New federal rules around data-sharing aim to give patients unprecedented access to their healthcare information much the way they already manage their finances or travel information.
A rule from the Office of the National Coordinator for Health IT (ONC) will require patients are able to access their health information and share it with third-party apps.
"A core part of the rule is patients’ control of their electronic health information which will drive a growing patient-facing healthcare IT economy, and allow apps to provide patient-specific price and product transparency," said Donald Rucker, M.D., National Coordinator for Health Information Technology, during a call with reporters.
Under the rule, hospitals and doctors are required to provide software access points, or endpoints, to their EHR databases so that patients can download these records to their smartphones. The rule also aims to penalize information blocking, or anti-competitive behavior that hinders the exchange of medical information.
Those are just a few major changes included in 1,244-page rule released Monday that will have huge implications for providers, health IT vendors and health information exchanges.
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While there likely won't be an immediate impact in the industry, the regulations could shake up the healthcare market in the long-term, stakeholders say. "These rules plant patients at the center of healthcare delivery to give them control of their data and enable them to direct it to whoever they want. That’s a reality now under these rules," said Jeff Coughlin, senior director of federal and state affairs at the Health Information Management and Systems Society (HIMSS).
Here's a look at major changes industry stakeholders can expect.
1. Health data will be easier to access
Patients will now be able to securely and easily obtain and use their electronic health information from their provider’s medical record for free, using the smartphone app of their choice, according to ONC.
As a condition of health IT certification, electronic health record (EHR) vendors will have to enable the export of electronic health information (EHI) for a single patient's data.
This means that a patient would be able to download all the health information that a hospital has in their medical record, not just what is in the patient portal, according to Jeff Smith, vice president of public policy at the American Medical Informatics Association (AMIA).
Under the rule, EHR vendors also will have to enable an export all of the patient records when a health care provider is switching health IT systems.
"Right now, when a provider switches EHR vendors, the vendor is only required to provide the summary of care records. This new requirement will potentially create the ability for providers to switch EHR vendors more easily and more completely," Smith said.
EHR companies have 36 months to comply with that requirement.
2. Information blocking will be prohibited
The rule seeks to prevent information blocking practices by healthcare providers, vendors, health information exchanges, and health information networks. That provision goes into effect in six months.
ONC established eight "exceptions" to the information blocking ban to allow clinicians and hospitals "common-sense operational flexibility," including protecting patient privacy and security as well as handling situations where moving data is technically infeasible.
Providers will not violate the information blocking rule if they try to educate patients about the privacy and security risks posed by the apps they want to use, ONC leaders said.
3. The information blocking ban lacks teeth, for now
The ONC rule doesn't include enforcement in the form of civil monetary penalties for information blockers.
Steven Posnack, Deputy National Coordinator for Health IT, said ONC was working with the HHS Office of the Inspector General on new regulations to establish civil monetary penalties. That rule will be coming out soon, he said.
"I hope we do some strong enforcement on this. That will send a strong message to the industry, and I think the industry will be looking for that," said Matt Michela, CEO of Life Image, a network for managing medical information.
"It will be easy for large organizations to drag their feet and slow this up," he said.
4. No more "gag clause" on EHR screenshots
As a big win for researchers and doctors, health IT vendors are now prohibited from restricting the sharing of screenshots and videos of their screens.
Researchers and doctors have long advocated for sharing screenshots of EHRs as crucial to improving usability and safety problems.
Currently, many EHR contracts contain non-disclosure provisions that either prevent or are perceived to prevent users from sharing information related to the EHRs, such as screenshots or video, and having an open discussion about problems, according to ONC.
Many EHR executives, including Epic CEO Judy Faulkner, had protested that provision in the proposed rule, saying it threatens companies' intellectual property.
The new rule allows sharing screenshots but limits the screenshots or videos to only the information that’s necessary to communicate a health IT-related need.
5. Potential EHR market disruptions
Digital health, telehealth and Internet of Things (IoT) companies stand to benefit the most, as do insurance companies, according to Cowen investment analysts in a research note.
Digital health companies will get better access to data, which has been a barrier, and payors will see improvements in care management, the analysts wrote.
The new rules will result in near-term headwinds for EHR vendors and hospitals. The time frame to comply will require additional spending on the EHR vendor’s part. Health systems also face upfront implementation costs, Cowen analysts said.
In all, despite some near-term headwinds for certain players, Cowen analysts believe interoperability "can unlock much more value for the entire healthcare system."
Many stakeholders believe the rules will significantly disrupt the EHR market.
Michela predicts that large healthcare companies that have been "slow-walking" interoperability are at risk to not survive.
"There will be new market entrants, once these APIs are created and it will create fundamentally new models that threaten very large established companies in the space. It will be interesting to see, in the next three to five years, how many companies will be disrupted that didn’t embrace interoperability, or minimally embraced it," he said.
6. The move to an app economy will drive a bigger focus on privacy
Many stakeholders believe the rules will be a boon for Silicon Valley technology companies, who are already making inroads in healthcare, as well as digital health companies. This will help to spur more innovation in healthcare, stakeholders say.
But third-party apps will not be required to follow data blocking policies under ONC's rule and are not covered under HIPAA. This raises serious privacy concerns about patients' medical data and the potential misuse of data.
Former health IT policy leader Lori Evans Bernstein anticipates new privacy laws will take shape to fill in the gaps.
"Ultimately there will be a real update to HIPAA, and that will require Congressional action," said Bernstein, who is the co-founder and chief operating officer of HealthReveal.