News & Analysis as of September 17, 2024

Protected Health Information

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Business Associates can refer broadly to individuals engaged in business relationships with one another. However, in the HIPAA context, the term has a specific statutory meaning and those characterized as business associates have expanded data protection obligations and duties. Essentially, a business associate under HIPAA is a person or entity that performs certain functions or services which necessitates exposure to protected health information on behalf of a covered entity. Typical business associate functions include: claims processing or administration, data analysis, billing, etc. less -

What HIPAA Security Rule Surprises Await Healthcare Providers for the Second Half of 2024?

Holland & Knight LLP on 5/14/2024

The U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) has, as part of its mandate, the responsibility to enforce the Health Insurance Portability and Accountability Act (HIPAA) Security Rule....more

Annual Report to Congress on HIPAA Privacy, Security, and Breach Notification Rule Compliance

Benesch on 4/4/2024

The U.S. Department of Health and Human Services (HHS), Office for Civil Rights (OCR) recently published an executive summary (Report) outlining key enforcement activities of the Health Insurance Portability and...more

HHS OCR Provides Annual Report to Congress Detailing 2022 Enforcement Activities

BakerHostetler on 3/19/2024

On Feb. 16, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) published its 2022 Annual Report to Congress. ...more

The Long-Awaited Part 2 Modifications Are Finalized with New Obligations for Part 2 Providers and Less Friction for Sharing...

BakerHostetler on 3/1/2024

On February 8, 2024, the U.S. Department of Health & Human Services (HHS) released a final rule modifying 42 CFR Part 2 (Part 2) provisions regarding the confidentiality of Substance Use Disorder (SUD) Patient Records. The...more

The Potential Impact of State Abortion Laws on Reproductive Health Apps

Goodwin on 7/19/2022

Millions of women use reproductive health applications (or “apps”) to track menstrual cycles, ovulation, and pregnancy. These apps provide women that use the rhythm method for birth control and women seeking to become...more

OCR: Current Fines Too Low to Spur Compliance; Agency Also Seeks Funding Boost, Injunctive Relief

Health Care Compliance Association (HCCA) on 5/6/2022

Report on Patient Privacy 22, no. 5 (May, 2022) - Compared to other agencies, the HHS Office for Civil Rights (OCR) is a little fish in the big federal pond, but it has an outsize effect on HIPAA covered entities (CEs) and...more

Important FTC Rules for Health Apps Outside of HIPAA

Holland & Knight LLP on 9/27/2021

The Federal Trade Commission (FTC) adopted a policy statement on Sept. 15, 2021, emphasizing that developers of digital health apps, connected devices and other health products have obligations under the Health Breach...more

Modified HIPAA Rules for Sending Records to Third Parties

Holland & Hart - Health Law Blog on 2/10/2020

Thanks to a federal judge, the Office for Civil Rights has modified its rules for sending records to third parties. Covered entities are no longer required by HIPAA to send non-electronic protected health information (“PHI”)...more

Some Reminders on How HIPAA Works

WilmerHale on 11/22/2019

The HIPAA privacy rules have been in the news a lot lately. That’s good, but not when it’s for the wrong reasons or based on a misunderstanding of the rules....more

Understanding When Business Associates Are Directly Liable Under HIPAA

Miller Canfield on 6/4/2019

New guidance issued by the U.S. Department of Health & Human Services (HHS) Office for Civil Rights (OCR) reaffirms that business associates must have proper HIPAA compliance practices, safeguards and documentation in place...more

Liability of Business Associates for HIPAA Penalties

Holland & Hart - Health Law Blog on 5/30/2019

The HITECH Act extended certain HIPAA obligations to business associates, including those entities that create, receive, maintain or transmit protected health information (“PHI”) on behalf of covered entities. Business...more

Good News for Covered Entities and Business Associates: Recent HHS HIPAA Pronouncements Acknowledge Realities and Soften Impact

