, if a...more

What Can You Expect in 2015 Regarding HIPAA Enforcement?

As of earlier this month, 1, 170 breaches involving 31 million records have been reported to the Department of Health and Human Services (HHS) since mandated reporting of breaches began in September 2009.  An increase in the...more

OIG’s New Work Plan Focuses on the Security of Health Information

by Cozen O'Connor on

On October 31, 2014, The U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) released its Work Plan for fiscal year (FY) 2015. The Work Plan summarizes “new and ongoing reviews of activities...more

HIPAA Privacy in Emergency Situations

by Davis Brown Law Firm on

In light of the Ebola outbreak and other events, the U.S. Department of Health and Human Services, Office for Civil Rights, released a bulletin to ensure HIPAA covered entities are aware of the ways in which patient...more

Confidentiality of Substance Abuse Treatment Information: HHS Considers Changes to the Part 2 Regulations and Requests Comment

by Davis Wright Tremaine LLP on

The Department of Health and Human Services’ Substance Abuse and Mental Health Services Administration (SAMHSA) is considering significant changes to the “Part 2” regulations (the Confidentiality of Alcohol and Drug Abuse...more

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