Do we need more or less healthcare IT regulation and legislation?

'Sometimes when clinicians prescribe medication, although it does therapeutic good, it creates side effects which need to be addressed by changing a dose or by adding additional medications.'
By John Halamka, MD
11:48 AM
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Just as I clarified last week in my post about certification, the answer to the question "do we need more or less healthcare IT regulation and legislation" is that we need the right amount of the right regulation/legislation.

Sometimes when clinicians prescribe medication, although it does therapeutic good, it creates side effects which need to be addressed by changing a dose or by adding additional medications.

Such is the case with HITECH. It was generally good medicine, but now that we’ve seen the side effects on workflow, clinician burden and efficiency, there needs to be a dose adjustment.

I was recently asked to review the "Improving Health Information Technology Act" introduced by Senator Lamar Alexander, R-Tennessee, in February 2016 and placed on the Senate Legislative Calendar in April 2016. Its intent is good – to refine existing healthcare IT legislation with fixes that enable the right amount of the right regulation.

You’ll find the summary here and the full text of the bill here.

Here's my analysis, section by section:

"1)  Assisting Doctors and Hospitals in Improving Quality of Care for Patients

Reduces documentation burdens by convening public and private stakeholders to develop goals, a strategy, and recommendations to minimize the documentation burden on providers while maintaining quality."

This is a good thing. It fixes the language in HITECH which required each stage of Meaningful Use to be more stringent than the last.  That language required regulators to make each update to Meaningful Use more challenging.The Improving Health Information Technology Act enables regulators to better balance benefit and burden.

"Allows and encourages health professionals to practice at the top of their license, allowing non-physician members of the care team to document on behalf of physicians."

This is a good thing. It encourages more team based care and documentation. Using electronic systems effectively is a team sport and should leverage social networking/groupware ideas to capture electronic data.

"Encourages the certification of health information technology for specialty providers and sites of service, like pediatric care, where more specialized technology is needed."

As long as the Certification focuses on a few key important ideas, as noted in my previous post, this is a good thing.One set of required functionality does not make sense for diverse software supporting specific specialties.

"2) Transparent Ratings on Usability and Security to Transform Information Technology (TRUST IT)

Establishes an unbiased rating system for HIT products to help providers better choose HIT products."

A government program to do this is unnecessary.The private sector has KLAS and other companies providing such information already.

"Allows HIT users to share feedback on the user experience of specific HIT products related to security, usability, and interoperability, among other concerns."

A government program to do this is unnecessary. The private sector has KLAS and other companies providing such aggregations already

"3) Information Blocking
a. Gives the Department of Health and Human Services (HHS) Office of the Inspector General the authority to investigate and establish deterrents to information blocking practices that interfere with appropriate sharing of electronic health information"

Although I have not personally experienced information blocking, I hear anecdotally that there are some places in the US where competing systems refuse to share data with each other. Giving the OIG the ability to investigate is reasonable.It’s not clear there will be much to investigate.

"4) Interoperability

Convenes existing data sharing networks to develop a voluntary model framework and common agreement for the secure exchange of health information across existing networks to help foster bridging between networks."

Convening stakeholders to develop a voluntary framework is reasonable. However, I believe the private sector will do this on its own in 2016.

"Creates a digital provider directory to both facilitate exchange and allow users to verify the correct recipient."

This is a good thing. CMS could leverage the existing national provider identifier system.

"Requires that HHS give deference to standards developed in the private sector."

This is a good thing. The private sector is moving very fast to embrace simpler standards such as FHIR.

"5)  Leveraging Health Information Technology to Improve Patient Care

Requires that certified HIT exchange data with registries if registries are certified to use standards endorsed by the Office of the National Coordinator (ONC)."

There are no mature/adopted standards for registry exchange at this time. In the interest of comprehensiveness, ONC has tended to publish/endorse standards that are not yet ready for adoption. Registry participation should be left to the marketplace.

"Includes vendors in Patient Safety Organizations to allow for improvements in the safety and effectiveness of HIT."

This is very reasonable

"6) Empowering Patients and Improving Patient Access to Their Electronic Health Information
a. Supports the certification and development of patient-centered health record technology so that patients can access their health information through secure and user-friendly software that may update automatically."

Although patient and family engagement is very important, it is not something that the government should certify.Apple and other consumer companies are innovating at the speed of the market, taking us in new directions that government could not have predicted.

"Encourages the use of Health Information Exchanges to promote patient access by educating providers and clarifying misunderstandings."

Health information exchanges really do not have a role in patient/family engagement.The new approaches implemented by Apple  and other innovators directly connect the patient and provider.

"Requires HHS to clarify situations where it is permissible for providers to share patient information by providing best practices and common cases where sharing is allowed."

Clarifying HIPAA through education is a good thing.

"7) GAO Study on Patient Matching
a. Directs the Governmental Accountability Office (GAO) to conduct a study to review methods for securely matching patient records to the correct patient. "

This is a good thing. We are not going to be able to consolidate records across the care continuum unless we can identify the patient.

There you have it – a dose adjustment for HITECH. Dose adjustments can have their own side effects. Hopefully the bill will be adjusted as suggested above before it is passed. The goal of any new legislation/regulation, just as with medical care itself, should be to first do no harm.

This blog post first appeared on Life as a Healthcare CIO.