Archives: HIPAA/HITECH

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OCR Provides Guidance on the Privacy of Data Stored on Health Apps and Mobile Devices

In the wake of the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, many individuals and organizations have expressed uncertainty about the protection afforded to data stored on health apps, including cycle trackers.[1] As a result, the U.S. Department of Health & Human Services Office for Civil Rights (OCR) has issued guidance … Continue Reading

Office for Civil Rights Provides Guidance: HIPAA Privacy Rule on Disclosures of Information Relating to Reproductive Healthcare

On June 29, in response to the U.S. Supreme Court’s decision in Dobbs v. Jackson Women’s Health Organization, the U.S. Department of Health & Human Services Office for Civil Rights (HHS OCR) issued guidance on when entities covered by the Health Insurance Portability and Accountability Act (HIPAA) are permitted to share protected health information (PHI) … Continue Reading

Dobbs Triggers Significant Healthcare and Privacy Law Concerns and Confusion

To help guide entities through the significant confusion and changes that will be evolving for the next several years, BakerHostetler has assembled the Dobbs Decision Task Force (DDTF), led by attorneys in five major areas (healthcare/health tech, privacy, labor and employment, employee benefits, and white collar). Like many others, healthcare entities are facing immediate uncertainty … Continue Reading

Why Everyone Is Talking About a Rarely Invoked Rule – the FTC’s Health Breach Notification Rule

Back in September, the Federal Trade Commission (FTC) issued (by a 3-2 vote) a policy statement (the Statement) regarding the oft-forgotten Health Breach Notification Rule (the Rule). I was at the FTC when the Statement was released and have since joined BakerHostetler. Around the time I joined BakerHostetler, my new colleague Melissa Hewitt published an … Continue Reading

New Director of HHS Office for Civil Rights Announced: What could Lisa J. Pino’s appointment mean for future HIPAA enforcement?

More than eight months into the Biden administration, the U.S. Department of Health & Human Services (HHS) announced the appointment of Lisa J. Pino as the new director of the Office for Civil Rights (OCR) on Sept. 27, 2021. As the new director of the OCR, Pino will be responsible for enforcing the Health Insurance … Continue Reading

Effective Oct. 1, 2021: Connecticut Expands Data Breach Notification Statute

On June 16, 2021, the Connecticut General Assembly adopted an expanded version of Connecticut’s data breach notification statute (2021 CT H.B. 5310 (NS)). Through this expansion, Connecticut’s data breach notification statute will be updated, effective Oct. 1, 2021, to (1) broaden the definition of “personal information,” (2) shorten the amount of time within which businesses … Continue Reading

FTC Issues Statement Warning Health Apps to Notify Consumers About Data Breaches

The U.S. Federal Trade Commission (FTC) issued a policy statement on Sept. 15, 2021, warning that the decade-old Health Breach Notification Rule (the rule) – which applies to companies that handle personal health records or collect health data –  to notify consumers, the FTC and, in some cases, the media about data breaches. “In practical … Continue Reading

Court Finds HHS Had No Lawful Basis Under HIPAA for a $4.3 Million Civil Money Penalty: What Does This Mean for Future HHS Enforcement Actions?

The United States Court of Appeals for the Fifth Circuit recently found that the United States Department of Health and Human Services (HHS) lacked a lawful basis for a $4.3 million civil money penalty order that it issued to a healthcare provider for alleged violations of the Health Insurance Portability and Accountability Act of 1996 … Continue Reading

Compliance and Cybersecurity Best Practices Rewarded with HIPAA Safe Harbor

On January 5, 2021, H.R. 7898 was signed into law with little fanfare, thereby amending the Health Information Technology for Economic and Clinical Health Act.[1] As the healthcare industry continues to serve as one of the top targets for cybersecurity threat actors, the amendment creates a “HIPAA safe harbor” that should hopefully provide some much-needed relief to those … Continue Reading

CARES Act Significantly Revises Part 2 Rules to Better Align with HIPAA

On March 27, 2020, President Trump signed the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) into law. While the focus of the CARES Act has been on direct financial aid to Americans, the Act also contains a number of material revisions to the Federal privacy provisions that govern the confidentiality of substance-use … Continue Reading

Federal Court Invalidates 2013 HIPAA Omnibus Rule Regulations and HHS Guidance on Fees for Copies of Medical Records

In what is being seen as a strong rebuke to years of regulatory overreach, the United States District Court for the District of Columbia entered an order on January 23, 2020 that invalidates provisions of the 2013 Omnibus Rule to the Health Insurance Portability and Accountability Act (“HIPAA”) and 2016 guidance issued by United States … Continue Reading

Departments of Education and HHS Release Joint Guidance on the Relationship Between FERPA and HIPAA

At the end of 2019, the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR) and U.S. Department of Education Student Privacy Policy Office (ED) issued an update to their joint guidance on the relationship between the Family Educational Rights and Privacy Act (FERPA) and the Health Insurance Portability and Accountability … Continue Reading

Everything Data!

