On this episode of 1st Discuss Compliance, Kevin Chmura is joined by Rachel Rose, JD, MBA, as they talk about latest modifications to the HIPAA Privateness Rule to Help Reproductive Well being Care and Privateness in relation to latest courtroom rulings. This rule, which went into impact in April of 2024, nonetheless has sure elements which practices have to learn about and cling to heading into 2026.
Find out about how these rulings are, and can, affect this vital rule, and what HIPAA regulated organizations have to know regarding these updates. As well as, hear about what could be coming in the way forward for not solely reproductive well being rules, but in addition varied different areas of healthcare almost about privateness.
Subscribe: Apple Podcasts | Spotify | Amazon Music | Android | E-mail | | Extra
Kevin Chmura
Hi there and welcome to at the moment’s episode of First Discuss Compliance. I’m your host, Kevin Chmura, CEO of First Healthcare Compliance and Panacea Healthcare Options. And I’m excited to deliver you an vital dialogue a couple of main authorized growth that impacts all HIPAA regulated entities. By the use of background, on June 18th, 2025, the U.S. District Court docket for the Northern District of Texas issued a nationwide order putting down the HIPAA Privateness Rule Amendments designed to strengthen reproductive well being care privateness.
The amendments had been necessary since December 2024, and this courtroom resolution has created a brand new compliance problem for coated entities and enterprise associates. To assist us perceive what occurred, why it issues, and what organizations ought to do now, we’re joined by our professional visitor. Rachel V. Rose, J.D. MBA, who’s a number one authority on HIPAA healthcare privateness regulation.
When you hearken to our podcast, you’ve heard Rachel many instances. In actual fact, we’ve mentioned this specific subject, or points round it, fairly lately. So it’s nice to have her again. So, Rachel, welcome again. Thanks for coming to share your experience with us at the moment.
Rachel V. Rose
Kevin, it’s all the time my pleasure and thanks for having me again.
Kevin Chmura
Yeah, your content material is all the time closely consumed as a result of it’s crucial. So we thanks for being right here. So, possibly in all probability greatest technique to simply begin off is that if I can ask you to only briefly clarify what the U.S. District Court docket’s order did, why it’s important and who it applies to?
Rachel V. Rose
Completely. So on June 18th of this 12 months, the USA District Court docket for the Northern District of Texas and particularly the Amarillo Division within the case caption Carmen Purl et all the USA Division of Well being and Human Companies et all. And for many who have an interest, that case quantity is 224 sprint CV, Sprint 228, Sprint Z and ta Z.
It correlates to the choose at any time you see initials or an preliminary after a case quantity, it’s the choose. And I’ll simply merely check with this case because the Purl case. Purl. Mainly, what the courtroom did was to difficulty an order vacating the April sixteenth, 2024 HIPAA Privateness Rule to assist reproductive well being care and privateness.
And for simplicity’s sake, I’ll simply name that the HIPAA reproductive privateness rule. And principally what it did was to go away intact the necessities concerning the updates to the discover of privateness practices that are due in early 2026. And to concentrate on that, there actually hasn’t been any steerage but from HHS. However each coated entity and enterprise affiliate and subcontractor must be conscious that the discover of privateness practices updates, which actually incorporate the HIPAA provisions together with a 42 CFR half two rules, are nonetheless in play, and the half two rules particularly relate to the substance use dysfunction regulation.
In order that’s one thing that once more, coated entities, enterprise associates and subcontractors ought to placed on their calendar and search for updates from First Healthcare Xompliance. Each time HHS releases some extra steerage associated to what ought to be included. As many know who’ve been in healthcare a very long time. Oftentimes HHS and SAMHSA, the Substance Abuse and Psychological Well being Companies Administration, which oversees 42 CFR half two, will difficulty steerage or kind sorts of agreements or different related compliance objects.
One nice instance is the Enterprise Affiliate Settlement. In order that’s the half that ought to be calendar and folks ought to guarantee that they’re staying abreast of. Now that brings us to what was vacated. And so principally, procedurally, the courtroom granted the plaintiff’s movement for abstract judgment. And for these non-lawyers, abstract judgment is out there when there isn’t a difficulty of a cloth truth.
