Chilmark has not put up a post in a few days due to the death of the brother of a very dear and close friend.  Her brother passed away in a late night car accident.  He was 21 years old. He was alone.

Sad and confusing.

So sad for no parent should have to bury their child.

So confusing as this is a wonderful family. The parents who were medical professionals immigrating to this country from the Dominican Republic some two decades ago, raising their only son and only daughter here.  Now they are left with just one child – tragic.  What reason is there for them to suffer so?

The wake was yesterday, the funeral today, support to the family continuous.

Have many topics to cover, much to write, but it may be another day before something shows up.

Trust you understand and will bear with us.  By next week, we ought to be on a more normal schedule.

Until then, treasure what you have, be they parents, children or close friends for this life is precious and fleeting.

On the eve of our nation’s Independence Day, it is a good time to reflect on what this truly means to us, the US citizen and even reflect upon what this means within the context of healthcare and future reform efforts.

From the beginning, the writings of Chilmark Research have tried to steer clear of broad healthcare policy discussions. Lord knows there are more than enough Blogs and posts addressing that subject.  But healthcare is, by its very nature, directed by policy at all levels and one can not look at issues in the HIT market without some reflection on the policies in place or being developed that may drive technology adoption and use or hinder it.

Originally, we also intended Chilmark Research to focus on consumer-facing technology, but how naive we were to think that we could look at only these applications without considering their context, use and ultimately, the data they would gather and present to help a consumer better manage their health.  Thus, applications such as EMRs, or the new buzzword, “certified EHRs” which create some of the richest and most useful health data as well as future exchange architectures/platforms (NHIN, RHIOs, HIEs) have fallen into our area of coverage.  In doing so, however, we always keep the thought in the back of our minds: How will this technology, how will its use be reflected within future consumer applications?

Now within the context of healthcare is a smoldering issue that could ignite into a firestorm, the issue: health data access and ownership.  A little over a week ago we did a post of the Health Data Rights declaration, a simple declaration stating  the consumer has basic rights to their health data.  Chilmark Research, along with some 950 others, endorsed this declaration and encourage you to do so as well.

Honestly, the declaration is not that revolutionary as it simply restates rights already supported by HIPAA in simpler, more understandable terms. What is surprising though is the lack of endorsements by providers and payers of this simple declaration, which is it not fundamental to our rights as individuals?  After all, is not personal health information (PHI), be it claims, lab data, medication data (PBM data), images, and other clinical information not ours? Does it not fundamentally belong to those for which it is about?  Is it not an individual we are talking about and without that individual, this data would not exist?

This is the smoldering issue underlying basic questions such as:

• Who ultimately has access and control of the data?
• Who decides who sees the data?
• Who has the right to add notes to a record, to suggest corrections?

These are critical questions that require thoughtful, meaningful discussions among all stakeholders to address fears, and concerns. But let us not needlessly bog-down (this industry sector seems famous for that) in meetings that go in circles. Reach a level of consensus and move ahead.

When we celebrate the brilliance of our founding fathers tomorrow, the Declaration of Independence and Bill of Rights they created which have held up so well for these 200+ years, let us also begin reflecting on a citizen’s right to their personal health information. No longer should a consumer be held hostage, it is time to storm the barriers and take personal control of one’s most personal details, their PHI.

The feds are beating the CONNECT drum. This week, ONC sponsored a two-day event in DC to begin educating the market as to what CONNECT is and how it may be leveraged to support information exchange.  At least that is the impression one had in signing up for this event.  In actuality, the event was somewhat schizophrenic in gyrating back and forth between the National Health Information Network (NHIN) and CONNECT, the software platform upon which the National Health Information Exchange (NHIE) and intra-agency network.

In terms of attendance, probably close to 700, with a huge contingent of consultants (beltway bandits) such as Harris, Northrup, MITRE, IBM, SAIC and of course Sun (soon to be Oracle).  Event also attracted high level visibility with ONC head David Blumenthal kicking off the event, followed by Obama’s new CTO, Aneesh Chopra.  (Note, for all of you developers out there, Aneesh talked about government transparency and the new data.gov site. Though in its infancy, released just over a month ago, data.gov may provide some interesting mash-up opportunities but unfortunately lacking healthcare data.)

So what is CONNECT?

In simplest terms, CONNECT is a technology stack built with Open Source software (Sun-derived) to support the development of the NHIE and more broadly a NHIN.  Thus, from the onset CONNECT has had broad participation from the likes of CMS, the VA, DoD, Bureau of Indian Affairs and the first true test case user, the Social Security Administration (SSA) who recently completed a successful beta test of the platform with RHIO MedVirginia.  In March 2009, V1.0 of CONNECT was released to the market.  On July 9th, V2.1 will be released.  While CONNECT was developed to create an NHIE, it longer-term goals are to become the backbone to the NHN.

CONNECT was built on Open Standards, mostly the Sun open source stack.  The underlying database today is Sun Solaris, on top which sits a common 3-tiered architecture built with Java tools.  Directly above the database is the secure, NHIN messaging layer for secure transport.  A Services layer for query, search, patient identification and exchange sits above messaging. The final layer is the “Profile” layer for specific domain functionality and the building of novel apps such as those for biosurveillance, population health, quality reporting, etc.

