Mar 25, 2025 / By

Battle of the Bots Continues…Fourth Circuit Affirms Preliminary Injunction Against PointClickCare

Continuing the saga of Real Time and PointClickCare in the battle of the bots, the U.S. 4th Circuit recently affirmed a preliminary injunction granted in favor of Real Time against PointClickCare, finding, among other things, that PointClickCare was unable to meet a burden of proof that it met its claimed Exceptions to Information Blocking. Therefore, documentation will be critical for actors who may find themselves having to defend similar claims.

Mar 9, 2025 / By

Preventing IAS from Becoming a Trojan Horse

Last week, I attended HIMSS 2025 in Las Vegas and came away with four big themes that stood out for me: the industry’s growing focus on Individual Access Services (IAS) and rock-solid identity verification, the push to expand non-treatment use cases for interoperability (like payment and healthcare operations), the urgent need for modernized consent management, and the overarching importance of trust to tie it all together. Yet of all these, for me, IAS is the real showstopper: if we don’t get identity and access right, the rest of our digital transformations—from AI-driven insights to cross-network data sharing—could quickly unravel. In today’s post, I want to zero in on IAS—where it fits into HIPAA’s right of access, where personal representatives enter the picture, and why it risks becoming a Trojan Horse for unauthorized data if we don’t take the proper safeguards.

silhouette of woman holding rectangular board

Mar 2, 2025 / By

NOW LIVE! The Updated 42 C.F.R. Part 2 Helper is Available!

The wait is finally over!! Our brand-new, UPDATED 42 C.F.R. Part 2 Helper compliance package is now live for current members of Legal HIE. Loaded with carefully crafted checklists, tools, sample forms, policies, and training resources, all updated for the Part 2 Final Rule, it’s just what the doctor ordered for every organization to stay miles ahead of the February 16, 2026 compliance deadline! Read our new blog post for more information about what’s included with our Part 2 Helper and to get access to a sample checklist to update your Part 2 consents!

42 C.F.R. Part 2 Final Rule Amending Privacy of Substance Use Disorder Records Released.

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

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.

When AI Denies Your Healthcare: The UnitedHealthcare Lawsuit and the Legal Dangers of AI in Medicine

When AI Denies Your Healthcare: The UnitedHealthcare Lawsuit and the Legal Dangers of AI in Medicine

icial intelligence (AI) is supposed to make healthcare smarter, more efficient, and—ideally—better for patients. But as UnitedHealthcare Group (UHG) recently learned, AI can also go horribly wrong, leading to denied care, regulatory scrutiny, and class-action lawsuits. Today’s posts breaks down what happened in the UHG case, what it reveals about some of AI’s legal minefields, and how healthcare organizations can avoid becoming the next target of an AI-related lawsuit.

Is Your Organization Paying for the Cost of Health Care? You Might be Responsible for a Health Plan with HIPAA Compliance Obligations.

Is Your Organization Paying for the Cost of Health Care? You Might be Responsible for a Health Plan with HIPAA Compliance Obligations.

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.

Penalties for Violation of the Information Blocking Rule Start Today!

Penalties for Violation of the Information Blocking Rule Start Today!

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.

WEBINAR: Managing Risk with Online Tracking Technologies

WEBINAR: Managing Risk with Online Tracking Technologies

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.

Genetic Testing Company Violates Privacy and Security Policies, FTC Says.

Genetic Testing Company Violates Privacy and Security Policies, FTC Says.

Genetic testing companies, and those who partner with them, must take care to ensure that the scope of how consumers’ sensitive data is used and shared in the future aligns with the scope of consent that was granted by the consumer at the point of collection. The FTC found that a California-based genetic testing company informed consumers that it would only share consumers’ sensitive health and other personal information “in limited circumstances,” but then expanded sharing such information with new third parties, like supermarket chains. The FTC has now stepped up to protect consumers’ sensitive genetic information.

Is Your Organization Paying for the Cost of Health Care? You Might be Responsible for a Health Plan with HIPAA Compliance Obligations.

Is Your Organization Paying for the Cost of Health Care? You Might be Responsible for a Health Plan with HIPAA Compliance Obligations.

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.

Penalties for Violation of the Information Blocking Rule Start Today!

Penalties for Violation of the Information Blocking Rule Start Today!

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.

WEBINAR: Managing Risk with Online Tracking Technologies

WEBINAR: Managing Risk with Online Tracking Technologies

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.

Genetic Testing Company Violates Privacy and Security Policies, FTC Says.

Genetic Testing Company Violates Privacy and Security Policies, FTC Says.

Genetic testing companies, and those who partner with them, must take care to ensure that the scope of how consumers’ sensitive data is used and shared in the future aligns with the scope of consent that was granted by the consumer at the point of collection. The FTC found that a California-based genetic testing company informed consumers that it would only share consumers’ sensitive health and other personal information “in limited circumstances,” but then expanded sharing such information with new third parties, like supermarket chains. The FTC has now stepped up to protect consumers’ sensitive genetic information.

AHA Writes Letter to HHS and Pushes Back on OCR’s Online Tracking Guidance

AHA Writes Letter to HHS and Pushes Back on OCR’s Online Tracking Guidance

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.

FTC Finds that Ovulation Tracking App Violated the Health Breach Notification Rule

FTC Finds that Ovulation Tracking App Violated the Health Breach Notification Rule

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.

ONC Says “Vetting” Mobile Apps is Information Blocking

ONC Says “Vetting” Mobile Apps is Information Blocking

ONC says actors that require third-party apps to be “vetted” by them for security reasons before allowing patients to use such apps to receive EHI via API technology certified to the Standardized API certification criterion is likely to be information blocking. However, my concern with relying solely on the security criteria required for API certification is that it is too low of a bar to adequately protect patients and other individuals from developers of apps that fail to keep promises to keep individuals’ information confidential.

ONC Publishes New FAQs on Information Blocking focused on the Privacy Exception.

ONC Publishes New FAQs on Information Blocking focused on the Privacy Exception.

The Office of National Coordinator says it receives a lot of questions regarding how the Information Blocking Rule is supposed to work in tandem with the HIPAA Privacy Rule and other federal and state laws governing privacy and confidentiality. Their new FAQs aim to help clarify when actors can choose to not respond to a request for access, exchange, or use of electronic health information.

ONC Vindicated. Patients Want Immediate Access to Test Results

ONC Vindicated. Patients Want Immediate Access to Test Results

JAMA published a study earlier this week finding more than 95% wanted immediate access to test results. However, when speaking to ONC, the study’s lead researcher specifically noted that although 95.3% of patients who received abnormal test results responded that they still would like to continue to receive immediately released results, this was associated with nearly twice the likelihood of worry compared to respondents who received normal results.

FTC Orders BetterHelp Health App to Pay $7.8M for Sending User Data to Facebook & Snapchat

FTC Orders BetterHelp Health App to Pay $7.8M for Sending User Data to Facebook & Snapchat

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.

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