The ONC Cures Act Final Rule (Cures Rule) is the biggest health care law you’ve never heard of. But it’s a law that’s going to fundamentally shift the way we see patients and their information. It will change how physicians talk to patients about information. It will shift the way health professionals connect patients to their information. So what is it and what does it mean for doctors and health systems? My first take on this groundbreaking mandate.

What is the ONC Cures Act Final Rule (Cures Rule)?

What is the 21st Century Cures Act Final Rule on Interoperability & Information Blocking? This federal mandate was created to prevent the blocking of electronic health information between health systems, apps and devices. That is, health organizations can’t interfere with the access, exchange or use of electronic health information. For patients this rule allows unfettered access to their personal health information — something that before took a whole lotta work. The Cures Act Final Rule (Cures Rule) from the Office of the National Coordinator for Health IT (ONC) kicks into effect November 2, 2020.

A word on the lingo: The 21st Century Cures Act, a bi-partisan law passed in 2016, includes a whole lot of stuff. The part about the electronic sharing of records is in the ONC Cures Act Final Rule, or the Cures Rule. I’ll use the Cures Rule from here on since that’s what we’re talking about.

The Cures Rule as the next iteration of the HITECH Act

Despite the best intentions of the Health Information Technology for Economic and Clinical Health (HITECH) Act, true health care information exchange across care settings has been something of a pipe dream. The Cures Rule is a critical first step in leveling the silos of health information under the excuse of protecting patient privacy.

The clock for enforcement of the Cures Rule started ticking when the rule was published in the federal register on May 1, 2020. Compliance with the information blocking portion of the law starts on November 2, 2020. There is a grace period of enforcement where health facilities can sort out the details without penalty.

This law is an historic step in patient access. It will forever change the way we see information and its relationship to patients. This is a bigger deal than most people think. In fact, it’s staggering how few health professionals understand how this will impact their work.

In fairness, maybe that’s because we really don’t know.

Two big chunks of ONC Cures Act Final Rule

There are different facets to the Cures Rule and you can poke around here for the skinny. I see a couple of major angles that will impact most physicians and hospitals:

• Access to clinical notes (ie, ‘open notes’)
• Immediate release of tests and studies.

Let me touch on these two effects and then tell you how it’s going to affect doctors and systems.

Opening notes

Under the Cures Rule systems are required to let patients see their clinic notes (There are eight kinds of clinical notes must be shared and you can find them listed here). And not just see them, but have them. When a doctor or practitioner has completed a note it will be accessible to patients through their secure, online portal.

This is a shocker for some health professionals: The patient actually reading the office note. But open notes is really not new. Over 250 health care organizations have already electively opened their notes to their patients. What’s new here is the federally mandated adoption for all clinicians. While health organizations once asked whether they should open their notes, the question moves now to how they do it.

Open notes is not new

The note transparency movement actually dates back to 2010 when the Beth Israel Deaconess Medical Center in Boston, Geisinger Health System in rural Pennsylvania, and Seattle’s Harborview Medical Center launched a study allowing 20,000 patients to read their clinic notes (funded by The Robert Wood Johnson Foundation’s Pioneer Portfolio, Drane Family Fund, and Koplow Charitable Foundation).

This effort to empower patients with their own notes has been fueled by the OpenNotes project, based at the Beth Israel Deaconess Medical Center, a Harvard Medical School teaching hospital. Click through to read an exhaustive list of published research around open notes. You can also find listed the dozens of prescient medical centers who have already opened their notes. So right now health systems without open notes are working overtime to figure out how they’re going to be compliant.

(Programming note: open notes refers to the general idea of notes being available to patients. OpenNotes refers to the research group specializing in this area of study who support this level of transparency.)

Opening notes involves more than flipping a switch

As a lot of systems are figuring out, opening notes to patients doesn’t happen overnight. Opening notes is an intentional process. It takes a lot more than just flipping a switch. It involves careful consideration of hospital’s specific needs, their health IT infrastructure and its culture. Most enterprise EHR platforms have the technical capacity to do this built in. That’s probably the easier part.

