Legislating health IT Interoperability?

ICYMI, a bill was introduced last week from the office of Representative Burgess (R – TX).  Here’s a link to the pdf of the bill.  It’s clearly just an early version – with many gaps and many invitations for enhancement, but it’s an important lens on how Congress views the  opportunities ahead for health IT.

If we view this in the context of the five Senators’ blog post last week in Health Affairs, we can surmise a few things:

a) Congress understands that health IT is complicated.

b) Congress understands that the majority of hospitals and care providers have adopted health IT.  This is, as they say, a “good problem to have.”

c) Since the systems have been adopted, it has become clear that causing them to interoperate seamlessly is much more difficult than many people expected.

Let’s parse the Burgess bill first.

a) The bill attempts to redefine interoperability as:

“open access”

“complete access”

and

“does not block access.”

b) The bill proposes to disband the Health It Policy Committee and the Health IT Standards Committee and create a new FACA – with its membership entirely managed by Congress – guide HHS on the definition of interoperable health IT systems.

c) The bill proposes to impose penalties on those who fail to comply with the definition, and requires providers and hospitals to attest that they do not block interoperability.

d) There is no mention of other capabilities or standards to which systems would be held, but the Secretary would, it seems, be able to define them.

a) Unfortunately, “access” and “interoperability” are different concepts.  There is already a very good definition of interoperability that has been adopted beyond health care:  the Institute of Electrical and Electronic Engineers (IEEE) provides the generally accepted definition of interoperability, at least from a technical perspective. It defines the term as “the ability of two or more systems or components to exchange information and to use the information that has been exchanged.” See IEEE Standard Computer Dictionary: A Compilation of IEEE Standard Computer Glossaries (New York, NY: 1990).  (My emphasis on “exchange” and “use” added above.)

HHS has adopted this definition – as has (with some modification) the FCC.

But let’s look past this to see if we can understand what Representative Burgess was aiming for – and see if we can help address the problem he’s aiming for.  The problem he’s trying to solve is real: we buy health IT systems and then they don’t just talk to each other!  Why didn’t this “meaningful use” thing make them work like that?

Good question.  $30B later – the systems don’t talk to each other easily.  They’re not “plug and play” and we expected that they would be.  Is it because there wasn’t a good enough definition of “interoperable?”  IF we somehow mandate “access” in all forms, will this solve the problem?

No.

You can access your bank account – but that’s not because it’s interoperable.  That’s because the bank made it accessible.  You can withdraw money from an ATM because your bank (and your money) is interoperable.  You can exchange and use your information in the bank.  It is also (we hope) manage there in a form that is safe and secure.  The technical standards that banks and others in the finance industry use are well defined, and while this is complex in finance – it is hundreds-fold more complex in health care.  Finance moves information that is – in various forms – multiples or fractions of a penny.  Health IT systems move information that is much less clearly expressed.   ONC’s interoperability roadmap is a good start, but as the Five Senators wrote in their blog post – it lacks the specificity that we now need to move ahead.  One could of course argue that a roadmap isn’t the place for specificity.  The regulations are where specificity will be found, and these are likely to be released in proposed form in the coming weeks.

b) The existing FACAs could be better – but they don’t need to be ripped out and replaced.  The HITPC and the HITSC should be better coordinated with NCVHS, as the bill implies.  ONC’s management of these FACAs has been a bright spot: they are very transparent, open, collaborative and engaging.  I’d suggest that Congress needs to pay more attention to the very frequent meetings convened by these FACAs so that they can better understand the great value that they add.

c) Penalties for health IT systems that are not compliant with interoperability expectations does make sense.  But we had better be sure that the definitions are clear and flexible.  I don’t expect that Representative Burgess wants to curtail innovation, but that is exactly what will happen if there is a strict regulatory framework imposed on a definition of interoperability that holds civil penalties above it like a guillotine.   Consider that the MOST interoperable/safe/secure form of money is probably bitcoin.  Bitcoin can – by definition – be exchanged and used.  Indeed – these two verbs are buried deeply in the DNA of bitcoin.  Yet the standard tools that are used to exchange pennies and dollars are not used (or even necessary) to store, exchange and use bitcoin.  So a definition of an interoperable money exchange system would not likely be met by bitcoin.  A banking system that offered consumers a method of banking bitcoin certainly would lack some of the security safeguards that other systems have – but this is because the security safeguards necessary for traditional banking systems aren’t at all necessary for bitcoin banking – since bitcoin is fundamentally more secure.

So if innovators in 2021 dream up incredible methods of (safely, securely, privately) exchanging and using health information, we would want the regulations to anticipate and allow for such creativity and not stifle it.

While Rep. Burgess’ bill offers that the Secretary would have the freedom to modify the suggestions of the