In essence, it’s judgment as a matter of regulation, and in doing so, denied the defendants, which on this case is the USA Division of Well being and Human Companies movement to dismiss for lack of jurisdiction and the precise part that was vacated pursuant to 5 U.S.C. Part 7062, apart from the modifications that I discussed to C.F.R. Part 164.520 with the discover of privateness practices are the provisions of related to what had been 45 C.F.R. part 1604520b, 1, 2, F, G, and H, And so for many who had been accustomed to what was required below these specific objects, that needed to do with the reporting necessities and the attestation necessities below regulation, and that’s distinct from the regulation enforcement exception.
A few objects which can be additionally notable, Kevin, and different healthcare attorneys within the area have additionally honed in on this, is that the plaintiff indicated, and the courtroom honed in on this, saying that below the Administrative Procedures Act that the federal government exceeded its rulemaking authority. Nonetheless, a number of legal professionals are of the opinion that Congress merely barred guidelines that supersede state statutes, not people who add affordable situations.
And in order that’s one thing that I need to emphasize to, as I usually do in our discussions that state legal guidelines can’t be missed.
Kevin Chmura
In order that’s important on condition that that you just and I not that way back mentioned a number of the updates to HIPAA 2024 guidelines. So it’s attention-grabbing that we’re speaking about it this this quickly thereafter form of thought that we had been a bit of bit settled there. So possibly simply do a fast test. Are there another reproductive rights associated lawsuits which can be important that that we must always learn about and be being attentive to?
Rachel V. Rose
I’d say the one which could be very distinguished is the latest Supreme Court docket opinion in United States versus Committee, The lawyer normal and reporter for the State of Tennessee. And what’s notable about that case is that it was a 6-3 opinion which upheld Tennessee’s ban on puberty blockers and hormone remedy for transgender youngsters. Texas additionally really had an identical regulation.
And final 12 months, in 2024, the Texas Supreme Court docket upheld a state regulation banning medical doctors from prescribing gender affirming care to transgender minors and a state coverage increasing the definition of kid abuse to incorporate gender affirming care stays blocked following a state courtroom of appeals resolution final 12 months. So notably, the courtroom, really, has agreed to listen to a few different transgender associated circumstances, together with transgender, take part in in feminine sports activities.
And so that is an space that ought to be learn at the side of any HIPAA privateness, any regulation enforcement exception, which is discovered below the HIPAA rules at 164.51 Q And simply actually be conscientious and cautious about what the person states are requiring, in addition to following the USA Supreme Court docket’s ruling. As a result of this specific case, the courtroom held that Tennessee’s regulation prohibits sure medical therapies for transgender minors is just not topic to heightened scrutiny below the equal safety clause of the 14th Modification and satisfies rational foundation evaluation.
So at any time when one seems at civil rights points below a structure evaluation, we’ve got what’s often called strict scrutiny. We’ve got intermediate scrutiny, after which the bottom degree of evaluation is rational foundation, strict scrutiny. We sometimes see utilized to these objects which can be expressly talked about within the 1964 Civil Rights Act: race, gender, faith. And for many who learn any employment settlement with the nondiscrimination provisions, those self same objects are included there as effectively.
Intermediate scrutiny is a degree under, after which we’ve got rational foundation, which is the bottom degree of evaluation. I’d additionally add that in relation to a number of the 14th Modification points and strict scrutiny, one can’t overlook any government order that’s being issued proper now. And because it pertains to discrimination and the DEI initiatives, the manager orders that had been printed in January of 2025 that relate to this expressly upheld the Civil Rights Act of 1964.
So you continue to can’t run afoul of that.
Kevin Chmura
Wow. So simply to make clear in query for non-attorney, as a result of that’s wonderful. So with respect to scrutiny or actually any latest Supreme Court docket circumstances, effectively, any of these have or might have an effect on an attraction or the last word consequence of the parole case.
Rachel V. Rose
I feel that’s an excellent query for 3 fundamental causes, Kevin. At the start, the Purl case. The choose used, as I discussed earlier, the Administrative Procedures Act, and that’s very related due to the latest Supreme Court docket Trump versus Costa Inc. And what’s related about Costa Inc, although that’s a very completely different space of regulation, is that the Supreme Court docket case, Costa principally held that nationwide injunctions are invalid they usually can’t be issued.
They’re solely particular to the person events to that case proper. That was introduced, which generally is smart at any time when I’ve utilized in injunctive aid on the state courtroom degree, it’s to both get a short lived maintain, so to talk, or to have conduct cease, nevertheless it solely pertains to the events. It doesn’t transcend that. I can’t say each oil firm, proper, or each healthcare firm is concerned on this. And so principally what Costa did, and there’s been a number of debate over nationwide injunctions by federal courts of their nationwide applicability for a really very long time. So this difficulty actually isn’t new. However Costa affirmatively said that nationwide injunctions can not be issued, they usually’re solely particular to the events.
