Wednesday, August 01, 2012

Disruptive Innovation in Health IT: A Path to Acceptance (Part 2)

In my previous post, I defined what disruptive innovation is and why it's important to healthcare transformation. I will now discuss my experiences over the past year with attempting to introduce a disruptive health IT innovation to the Federal  Government.

I was delighted when I first found out that the Obama Administration was making good on its promise to increase transparency into the inner working of our gov't by opening to the pulic several programs administered by the National Coordinator of Health IT (ONC). ONC was looking for volunteers to join workgroups aimed at developing rules and regulations for the exchange and use of protected health information (PHI). Input from innovators was encourged time and time again as evidenced by the Fed's Care Innovation Summits, Meaningful Use and Health Care Innovations ConferenceDigital Government Strategy, "open government" initiative to drive rapid innovation, and more. Government transparency and support for true innovation aimed at improving patient care. WOW...Love it!!!

I found out about two such programs last year and jumped in with both feet. One is the Direct Project, which is focused on using secure e-mail to exchange PHI. The other is the Standards & Interoperability (
S&I) Framework, which is focused on "enabling harmonized interoperability specifications to support national health outcomes and healthcare priorities, including Meaningful Use and the ongoing efforts to create better care, better population health and cost reduction through delivery improvements." Each of these programs has various communities of volunteers who collaborated in many different workgroups and sub-workgroups. They establish use cases, standards, specifications, and reference implementations based on the specification; they also run pilot studies. I personally spent most of my time focused on sharing my knowledge, skills and novel technology with the Direct Project and the S&I Framework's Query Health Technical workgroup.

Although I've met some fine people during these meetings and gained useful knowledge, I've been frustrated by the programs' decision-making process, ever-growing complexity, closed social networks, and fear of disruptive innovation. The following situation exemplifies some of my concerns.

An article in InformationWeek last month, titled “ONC Releases Guidelines for Direct Clinical Messaging,” discussed some state-contracted health information service providers (HISPs) make secret deals to create and control data silos in an attempt to block competition within the Direct Project. These tactics not only stifle innovation and choice, but they also defeat the purpose of the program.

To me, the most troubling thing is that these anti-competitive (restraint of trade) and innovation-busting practices have been condoned by gov’t officials! Let me explain …

According to the article (bold added for impact):

ONC has issued guidelines for the more than 40 statewide health information exchanges (HIEs) that have launched or are starting services that use the Direct Project secure messaging protocol.
The guidelines are designed to ensure that state-contracted health information service providers (HISPs)--private companies that route Direct messages between providers or between providers and patients--allow information to flow within and across states. The ONC document also spells out how HISPs should comply with the Direct protocol and accompanying policies for trusted, secure data exchange.
[However, no rules exist] for sending messages [between people using]…different HISPs…some HISPs have [thus] started making one-on-one agreements with other HISPs to exchange Direct messages [even though] ONC says that ‘such peer-to-peer legal agreements are expensive and time-consuming to implement and are cumbersome to monitor and enforce. They are not a long-term basis for scalable trust.’
…[Nevertheless, some] HISPs will continue to make side agreements with one another—and [Erica] Galvez [community of practice director in ONC's state HIE programs] sees nothing wrong with that. If the HISPs comply with guidelines and the applicability statement, and consider themselves business associates…they certainly could enter into one-off agreements. If they do, I'd hope that they'd use these guidelines as the basis for that so they have a consistent, level playing field across HISPs.’
The ultimate goal of Direct, according to Galvez, is to provide a national standard for clinical messaging so that providers can easily push messages and attachments to each other and to patients. To the extent that HISPs create their own information silos, she noted, they defeat the purpose of the program.
In addition, a blog post by John Moehrke at this link quotes an ONC release sent to the HIE grantees:
ONC has found that many...HISPs...are deploying Direct in a way that proactively enables exchange within a given HISP’s boundaries while not offering mechanisms or supporting policies that enable exchange with other HISPs. Such limitations effectively block providers using different HISPs from exchanging patient information. In effect, HISPs are creating 'islands of automation using a common standard.'  
John then goes on to say that the release states that HISPs "should" do things differently, but criticizes ONC for failing to state that they "must" change their ways.

This whole thing bothers me! Here are my questions/issues:

WHY is it OK for HISPs to defeat the purpose/goal of the Direct Project, regardless of whether they "...comply with guidelines and the applicability statement, and consider themselves business associates"?

Shouldn't the guidelines and statements be changed to assure the purpose of Direct is upheld in light of this troubling issue?

More in my next post.
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