Beware! New Breach Reporting Obligations Under 42 CFR Part 2 — Even When HIPAA Wouldn’t Require It

Beware! New Breach Reporting Obligations Under 42 CFR Part 2 — Even When HIPAA Wouldn’t Require It

Until now, Part 2 programs had no duty to report breaches under Part 2—even if disclosures clearly violated the rule. That “free pass” ends in February 2026, when HIPAA’s breach reporting framework will officially be grafted onto Part 2. What does this mean for programs? A new world of reporting obligations, OCR enforcement, and tougher compliance decisions.

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Regulatory Roller Coaster: District Court Judge Vacates HIPAA Reproductive Health Privacy Rule

Regulatory Roller Coaster: District Court Judge Vacates HIPAA Reproductive Health Privacy Rule

On June 18, 2025, Judge Kacsmaryk of the U.S. District Court for the Northern District of Texas vacated key provisions of HHS’s HIPAA Privacy Rule that had imposed new federal protections for reproductive health care information. This means that HIPAA-covered entities must immediately stop requiring a HIPAA-compliant Attestation from requestors seeking PHI that includes (or is likely to include) reproductive health information. Covered entities must now also reevaluate their current processes for handling requests for PHI related to reproductive health information. However, if you operate in a state that has its own state-level reproductive privacy or provider shield law, those state protections still apply and may even require similar or stronger privacy safeguards.

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

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.

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Unmasking the Issues: The Final Resolution in the Epic v. Particle Health Dispute

Unmasking the Issues: The Final Resolution in the Epic v. Particle Health Dispute

In a decision that will have lasting implications for interoperability and health information exchange, earlier this month Carequality issued its Final Resolution in the dispute between Epic and Particle Health. This follows months of deliberation, multiple rounds of evidence submission, and deep scrutiny of the rules governing data sharing. This latest resolution delivers much-needed clarity on several key concerns—but it also introduces fresh questions around enforcement, reciprocity, and how trusted exchange will continue to evolve.

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Minnesota Supreme Court Finds State Law Permits Health Information to be Shared Because HIPAA Authorizes It

Minnesota Supreme Court Finds State Law Permits Health Information to be Shared Because HIPAA Authorizes It

The Minnesota Supreme Court held that HIPAA “authorizes” disclosures for purposes of state law and consent was not required for a hospital to disclose PHI to its institutionally related foundation for fundraising purposes. Other states might take a similar stance. The Information Blocking Rule (IBR) prohibits health care providers from interfering with the access and exchange of EHI in an unreasonable manner. State with laws containing similar “as authorized by federal law” exceptions to consent must be carefully considered when claiming the IBR’s Privacy Exception to “block” EHI.  

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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.

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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.

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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.

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How to Use the Privacy Exception to Deny an Abuser Access to EHI

How to Use the Privacy Exception to Deny an Abuser Access to EHI

When an Actor wants to potentially deny access of EHI to a person who is suspected of some type of abuse of the individual (the “Abuser”) whose EHI is being sought, the natural inclination is want to look to the Information Blocking (IB) Rule’s Preventing Harm Exception to justify such denial.  However, the IB Rule’s Privacy Exception offers additional options and, in certain ways, more flexibility for the Actor to deny a suspected Abuser’s request for EHI.  

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Threading the HIPAA Needle through Information Blocking to Block Patient Access when Data is Corrupted

Threading the HIPAA Needle through Information Blocking to Block Patient Access when Data is Corrupted

The Information Blocking (IB) Rule is intended to work in sync with HIPAA, including the “right of access” the Privacy Rule grants to patients with regard to access to their own protected health information (PHI).  However, as I continue to analyze how to implement various standards that overlap between these two regulations, questions about how to thread the needle on seemingly conflicting standards continues to come up. Today, I take a closer look at the difference between HIPAA’s “right of access” as compared to the Preventing Harm Exception found in the IB Rule. Specifically, this post considers how a covered entity health care provider . . .

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How the Preventing Harm Exception Changes HIPAA

How the Preventing Harm Exception Changes HIPAA

the “Preventing Harm Exception” under the Information Blocking Rule is not only the most challenging exception to apply, but also the most difficult to interpret – particularly where some of the standards do not exactly track HIPAA, and still other imprecise language ONC used has made its interpretation uncertain. In this post, I will attempt to distill the Preventing Harm Exception down to its basic elements, as well as point out issues in its interpretation to be aware of.

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A “Double-Double” Set of Proposed Rules from CMS & OCR Affecting Data Sharing & HIPAA

A “Double-Double” Set of Proposed Rules from CMS & OCR Affecting Data Sharing & HIPAA

Late last week, two new proposed rules were released which will affect the exchange of health information and HIPAA, among other things.  The CMS and OCR proposed rules come in at over 347 and 357 pages respectively – so that’s a lot of meat to digest!  At a high level, the CMS Proposed Rule aims to “improve the electronic exchange of health care data among payers, providers, and patients,” and “streamline processes related to prior authorization to reduce burden on providers and patients.” The OCR proposed changes to HIPAA take a bite out of patient access, minimum necessary, the HIPAA NPP and more . . .

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