What’s related to the Purl case is that the courtroom additionally mentioned the Administrative Procedures Act and mentioned this doesn’t relate to the Administrative Procedures Act, and I imagine it’s footnote ten within the Costa opinion that highlights that. And what’s notable is that even a number of the entities who had been concerned in a number of the nationwide injunctions honed in on that truth.
So will we see an attraction by the USA authorities? Based on the HHS web site, they’re evaluating their choices. That’s the primary merchandise. The second merchandise is since nationwide injunctions at the moment are not permissible, how can a single district courtroom’s ruling invalidate a specific regulation and have that apply to the remainder of the nation? When is even non-lawyers know for those who’re in a specific jurisdiction?
Usually the district courtroom’s opinion is just binding not solely on the events, nevertheless it then turns into precedential inside that individual district. So each different case that had been to comply with within the Northern district of Texas, for instance, must cite the Purl case. Now up on attraction, as soon as an appellate courtroom guidelines on one thing that then applies to each district courtroom, which is below that individual circuit after which if the Supreme Court docket guidelines, as we noticed within the Dobbs case, proper. Which overturned Roe or low agency, which is the case. So the Loper Shiny versus Raimondo case, which honed in on the Administrative Procedures Act and overturned the Chevron Doctrine, no less than partially, the Supreme Court docket has the last word authority to invalidate a regulation or regulation as it could be utilized throughout your entire nation.
So I do assume that we are going to see probably the federal government attraction the district courtroom’s opinion, though there’s a possible coverage difficulty there. After which the opposite merchandise is we might see different circumstances come up below this that problem this district courtroom out of a distinct circuit or district inside the USA.
Kevin Chmura
It’s attention-grabbing and nationwide bans are a scorching subject of late I’m certain in your world particularly and so it’s, it’s not essentially all the time black and white as you level out, which is attention-grabbing possibly we will, that’s all tremendous useful. Maybe we change gears just a bit bit and assume via.
Okay. We all know the place we’re proper now. What ought to we be occupied with doing? So I suppose possibly to border it as a query with this order in place now, what ought to HIPAA regulated entities, coated entities, enterprise associates alike, however what are they nonetheless required to do with respect to reproductive well being info because it stands now?
Rachel V. Rose
Nicely, one merchandise that stood out to me concerning the Purl case was the definition of a kid. And I actually do assume there’s a number of interaction there with a wide range of completely different state legal guidelines, as a result of even for those who take a look at the USA Census Bureau, they don’t embody unborn people within the definition of a kid. So a fetus is just not included there.
But, Purl reached the other conclusion. Proper. And the plaintiffs within the Purl case form of raised that within the reporting of kid abuse obligations. So to reply your query, what stays before everything and for these people who’re purchasers of First Healthcare Compliance, I created a revised FAQ concerning the privateness rule and principally, in gentle of the opinion because it stands now, as a result of we’ve got no different circumstances, we don’t have a Fifth Circuit opinion, we don’t have a United States Supreme Court docket opinion on the APA with the ability to be utilized at a district courtroom degree to overturn a whole statue and make it invalid.
I’d advocate that people put a placeholder on what was beforehand solely required to be carried out by December of 2024, apart from these discover of privateness practices, Kevin, and I’d additionally guarantee that individuals are very conscious of the obligations below the regulation enforcement exception which have been in place for over 20 years. In order that’s not new and in compliance with the regulation enforcement exception.
I particularly would initially go to 164.512 F12 in that pertains to a courtroom or courtroom ordered warrant or subpoena or summons issued by a judicial officer, a grand jury subpoena, or an administrative request for which response is required by regulation, together with an administrative subpoena or summons a civil or a certified investigative demand or an identical course of below regulation, offered that first the data sought is related and materials to a authentic regulation enforcement inquiry.
The request is particular and restricted in scope to the extent moderately practicable, in gentle of the aim for which the data is sought, and de-identified info couldn’t be moderately used. A few examples associated to which have really come out of State Supreme Courts and one case that could be very a lot an instance of not adhering to the regulation enforcement exception that bought a apply in scorching water is the civil case, and it’s the Byrne case, versus Avery Middle for Obstetric and Gynecology.