Arnall Golden Gregory LLP on 5/8/2019

In two recent pronouncements, the United States Department of Health and Human Services (HHS) has taken a balanced approach to interpreting the Health Insurance Portability and Accountability Act (HIPAA) regulations that...more

HHS Decreases Maximum HIPAA Penalties

Ballard Spahr LLP on 5/6/2019

The Department of Health and Human Services has announced that it is lowering the maximum amount it will assess for most types of HIPAA violations. Although the change is couched as an exercise of discretion, HHS states that...more

One Month Left to Submit Comments on HIPAA Request For Information

Verrill on 1/11/2019

Last month, the Office for Civil Rights (“OCR”) within the U.S. Department of Health and Human Services (“HHS”) published a Request for Information (“RFI”) looking for recommendations and public input regarding the Health...more

Healthcare Business Associates

BCLP on 11/6/2018

The Health Information Technology for Economic and Clinical Health (“HITECH”) Act modified the Health Insurance Portability and Accountability Act (“HIPAA”) by expanding the definition of Business Associates (“BA”) and their...more

Cost-Benefit Analysis 101 For Healthcare Providers

Jackson Lewis P.C. on 3/15/2018

Nary a week goes by without news of a data breach by a healthcare provider…while there are certainly a good number of breaches resulting from a breach of cybersecurity defenses or from the wrongful exploitation of system...more

HIPAA Check: Do You Know What to Do if a Breach Happens to You?

Williams Mullen on 11/8/2017

Breaches happen. They happen to major health systems, and they happen to solo practitioners. They happen to health plans, and they happen to health information technology vendors. In our technology-reliant world, it would be...more

Healthcare Business Associates

BCLP on 6/28/2017

Securing Protected Health Information: FBI Warning

Burns & Levinson LLP on 4/14/2017

HIPAA and the HITECH are federal laws that require the protection and security of confidential, protected health information (PHI) and personally identifiable information that is not necessarily health related. The federal...more

OCR Identifies Continuing HIPAA Enforcement Issues, Areas of Future Guidance and Regulations

Mintz - Health Care Viewpoints on 4/4/2017

Last week the Health Care Compliance Association hosted its annual “Compliance Institute.” Iliana Peters, HHS Office for Civil Rights’ Senior Advisor for HIPAA Compliance and Enforcement, provided a thorough update of HIPAA...more

OCR Begins HIPAA Phase 2 Audits

Morgan Lewis on 7/19/2016

What covered entities and business associates can do to prepare for the next round of audits. On July 11, the HIPAA Phase 2 audits commenced when 167 covered entities received notice of a desk audit from the Department...more

HIPAA Audit Program Update—HHS OCR Moves Forward with Desk Audits

Akin Gump Strauss Hauer & Feld LLP on 7/15/2016

As we previously reported, on March 21, 2016, the U.S. Department of Health and Human Services Office for Civil Rights (OCR) launched the long-awaited Phase 2 of the audit program that is intended to assess compliance with...more

Just a Matter of Time: First-Ever Settlement of HIPAA Claims Against a Business Associate

McGuireWoods LLP on 7/13/2016

On June 30, 2016, the Health and Human Services Office for Civil Rights (OCR) announced the first-ever settlement of Health Insurance Portability and Accountability Act (HIPAA) claims against a business associate. According...more

OCR levies first fine ever directly against business associate

Robinson+Cole Data Privacy + Security Insider on 7/6/2016

Our predictions that the Office for Civil Rights (OCR) will become more aggressive with audits, investigations, and fines against HIPAA business associates has come true. On June 24, 2016, the OCR announced that it has...more

Health Law Wire: Recent HIPAA Settlements Highlight the Importance of Business Associate Agreements (5/16)

Bond Schoeneck & King PLLC on 5/19/2016

The Office of Civil Rights (OCR), the agency within the United States Department of Health and Human Services that enforces the HIPAA Privacy and Security Rules, recently sent a clear message about the importance of business...more

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