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…
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.
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 . . .
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.
The Court of Appeals for the Fifth Circuit vacated the $4.3M penalty imposed on M.D. Anderson as arbitrary, capricious and contrary to law.
The new year has much in store for electronic health information exchange compliance! Today’s post provides an overview of anticipated changes to the health information regulatory landscape in 2021, including increased interoperability efforts and telehealth expansion due to the coronavirus pandemic. It is not surprising that many of the topics discussed below are a direct result of the interoperability requirements created by the 21st Century Cures Act (“Cures Act”) enacted in December 2016.
Seasons Greetings to all of our readers! First, we want to wish you and yours a holiday season filled with health, happiness and hope! We also want to thank you all for continuing to make Legal HIE such a popular and highly visited blog! It puts a smile on our face seeing so many of you enjoying our posts and returning to our site often!
As stockings are being hung by chimneys with care, we want to make sure you know that Legal HIE’s stockings are absolutely stuffed to the brim with tremendous tools, sample forms, polices and turn-key solutions that can help your organization stay on top of the most pressing compliance challenges, and ever-changing healthcare regulatory landscape. 2021 promises to be a year with many new and final regulations going into effect, and being released. The Legal HIE compliance library was created specifically for this purpose – to help busy and overwhelmed compliance officers and attorneys keep up with these changes by offering turn-key samples and solutions as a solid starting point.
Last Friday, the Office for Civil Rights (OCR) issued new Guidance on how HIPAA permits covered entities and their business associates to use health information exchanges (HIEs) to disclose PHI for the public health activities of a Public Health Authority (PHA). Specifically, it provides examples relevant to the COVID-19 public health emergency. OCR Director, Roger Severino, specifically notes that the Guidance was issued:
“to highlight how HIPAA supports the use of health information exchanges in sharing health data to improve the public’s health, particularly during the COVID-19 public health emergency.”.
Although much of the Guidance document simply reiterates the controlling HIPAA Privacy Rule provisions and definitions which have always afforded a mechanism through which covered entities (CE) and their contracted business associates (BA) can share ePHI with a public health authority for public health purposes, there are a few notable new take-away nuggets.
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 . . .
As the November 2nd deadline for compliance with ONC’s Information Blocking Rule nears, many health care providers – which are “Actors” subject to the Rule – are scrambling to reexamine their default settings for sharing various types of data, including lab results. In ONC’s Final Rule preamble, several commenters indicated that providers’ current organizational policies call for practices that delay the release of laboratory results so that the patient’s clinician has an opportunity to review the results before potentially needing to respond to patient questions, or has an opportunity to communicate the results to the patient in a way that builds the clinician-patient relationship.
Join me for a pair of 1.5hr Information Blocking Workshops designed to work thorough the nitty-gritty details of the Information Blocking Rule. The first Workshop will take place WEDNESDAY (9/30) so don’t delay! Workshops will include use cases and scenarios aimed at real challenges faced by health care providers looking to comply with these new regulatory standards for access and sharing of electronic health information. Registrants will receive 2 sample P&Ps, and much more!
Yesterday, all at once, OCR announced that it has entered into five new Resolution Agreements — each of them stemming from one or more violations of HIPAA’s right of access afforded to individuals. There are several interesting observations about these new cases that are worth taking note of.
After over almost four months of no new HIPAA Resolution Agreements or Civil Money Penalties, OCR quietly posted two new HIPAA settlement agreements at the end of July. At first glance, both appear to be “run-of-the-mill” cases with nothing much new to learn with the first one resulting in OCR finding that the covered entity failed to even complete a basic Security Risk Analysis and training of workforce, and the other involving – yes, yet again – a stolen unencrypted laptop. However, the second case in particular deserves closer examination where it has embedded in it more complex corporate structure and liability issues where it actually involved two legally separate covered entities that elected to designated themselves as a single covered entity for purposes of HIPAA. Let’s look at each case separately.
A preliminary class action data breach settlement involving UnityPoint Health should prompt health care organizations to take a second look at their breach insurance coverage as well as their contracts with vendors who process data on their behalf. Adequate cyber and breach insurance coverage is paramount and should be commensurate with the health care organization’s size, operations. Additionally, health care organizations should pay close attention to their vendor contracts, particularly limitation of liability clauses, hold harmless provisions and indemnification provisions in health IT and other contracts.
The HIPAA Enforcement Rule prevents the Secretary/OCR from assessing civil monetary penalties (CMP) against a covered entity or business associate if an Affirmative Defense can be established. A HIPAA violation that is corrected within 30 days of discovery can potentially insulate an organization from CMPs, provided certain requirements are met. But an organization has to make sure that it fits squarely within the requirements of these regulatory defenses to be fully insulated.