It’s case quantity 18 904. It was a Connecticut Supreme Court docket case and it was selected November eleventh of 2014. And principally, as everybody in healthcare ought to know, via their coaching, earlier than you ship any HIPAA info out, it’s best to take a look at that affected person or the authorized representatives. HIPAA approved the affected person and see if any particular person or entity is excluded.
So what occurred within the Connecticut case was {that a} girl realized she was pregnant and expressly said on her HIPAA authorization that no supplier was to launch her protected well being info to the kid’s father with whom she was not in a relationship. So the apply will get served with a subpoena from the kid’s father, and as a substitute of going to a lawyer, the apply merely launched the medical data.
And so the Connecticut Supreme Court docket mentioned, Hey, from our evaluation of the document within the current case, it seems that the defendant didn’t even adjust to the face of the subpoena, which is required by the custodian of data for the defendant to seem in individual earlier than the lawyer who was issued the subpoena. As an alternative, the defendant mailed a duplicate of the plaintiff’s medical data on to the courtroom.
After which secondly, though it was a civil case, the prices to the plaintiff by way of shedding belief within the healthcare system and to the apply within the type of a lawsuit is important. And there’s a provision within the regulation enforcement exception which really requires a coated entity to contact the affected person first. And so not assembly these elementary necessities of the regulation enforcement exception is important and one thing that’s associated to that.
Lastly, Kevin, which dovetails into the compliance, is totally ensuring that you just’re two issues: state legal guidelines once more after which secondly, it needs to be, is the demand that has been acquired compliant with due course of. So is it official? Is it a response required by regulation, issues of that nature? And I all the time advise all purchasers to completely attain out to an lawyer while you get any kind of request for HIPAA info that’s indirectly from the affected person.
Kevin Chmura
And Rachel, I take that recommendation myself from you and attain out to you at any time when I’ve a query. In order that’s wonderful recommendation for the listeners. So the Connecticut circumstances is a superb instance and I suppose possibly it results in a extra apparent query or one thing that’s a bit of extra sensible for folks. Actually maintaining on state legal guidelines and rulings, that’s vital, that requires actually the experience of an lawyer.
I ponder for those who can provide the listeners any recommendation on any quick steps they need to be taking to regulate their use, their HIPAA insurance policies, procedures and coaching in gentle of this resolution and your entire surroundings? I imply, that’s actually the place they’ll have essentially the most quick affect on their organizations. Any recommendation for folk?
Rachel V. Rose
Completely. In order I discussed, I’d put an replace in pink in any coverage modifications that had been put into place as required in December of 2024. So simply place maintain it and, as I did in your purchasers in our mannequin insurance policies and procedures, simply put that this replace the insurance policies and procedures pursuant to this courtroom ruling after which word that there might be modifications and that appeals and HHS, the panorama must be stayed abreast of to understand how this will shift.
Proper. As a result of it could shift again. We don’t, we don’t know. In order that’s the very first thing. The second factor, once more, is to reiterate the regulation enforcement exception and as you additionally know, Kevin, below HIPAA, there’s the flexibility for any supplier to probably report youngster abuse. Proper. Or suspected youngster abuse or below Tarasov, which is a California Supreme Court docket circumstances, Tarasov One and Tarasov 2, a supplier has the choice of notifying regulation enforcement if an individual is a threat to themselves or to a different individual. So appreciating different objects which can come into play after which studying what’s often called, Amparo Materia is the Latin, or the at the side of the state regulation for what’s a toddler proper below state regulation and what constitutes youngster abuse?
What necessities are in place for reporting that? As a result of what you need to keep away from and we’ve seen this already, not solely on the reporting of kid abuse, however there was that case out of Ohio when a medical skilled was naturally struggling a miscarriage and really miscarried at dwelling as a result of the hospital despatched dwelling. And in consequence, there was a felony investigation into abuse of a corpse.
Now, that was not upheld. The post-mortem revealed that the miscarriage was, in truth, pure. It wasn’t induced by any chemical which might have run afoul of that individual state’s regulation. And in consequence, and rightly so, the sure entities are being sued by this particular person. So it’s a steadiness of the potential hurt to people. And that potential downstream legal responsibility in addition to youngster abuse and potential Tarasov abuse reporting.