As you can read in the published research on the OpenNotes site, doctors generally adjust well and the disaster scenarios that newbie doctors envision rarely bear out. I know that as my system’s notes open I’ll be dotting the i’s and crossing the t’s with regard to what I write. And despite a little adjustment on my part, that’s a good thing.

If you’re curious about the process of opening notes you’re in luck. The professionals at OpenNotes are making themselves available for basic questions during the month of October. They know a lot about the process of turning on notes. Find ‘em on Twitter with the #opennontes hashtag. Reach out and take advantage of their amazing mindshare.

For those interested, I had a nice conversation with Cait DesRoches, DrPH, executive director of OpenNotes, over in The Exam Room if you are interested. It’s a couple of years old but a great place to get your hands around the open notes movement.

Direct release of health information

The second major element of the law is like open notes but with a bigger short-term impact.

Under the new law it will be required that lab results, pathology reports, imaging studies, operative reports, genetic tests, neonatal screens and more be released immediately to patients. The Cures Rule does allow clinicians and hospitals isolated exceptions around note and information release to account for flexibility, privacy and security. Like when the information in the note could lead to harm (in the case of suspected medical abuse in a child, for example). But exceptions are easier said than done, however. The law is dangerously specific and covers all the creative loopholes you could ever think up.

Right now institutional exceptions are being drafted within health systems around the country. Wanna know how the pros are doing it? Check out CT Lin’s (CIO at University of Colorado) white paper on information blocking. This is an amazing resource.

FWIW, it was suggested this week that the Trump administration may push back the Cures Rule deadlines for healthcare organizations to comply with these regulations for a second time because of COVID-19. I’m gonna guess here that few health systems will be prepared for the November 2nd deadline. But regardless of whether this kicks in November 2 or in the spring of 2021, patients will be getting their results, warts and all, right in their inbox. So stay tuned.

The two absolutes about the Cures Rule

Before jumping in to what we need to do, we have to begin with two absolutes about Cures Rule:

• We can’t change the law.
• We can’t change medical reports.

Actually, we can change the law and medical reports might evolve. But that’s another story and neither will happen anytime soon. So we’re stuck with these two absolute laws about the law. I’ve found that these two absolutes are a great starting point when discussing this with my peers.

What do I think: Transition for patients and doctors

There are going to be some growing pains for doctors and patients.

• Patients. Just like when the internet was new, patients had to figure out how they were going to use web-based information and how that fit in with their relationship with their doctor. Initially patients were punch drunk with what they could do (resulting in what I called the ‘information show of force’ in 1998). But ultimately patients developed what I like to think of as a mature relationship with information. They came to understand the boundaries and limitations of information.
• Doctors. In response to the democratization of information brought by the internet in the 90’s, many doctors thought the sky was going to fall. It didn’t. We all adjusted. And despite the dated advice that we still hear from some late gen doctors don’t look at the internet, most of us have grown up quite comfy working in and around patients with information.

So just like we saw with the internet in the 90’s, the responsibility of adjusting to this law will fall on both parties. Patients will have to understand the vast difference between information and wisdom. And as I like to say, with great access comes great responsibility. This is a huge point since all efforts around this law center on what health systems and doctors need to do – there needs to be a greater effort at educating the public.

But we’ll all grow around the Cures Rule. After a transition, the benefits will outweigh the costs as all of us as patients (we are all patients at some point) earn the access we deserve.

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The Cures Rule: What do we need to do differently?

I’m working this out but here are some early thoughts:

If the research on open notes to date are any indication of acceptance and problems, notes shouldn’t present major surprises in clinics where communication is already solid.

