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Jan 31, 2025 / By

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.

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Jan 6, 2025 / By

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.

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Dec 16, 2024 / By

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.

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.

Is Your Organization Ready for an OCR HIPAA Compliance Review re: Use of Online Tracking Technology?

Is Your Organization Ready for an OCR HIPAA Compliance Review re: Use of Online Tracking Technology?

On December 1, 2022, OCR released a “guidance” Bulletin re: “Use of Online Tracking Technologies by HIPAA Covered Entities and Business Associates.” From it, we learned (among other things) that OCR believes that an individual’s IP addresses and geo location, collected by a regulated entity’s website, is protected by HIPAA. Now, we have come to learn that HIPAA compliance investigations by OCR are already underway concerning this topic. Are you ready?

HAPPY NEW YEAR!  A LOT will be happening in 2023!

HAPPY NEW YEAR! A LOT will be happening in 2023!

The New Year is finally here, and I believe that there will be a LOT going on in 2023!  Here are just a few of the things that Legal HIE is looking to stay on top of for our readers this year . . .

Are We Getting Closer to Alignment of 42 CFR Part 2 & HIPAA?

Are We Getting Closer to Alignment of 42 CFR Part 2 & HIPAA?

SAMHSA finally fulfilled its duty under the CARES Act & releases a Proposed Rule “Confidentiality of Substance Use Disorder (SUD) Patient Records” amending the Part 2 rules in line with the CARES Act’s requirements. This is the 4th overhaul of the Part 2 Rule in 5 years…

Information Blocking is No Longer Limited to USCDI

Information Blocking is No Longer Limited to USCDI

Today, the Information Blocking spigot has officially opened. The Content & Manner Exception no longer applies; now, all electronic health information (EHI) cannot “blocked” if requested (unless another exception applies).

Summary List Update of COVID19-related Federal Actions Relevant to Healthcare

Summary List Update of COVID19-related Federal Actions Relevant to Healthcare

As efforts at the federal and individual states level evolve every day at almost a breakneck pace to address challenges and needs related to the COVID-19 outbreak, here is a updated running list of some of the top actions taken at the federal level that we thought would be helpful to the healthcare industry (Caveat, this is not an exhaustive list): 

CMS Releases Hospital COP Event Notification FAQs; Interpretive Guidance

CMS Releases Hospital COP Event Notification FAQs; Interpretive Guidance

On May 1, modifications to the Medicare Conditions of Participation (“CoPs”) went into effect, requiring certain electronic event notifications for admissions, discharges and transfers (“ADTs”) to and from hospitals, critical access hospitals and psychiatric hospitals. To provide guidance to hospitals and state surveyors, CMS released several FAQs as well as interpretive guidance last week to be published in the State Operations Manual.

Hospitals are required to make a “reasonable effort” to ensure that notifications are sent to post-acute care services providers and suppliers, and other practitioners and entities, which need such notifications for treatment, care coordination or quality improvement. Under the new CoP, ADT notifications must be sent for all emergency department and inpatient patients where the hospital, critical access hospital or psychiatric hospital maintains an electronic medical record or administrative system.

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.

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