TEFCA’s October 26 compliance deadline is directed at QHINs, but organizations connected through them should be paying attention, too. A restriction further up the network could disrupt your access even if your organization followed the rules. With federal oversight expanding and data access disputes landing in court, participants may also need to explain what happened to records they exchanged long before this deadline.
Time is up, and the enforcement infrastructure is now live. OCR’s complaint portal is open to 42 CFR Part 2, and Part 2 breach reporting is no longer a future workflow. A live portal changes behavior: it lowers the friction to file, increases complaint volume, and accelerates how quickly organizations receive the familiar “we have received a complaint, please explain” letter. If you are a Part 2 program, a QSO, or a lawful holder (including many HIPAA covered entities and business associates), this is the moment Part 2 stops being a policy project and becomes immediate operational exposure.
HHS has declared that the “warning period” for information blocking is over, putting HIEs, HINs, developers, and providers squarely in the path of active enforcement. With OIG empowered to levy million-dollar penalties, ONC able to strip certifications, and CMS now finalizing monetary disincentives for certain providers, the consequences are real and far-reaching. At the same time, long-standing practices, such as conservative privacy policies or restrictive BAAs, may suddenly collide with federal interoperability mandates. This article examines the new enforcement posture, the risks and dilemmas it creates, and what health information networks and their provider members must do to prepare.
Calendar year 2024 brought a range of high-impact HIPAA enforcement actions from the U.S. Department of Health and Human Services (HHS) Office for Civil Rights (OCR). By the year’s end, OCR had collected over $9 million through various settlements and final determinations. Interestingly, 2024 stands out for having the most final determinations (i.e., definitive impositions of a Civil Money Penalty) in OCR’s HIPAA enforcement history. However, it remains the case that most matters are resolved cooperatively through settlement agreements. Across hospitals, nursing facilities, EMS providers, physician offices (including dental and specialty practices), and even a health care clearinghouse, OCR’s actions highlighted the ongoing importance of thorough risk analyses, timely patient access to records, comprehensive workforce training, and secure system configurations.
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.
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.
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.”
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.
OCR reaches a new $1.3 million dollar settlement with a health plan for HIPAA violations. OCR says, “HIPAA-regulated entities need to be proactive in ensuring their compliance with the HIPAA Rules, and not wait for OCR to reveal long-standing HIPAA deficiencies.” Employers that offer Employee Benefits must evaluate if they are responsible for a health plan with HIPAA compliance obligations.
OIG’s authority to begin enforcement of the Information Blocking Rule begins September 1, 2023. Certain Actors subject to the Information Blocking Rule may be subject up to a $1 million penalty per violation! Actors need to be proactive in ensuring their compliance with the Information Blocking Rule and not wait for the OIG to discover them.
Attorneys at Oscislawski LLC together with the New Jersey Hospital Association present this highly informational Webinar on compliance steps hospitals can take to attempt to manage the risks associated with use of technologies that include online tracking tools.
After OCR created a Morton’s Fork for hospitals and health systems by publishing its HIPAA Guidance on the Use of Online Tracking Technologies, the American Hospital Association initially stayed out of the fray. Not any more. In its letter dated May 22, 2023, AHA makes its case to HHS as to why OCR’s Online Tracking Guidance should be suspended or amended.
The FTC releases its second enforcement action under the Health Breach Notification Rule in just over 3 months. This time, the FTC found that a fertility app called Premom shared sensitive fertility information with third parties for unauthorized purposes. While Premom told its users that it would not share their health information with third parties without users’ consent, it used third-party automated tracking tools known as software development kits (SDKs) which shared highly sensitive health information (e.g., data about an individual user’s sexual & reproductive health, pregnancy status etc.) for advertising and marketing purposes.
The FTC issued a proposed order requiring BetterHelp to pay $7.8 million to consumers to settle charges that it shared consumers’ health data with Facebook, Pinterest, Snapchat, and Criteo after promising to keep such data private and claiming it is “certified” as “HIPAA compliant.” The real juice of this case is in the FTC compliant — and HIPAA-covered providers, facilities & organizations can learn a lot about what to watch out for with health data Apps as we continue to march towards the FHIR.
The forecast for Arizona is thunderstorms, at least for at least one health care system. Last week, OCR announced a $1.25 settlement for HIPAA Security Rule violations brought to light by a cybersecurity hacking incident that took place over five years ago.
