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The comment period is over. ONC and CMS will now have to wade through stakeholder feedback on the proposed information blocking and interoperability rules before they move forward.
Here is a roundup of voices from healthcare leaders on the proposed rules. They include a combination of informal feedback from healthcare leaders and summarized, formal comments from several former national health IT coordinators, as well as the American Medical Informatics Association.
The proposed rules lay the groundwork for interoperability in healthcare, but some experts also provided input on areas that still need to be addressed for improved data sharing between healthcare organizations, providers and patients to become reality.
The importance of addressing data sharing, information blocking
John Halamka, M.D., CIO, Beth Israel Deaconess Medical Center, said:
"You always have to read these regulations in the context of what will be the compromise that comes out of this, either in scope or timing. When I read them, I thought it's exactly the right tone. What I mean by that is it was not too little, not too much, you know there will be some compromises. It seemed to hit that sweet spot.
"Information blocking, for example, is, at least in my mind, a kind of controversial concept. I have in my various roles rarely seen volitional information blocking. What I've seen is people have different priorities, budget constraints; they've got a thousand competing initiatives. It's not so much mean spirited. When you look at the way this is written ... this is very real world in the way it's written.
"What's going to happen as these become finalized rules, you're going to see not only Apple, but you have to guess Google and Amazon and all these other organizations putting APIs [application programming interfaces] in products and services. It will have a very, very significant impact, I believe.
"One last thing I would say is you know that HIPAA and the general data protection rules both have fines associated with them for privacy breaches. But if you give the data to the patient and the patient shares it as they will, neither HIPAA nor GDPR apply. That's why I think these regulations are a great way to get started because, in many ways, it de-risks a lot of data sharing. Giving data to the patients, getting everybody comfortable with more data flows and changing culture is a fine way to change management."
Laura Esserman, M.D., director of the UCSF Breast Care Center, said:
"The importance of these rules is that if you have information that's related to patient care and a patient wants it or requests it you have to give it to them. If you are making an app to help facilitate getting that information, that can't be blocked either. I think that is really critical, that's an incredibly important first step. And if you block it, there's a penalty. I think the enforcement of these rules is going to matter.
"Everyone wants to delay this. The CIOs want to delay it. But it's ridiculous. Let's get over it. Everybody understands this has to be changed. People can't get the information that they need, but I think the importance of these rules is there is a statement that interoperability is important, that data exchange is important."
"Through apps, there has to be not only read but write. Physicians and clinicians, providers, will use those apps, but they need to know that can be put back into the EHR and that's their note. They're not going to do it twice, and why should they? We have to make sure we don't crush innovation here, that's the next step; [it] is to be able to have these layers of quality improvement on top of these systems."
"These rules are a fantastic start ... we have been waiting for these rules, but I don't think they go far enough. EHRs have not delivered on their promise of improving safety. Asking a patient 20 times what their allergies are, what their name is, and medical record number, they don't perceive that as quality. What we want to do is build quality systems. In order to have that kind of a system we have to have write-back. They have not specified the write-back rules and what the write-back rules should be if you are a certified, one-source checklist that meets X standard, that data should be allowed to be written back to the EHR and that should be allowed to be exchanged with any other provider because it's against a national standard."
Stakeholders submit written comments to ONC, CMS
Former national health IT coordinators: David Blumenthal, M.D., David Brailer, M.D., Karen DeSalvo, M.D., Robert Kolodner, M.D., Farzad Mostashari, M.D., Vindell Washington, M.D.
The group of former national health IT coordinators offered their "enthusiastic support" for the proposed rules in a letter submitted to ONC and CMS. They noted that the rules coupled with the Trusted Exchange Framework and Common Agreement (TEFCA) Draft 2 offer an opportunity to advance interoperability and empower patients with access to their data.
The letter noted the promise of APIs, describing APIs as transformative in other industries and as a disrupter in the healthcare space, enabling easy data access for patients. The group also offered strong support for requiring the implementation of Health Level Seven Fast Healthcare Interoperability Resources (FHIR) as the standard for open APIs.
"We believe the use of FHIR-based APIs to make patient claims and other health information available to patients and payer participation in trusted exchange networks will result in the creation of a more complete and longitudinal picture of a person's healthcare history and represents a huge step forward," according to the letter.
The letter states that the group of former national health IT coordinators believes it is of the "utmost importance" to implement the proposed rules as quickly as possible. But it also noted the rules do not adequately address patient and consumer privacy protections. The group recommended that CMS and ONC work with relevant agencies and organizations to develop a privacy framework in parallel with implementation of the proposed interoperability rules to protect consumers.
The group also suggested ONC and CMS invest in efforts to educate a wide range of stakeholders, including payers, patients, providers and health IT firms so that they understand the implications and opportunities of the proposed rules.
American Medical Informatics Association
Douglas Fridsma, president and CEO, AMIA; Peter Embi, AMIA board chair
In its letter to ONC and CMS, the American Medical Informatics Association applauded the proposed information blocking and interoperability rules and ONC and CMS on its translation of the 21st Century Cures Act.
AMIA stated that it supports many of the proposals made in the rules and noted that the reliance on FHIR data standards will help move healthcare away from systems that operate in silos and toward interoperability based on open APIs.
The letter also cautioned ONC against taking an approach that solidifies the need for health data to be standardized before it can be made available for patient care or research. Instead, AMIA recommended that ONC establish a "share now, standardize as needed" policy.
The current Notice of Proposed Rulemaking (NPRM) "perpetuates an imbalance where patients, clinicians, and researchers are beholden to health IT developers for routine access, exchange, and use of health data," according to the letter. If finalized as the proposed rules are now, AMIA believes they will create a dynamic where health data must be standardized before it is made available for patient care or research.
"While the informatics community fiercely advocates for the standardization of biomedical, clinical and health data, AMIA flatly rejects a policy that requires data to be standard before it can be used for patient care," according to the letter.