Thank you to our clients and relationships, as well as to the BakerHostetler team who made the creation of the new Digital Assets and Data Management (DADM) Practice Group possible. In a world dependent on data, this group takes a 360-degree approach to the delivery of services and counsel to clients on how they manage … Continue Reading

‘Apparent Inconsistency’ in HITECH Language Leads HHS OCR to Significantly Decrease Yearly Fines

On April 26, 2019, the U.S. Department of Health & Human Services (HHS) issued an announcement that the annual penalty cap for three of the four tiers of HIPAA violations would be reduced significantly to match what HHS called a “better reading” of inconsistent language found in the Health Information Technology for Economic and Clinical … Continue Reading

Deeper Dive: The Landscape of Healthcare Data Breaches

Healthcare was the industry most affected by data breaches in 2018. We worked on nearly 200 healthcare matters involving multispecialty academic medical centers, hospital systems, small and large physician practices, small and large health insurers, and biotech and pharmaceutical companies. In 2018, health information alone was just behind Social Security numbers (which can also be … Continue Reading

Deter Workforce Snooping in Electronic Medical Records Through Education and Training

On March 6, 2019, the U.S. Department of Justice (DOJ) announced that Linda Sue Kalina pled guilty to wrongfully disclosing the protected health information (PHI) of another individual in violation of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Kalina was a patient information coordinator with the University of Pittsburgh Medical Center (UPMC) … Continue Reading

Trojan Malware Reclaims the Top Spot as the Greatest Cyber Threat to the Healthcare Sector

Cybersecurity threats continued to plague the healthcare sector in 2018. Healthcare organizations notified twice as many individuals under HIPAA and other notification statutes in 2018 as compared with 2017. According to a new report from Malwarebytes Labs, 2019 State of Malware Report, trojan malware was the greatest threat to the healthcare sector in 2018.[1] Specifically, … Continue Reading

Best Cybersecurity Practices for Healthcare Organizations – Insider-Caused Data Loss

This article is part of a series of blog posts exploring the recommendations and guidance Health & Human Services (HHS) provides to healthcare organizations in its Cybersecurity Best Practices report. For previous articles in the series, click here. While any security incident may cause an entity heartburn, when the incident is traced back to an … Continue Reading

Clearly Defined HIPAA and FERPA Policies May Help Covered Entities in Defending a Claim for Unemployment Compensation

Recently, in Dantry v. Unemployment Compensation Board of Review, No. 1665 C.D. 2017 (Pa. Cmwlth. 2019), the Commonwealth Court of Pennsylvania reversed the order of the Unemployment Compensation Board of Review (Board) which  had affirmed the Unemployment Compensation Referee’s decision that Jami M. Dantry (Dantry) was ineligible for unemployment compensation benefits because Dantry’ s conduct … Continue Reading

Best Cybersecurity Practices for Healthcare Organizations – Loss or Theft of Devices

This article is part of a series of blog posts exploring the recommendations and guidance Health & Human Services (HHS) provides to healthcare organizations in its Cybersecurity Best Practices report. For previous articles in the series, click here. The report on cybersecurity best practices (Report) weighs in on one of the issues many entities find … Continue Reading

Best Cybersecurity Practices for Healthcare Organizations – Ransomware Prevention

This article is part of a series of blog posts exploring the recommendations and guidance Health & Human Services (HHS) provides to healthcare organizations in its “Cybersecurity Best Practices” report. For previous articles in the series, click here. The report on cybersecurity best practices (Report) is not the first time HHS has discussed the prevalent … Continue Reading

What Can We Learn From the Healthcare Data Breach ‘Wall of Shame’?

In addition to dealing with the public outcry and regulatory scrutiny resulting from a healthcare data breach, covered entities under the Health Insurance Portability and Accountability Act (or their business associates) are required to report breaches to the Department of Health & Human Services’ (HHS) Office for Civil Rights. But the pain doesn’t end there. … Continue Reading

The Use of Smart Speakers in Healthcare

Smart speakers are voice-activated, internet-connected devices with an integrated virtual assistant that can answer questions, follow instructions and control other smart devices. Nearly one in five U.S. adults has access to a smart speaker, and it has been estimated that in 2018, the number of smart speakers installed reached 100 million worldwide. Using voice recognition, … Continue Reading

Best Cybersecurity Practices for Healthcare Organizations – Phishing Prevention

This article is part of a series of blog posts exploring the recommendations and guidance Health and Human Services (HHS) provides healthcare organizations in its Cybersecurity Best Practices report. For previous articles in the series, click here. In its report on cybersecurity best practices, HHS highlights email phishing attacks as one of the top threats … Continue Reading
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