Kevin Chmura
Yeah. Wow. So nice, nice recommendation as standard. So, Rachel, we up so far, I needed to ensure we stored the whole lot grounded in in what’s occurring now. Consider your professional recommendation, now I’m going to ask you to look into your crystal ball possibly, and get to the place of hypothesis. So relative to world, do you count on HHS to attraction the choice?
And in the event that they do, what would that course of seem like.
Rachel V. Rose
So, the method is one thing that’s set forth within the guidelines of process. And since the northern District of Texas falls below the umbrella of the Fifth Circuit, a discover can be filed within the district courtroom after which the attraction would finally be filed within the Fifth Circuit Court docket of Appeals. So whether or not or not HHS does that, I from my perspective and from different views that I’ve learn, there’s actually a rigidity right here on the general public coverage as a result of it’s reproductive healthcare associated.
However the truth that HHS does have some points to take care of, together with the definition of a kid, which is I discussed the U.S. Census Bureau defines in a different way, is one thing that we might see, one other merchandise that we might see probably as a case being introduced in one other district courtroom in one other circuit. And so we might see that being a difficulty or an attraction particular to the APA.
So I feel we’ve got a number of completely different choices that we might see play out. In the end, it’s on the discretion of the federal government after which another circumstances which can be introduced on this subject or the APA subject normally.
Kevin Chmura
Yeah, that was effectively mentioned. So possibly as we transfer to our closing, what I’ll ask you just a few extra kind of easy issues for sensible recommendation for our listeners. Do you assume there’s another potential future authorized or regulatory modifications they need to actually be watching out for? And possibly, two-part query, How do they keep knowledgeable and put together for any extra modifications within the space?
Rachel V. Rose
That’s an excellent query. I feel before everything, your main sources are your greatest sources. So I’d all the time take a look at state web sites, sometimes their very own HHS objects. I additionally would look to trusted companions akin to Panacea and First Healthcare Compliance. And for instance, AHEMA usually has actually good critiques and consultants. There are there’s Namaz. I imply, there are a number of actually good, respected third events which can be conscientious concerning the content material that they put out.
So making an attempt to remain abreast of the entire myriad of modifications could be daunting. However I’ll say appreciating the place to go in your personal state might be before everything what’s vital, as a result of as we’ve mentioned, a few of that is going to come back right down to the state degree as effectively. And that’s one thing that’s, you realize, I inform your purchasers the entire time and I’m very cautious at any time when I get requested inquiries to say state regulation might differ or alter the end result.
So it’s crucial that any coated entity or enterprise affiliate seek the advice of these state legal guidelines and the HHS web site.
Kevin Chmura
However that’s nice recommendation and I’ll add to it for our listeners case comply with Rachel as effectively. She lately authored an article on this precise subject, which was useful in me getting ready for this at the moment. So with that, Rachel, I say thanks very a lot as all the time, your professional recommendation right here is invaluable. This can be a shifting subject.
So what I’d say is for the listeners, listen. We’re more likely to put out extra content material on this face. Rachel, I’ll reserve the fitting to ask you to come back again and hold us up to date as a result of it appears like there will probably be extra to speak about relative to Purl and different areas. We’ve got loads occurring proper now.
So Rachel, thanks very a lot as all the time.
Rachel V. Rose
You’re very welcome, Kevin. And one factor simply to remember is that the reproductive healthcare definition that was initially issued was broadly outlined and really not solely thought of maternity care and contraception, it additionally impacted vasectomies, mammograms, sexually transmitted an infection screenings and in vitro fertilization, in addition to the gender affirming care, which we additionally mentioned.
Kevin Chmura
Wow, yeah, so and that’s the complexity of those points goes usually past simply the headline, which is why your recommendation is so useful for everyone. So thanks once more.
Rachel V. Rose
Thanks., and we’ll stay up for subsequent time, Kevin.
Kevin Chmura
Thanks. So to our listeners, we encourage you to evaluation your HIPAA insurance policies, procedures, and coaching supplies in gentle of those courtroom choices and keep knowledgeable on as authorized panorama modifications. So please listen. We’re right here for you, at First Healthcare Compliance and Panacea. Rachel is a superb useful resource for you as effectively. When you’d wish to be taught extra, simply go to our web site, at First Healthcare Compliance, which is 1sthcc.com. Or you may go to Panacea and comply with the hyperlinks for compliance or attain out to our staff at any time with questions. Don’t neglect to subscribe to 1st Discuss compliance in your favourite platform and by no means miss one other episode. Thanks for tuning in and we’ll see you subsequent time.
