OCR Sees Uptick in Ransomware Incidents
During the Fall 2024, the HHS OCR concluded 3 investigations resulting in settlement payments relating to ransomware incidents. In all three instances, OCR found that the entities that encountered the cybersecurity incidents had not conducted a compliant risk analysis and did not sufficiently monitor their health information systems’ activity. there has been a 264% uptick in large ransomware breaches since 2018.
Texas Sues to Block new HIPAA Reproductive Health Care Rule
Texas Attorney General, Ken Paxton, has sued HHS alleging that the HIPAA Reproductive Health Care Privacy Rule amendments infringe on the state’s investigative authority and that the HIPAA statute does not grant sufficient authority to HHS to promulgate such a rule. Texas is seeking an injunction against enforcement of the final rule.
Lessons Learned from Real Time vs. PointClickCare: Mind your Information Blocking Ps and Qs
A federal district judge has granted preliminary injunctive relief to Real Time Medical Systems, Inc. (“Real Time”) barring the defendant, PointClickCare (“PCC”), from deploying unsolvable CAPTCHAs that interfered with Real Time’s ability to access the data of its skilled nursing facility customers that utilized PCC. As Judge Xinis wrote in the opinion, “No evidence supports that PCC had any legitimate good faith use for wholly inscrutable CAPTCHAs which, by definition, blocked Real Time from getting the very records it needs to exist….But even more damning is the timing of such deployments, which support that PCC used those CAPTCHAs as a device to hamstring or eliminate Real Time as a competitor.” Keep reading for additional details regarding Real Time’s complaints against PointClickCare.
Update: On August 19, 2024, PointClickCare filed a Motion to Expedite Appeal with the United States Court of Appeals for the Fourth Circuit.
HIPAA Reproductive Health Care Privacy – Attestation Template, Policy Samples, updated HIPAA policies, a HIPAA-New Jersey Reproductive Health Care Law crosswalk, and more!
June 25, 2024 has arrived! This means that the Final Rule for HIPAA Privacy to Support Reproductive Health Care Privacy is officially in effect, and HIPAA covered entities and business associates may now begin implementing its new requirements! But there are still many questions about how some of the new requirements should be implemented. Among those giving covered entities and business associates the most angst is the new Attestation requirement.
Who’s On First? Confusion Continues About Who Should be Reporting the Change Healthcare PHI Breaches (UPDATED)
What should covered entity healthcare providers be considering and doing, especially where Change Healthcare has yet to take any affirmative breach notification actions? In this post, I take a deeper dive into key issues and share suggestions on steps covered entities may wish to take in order to manage ongoing uncertainties and risks that continue to simmer as a result of the Change Healthcare incident.
42 C.F.R. Part 2 Final Rule Amending Privacy of Substance Use Disorder Records Released.
The Final Rule amending 42 CFR Part 2 finalizes changes that will align uses and disclosures of Part 2 information with HIPAA for treatment, payment & health care operations. Part 2 providers and others who must comply with Part 2 and this Final Rule have two (2) years to get into compliance. Read more about the changes and how we can help with compliance.
Meet New Jersey’s Brand New Data Privacy Act and Its Impact on Healthcare Organizations & Others
The New Jersey Data Privacy Act (NJDPA) was enacted on January 16, 2024. Although PHI collected by a HIPAA CE or BA is excluded from the NJDPA HIPAA CEs and BAs are NOT wholly excluded from compliance with the NJDPA. Also, HHS’ recent problematic interpretation that IP addresses collected by a healthcare provider’s website may be PHI adds even more complexity in interpreting the NJDPA.
American Hospital Association Sues HHS for its HIPAA Online Tracking Guidance
The American Hospital Association, joined by a few others, has sued the federal government to enjoin them from enforcing their published Guidance on “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates.”
Hefty Monetary Disincentives Proposed for Health Care Providers Engaged in Information Blocking – But Not Every Provider Is on the Hook.
The Proposed Rule for enforcement is out, and the potential financial “hit” that health care providers may face if the OIG finds them to have violated the Information Blocking Rule (IBR) could be substantial, but don’t get spooked. The reach of the proposed enforcement has limitations. Read more to find out why.
State HIE Sued for Alleged “Unauthorized” Use of PHI for Research
On January 3, 2025, a significant lawsuit was filed against a state HIE. The case was brought by a former employee and whistleblower who alleges that the HIE permitted unauthorized access and use of PHI for research purposes in violation of federal and state law, as well as operational policies. Although the facts that are currently known to the public are not sufficient to conclude whether or not HIPAA’s standards applicable to research were met, this case has the potential to influence not only the immediate parties involved but also broader interpretations of HIPAA compliance and enforcement in research settings. At a minimum, the case serves as a reminder that HIEs should be taking proactive steps to ensure that their internal policies, data use agreements, and HIPAA BAAs explicitly address research-related and similar activities in compliance with federal and state laws, including HIPAA.
TEFCA Anticipated to Grow in 2025
Since TEFCA went live in December 2023, eight (8) organizations have been designated as Qualified Health Information Networks (QHINs). Each QHIN is a large information network that represents up to hundreds of HINs, health systems, public health agencies, payers, and IT vendors. Epic and Carequality recently announced that they would align their frameworks with TEFCA. TEFCA’s growth will be further supported by regulatory measures to incentivize network participation, such as the Information Blocking Rule.
Health Data, Technology, and Interoperability Rules, HTI-1, 2, & 3
The landscape of health IT regulation just took another significant leap forward. In the final days of 2024, federal regulators dropped two game-changing rules—HIT-2 and HTI-3—adding to the foundation set by HTI-1. Together, these regulations are reshaping how healthcare organizations approach interoperability, data sharing, and compliance in an era of rapidly evolving technology. But what do these latest rules really mean for healthcare providers, developers, and patients? Let’s break down the impact and key takeaways you need to know.
OCR Sees Uptick in Ransomware Incidents
During the Fall 2024, the HHS OCR concluded 3 investigations resulting in settlement payments relating to ransomware incidents. In all three instances, OCR found that the entities that encountered the cybersecurity incidents had not conducted a compliant risk analysis and did not sufficiently monitor their health information systems’ activity. there has been a 264% uptick in large ransomware breaches since 2018.
Texas Sues to Block new HIPAA Reproductive Health Care Rule
Texas Attorney General, Ken Paxton, has sued HHS alleging that the HIPAA Reproductive Health Care Privacy Rule amendments infringe on the state’s investigative authority and that the HIPAA statute does not grant sufficient authority to HHS to promulgate such a rule. Texas is seeking an injunction against enforcement of the final rule.
Lessons Learned from Real Time vs. PointClickCare: Mind your Information Blocking Ps and Qs
A federal district judge has granted preliminary injunctive relief to Real Time Medical Systems, Inc. (“Real Time”) barring the defendant, PointClickCare (“PCC”), from deploying unsolvable CAPTCHAs that interfered with Real Time’s ability to access the data of its skilled nursing facility customers that utilized PCC. As Judge Xinis wrote in the opinion, “No evidence supports that PCC had any legitimate good faith use for wholly inscrutable CAPTCHAs which, by definition, blocked Real Time from getting the very records it needs to exist….But even more damning is the timing of such deployments, which support that PCC used those CAPTCHAs as a device to hamstring or eliminate Real Time as a competitor.” Keep reading for additional details regarding Real Time’s complaints against PointClickCare.
Update: On August 19, 2024, PointClickCare filed a Motion to Expedite Appeal with the United States Court of Appeals for the Fourth Circuit.
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