I’m more concerned about labs, studies and other things that go bump in the night. I suspect there will be minor mishaps in the months after the law turns on. But with a little planning this risk can be mitigated. Also, the release of information to patients through portals is already happening – it’s just delayed relative to the finalization of reports and results.

A transition involving education and the management of expectations

Since we can’t change the law and we can’t change doctors reports (here I suggest that physician documentation will change over time), the transition will be about education and managing expectations.

A few things I think we’ll need to get across:

We need to frame the meaning of receiving information. We need to frame the meaning of receiving information for patients. While it’s a patient’s personal information and it’s their right to have it as soon as it is available, they have no responsibility to understand it. But they do bear the weight of handling it responsibly. Again, more needs to be done to facilitate this conversation with the public.

Access does not imply understanding. As part of this information framing process we’ll need patients to understand that there will be limitations to what they can draw from health information. While my patient’s parents can understand way more than I think, we need to lift that weight of responsibility. Like web information, I suspect patients will figure some of this out on their own terms.

The handling of patient information remains personal and individual. The release of studies and notes needs to respect the vast differences in the kind of information patients want and when. Some patients will devour their information while others will be uninterested or will want to be less involved. Neither one is right or wrong. Managing these preferences I suspect will represent a big operational responsibility for health systems.

Access does not change the relationship between clinician and patient. (I suspect it will in the long run, but that’s yet another discussion). We need to emphasize that despite ‘early’ results release, clinicians will always be there to put information into the right context. Hopefully with timely communication from health professionals, the ‘gap’ between receiving information and understanding what it means will be shortened. This will be one huge upside to this mandate.

Preemptive conversations will be key. Workflows and conversations around procedures and studies (especially high impact things like biopsies and imaging) will need to be examined and adjusted in a big way. Preemptively helping patients understand the potential outcomes before a biopsy or MRI will prevent downstream misunderstanding. Disciplines like oncology, genetics, and adolescent medicine will need the most attention in this area.

Reiteration. This transition is not a one and done for health professionals – I expect that this will take months of review, reiteration and correction to achieve the right flows particular to a specialty and its local culture. The federal government in their early enforcement of this mandate would be smart to allow latitude early on as we all figure this out. Early challenges should not be interpreted as a broken concept.

Will there be changes to the marketplace?

How will the marketplace change around the Cures Rule? A couple of ideas…

Tools and collateral information. I suspect we’ll could see the emergence of guides or algorithmic tools for helping patients understand certain studies. This sort of thing has limitations and would only serve as a stop gap until a study can be properly contextualized by a health professional.

Consulting and the Cures Rule market. There is certainly a panel of institutions who have cracked the transparency nut. I might expect some of these organizations to leverage that expertise as the challenges grow for new facilities.

Emergence of new areas of specialization. As physicians throw their hands up around personalized genomics the scope and role for genetic counselors has evolved. In a similar way are there professionals who might make themselves available to mediate information?

Small practices. I haven’t figured out how the Cures Rule will impact small practices and free standing surgical centers that lack the legal and compliance muscle of large systems. My concern is that this mandate will lay bare the challenge of operating as a small free agent in a world with increasingly fluid movement of information. I ran my own own practice in the 90’s when HIPAA dropped and the cost of becoming compliant was substantial.

The Cures Act Final Rule will force us to think about information

So what was once a movement shaped in the spirit of patient empowerment is now an operational reality mandated by law. And just like the early days of the internet, access to personal information will be another element on the tool belt that offers patients a sense of belonging around their care.

The Cures Rule will force health systems to be better stewards of information on behalf of our patients. I think this is going to force health professionals to help patients think about information and what they do with it. It will force patients to recognize the difference between information and knowledge and wisdom. I suspect that the most critical ultimate change will be transparent conversations and more timely physician follow-up on high stakes studies.

More on this as the story evolves. And I’d love to know what you think.

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And as a reminder, this letter is not legal advice. Consult with your local compliance and legal consul to figure out how local laws may apply to your situation.