In building the core CONNECT platform, developers paid special attention to keeping functionality to a minimum to insure flexibility and enable innovation as the NHIN gains traction.  Naturally, Web Services are supported within the context of CONNECT’s core SOA.  For the consumer preference profile, CONNECT developers adopted the OASIS standard, XACML.  The CONNECT services directory uses UDDI V3.0.

And Current Thinking on the NHIN?

John Glaser, who was also on the agenda listed five key activities of the NHIN development:

1. Create and demonstrate a series of standards and protocols for defining data exchange at State & National level.
2. Establish DURSA (Data Use & Reciprocal Support Agreement) & legal agreements for data exchange.
3. Establish governance mechanism to set path for future development direction of the Open platform.
4. Conduct a series of demos to test functionality, usability and value.
5. Promote development of “interstitial technology” for NHIN platform to make it actually functional and useful (e.g. patient identifier).

And in grand style, Glaser went on to conclude that the NHIN sets the “framework, the structure and foundation” for broader future exchange in support of “meaningful use.”  In fact, throughout the first day numerous speakers would keep circling back to meaningful use, the HITECH ACT, ARRA etc. and how CONNECT fits in.  Many of these connections between CONNECT and ARRA legislative language were quite a stretch of the imagination making one wonder why the need for such over-reaching justification? Does CONNECT really need to be so heavily pitched to the market to justify its existence and promote its adoption?

Business Model Anyone?

Maybe one of the biggest red flags was a complete lack of discussion over the course of this two-day event on viable business models for Exchanges, a notorious issue that most public-sponsored Exchanges has struggled to address. That’s not to say the money is not there, it just seems as though the policy wonks in DC and the multitude of beltway bandit contractors that the feds (HHS) hires just don’t think about this issue, or just do not know how to address it.

For example, currently, the SSA spends $500M/year (yes a half billion dollars a year folks) on converting medical records to a digital format, and that has nothing to do with the huge back-load of disability claims that SSA is trying to address which has its own hidden costs to both providers and the SSA.  Now there is a business here, we’re sure of it and CONNECT might play an important role if one were to develop a novel “interstitial app” on the platform that would facilitate the SSA in addressing this problem.

Addressing Data Ownership: The Bane of Most Exchanges

In Chilmark’s past research on Exchanges, beyond establishing a viable business model, data ownership within the Exchange is an extremely difficult challenge where it appears only the lawyers come out ahead.  For the CONNECT NHIN, the initial consortium has drafted a DURSA that addresses virtually all aspects of data exchange and use, from consent, to obligations to permitted purposes for using data and ultimately data ownership.  The DURSA is currently undergoing internal agency review and likely to be released by end of year.

Key components of the DURSA include:

• Extension of HIPAA to all participants on the NHIN.
• HIPAA is the floor for all activities on NHIN but local and State laws that go beyond HIPAA are not preempted.
• Limited permitted uses of data (e.g., neither use for research or legal/enforcement is allowed).
• All participants must respond to a data request from an NHIN member. One is not required to share data, but must, at a minimum, acknowledge request for data.
• Once data is transferred to recipient, data is now owned by recipient and they can share/exchange data anyway they see fit that is in conformance to their policies.

Clearly, the fed consortium that put together this DURSA is looking to maximize data liquidity.  Despite their good intentions, it is unlikely that this will be readily adopted in the market for despite assurances, risks to the consumer, the patient appear greater than the value derived.  In speaking with one doctor after the DURSA session, he just shook his head saying that very few practicing physicians that he knows would accept these DURSA terms.

Where is the Consumer Voice in All of This?

One the morning of the first day, Sarah Wade, the wife of a retired soldier wounded in Iraq spoke to the challenges of caring for her husband in this convoluted healthcare system that we all, as citizens, must contend with.  Her talk was real, it was heartfelt and something that many of us can relate to within some aspect of our own lives.  Yes, the secure exchange and sharing of personal health information (PHI) has far more benefits than many of the purported risks.  But that does not mean that citizens do not have a voice in these discussions as ultimately, these discussions involve the most personal aspects of their lives, their PHI.

Unfortunately, there seems to be little here within the hallowed walls of those developing the NHIN that pertains to the US citizen.  Yes, they have insured that at a minimum, HIPAA is there to protect PHI, and yes, there are provisions to gain consent for exchange of PHI among certain participant types and maybe most importantly, one of the six permitted data uses is allowing the consumer to request that their data be exported to a PHR – all well and good, but simply not enough.

First, when data is exchanged on the NHIN there is no capability to discretely tag data to share only that data which is pertinent to specific care and treatment.  A spokesperson stated that data tagging was simply too complicated an issue to address, thus taken off the table.  Weak excuse – Microsoft HealthVault has that capability today.

When asked about the role of consumer data ownership and the PHR within the context of the NHIN, ONC stated that they have had internal discussions, yet have reached no conclusions, apparently, no clear policies.  For now, it looks like they have put this on the far back-burner.

As mentioned previously, the DURSA allows for the transmittal of PHI from one participant to another and once the requester receives the data, the requester becomes the data owner as well and may share/distribute the data in anyway they desire in accordance with their own policies and guidelines.  Big question here is how will the NHIN provide a citizen with a clear audit trail of all who have viewed their PHI? No answer to date.

Based on what was presented this week, it appears that these critical issues were by and large side-stepped as the agenda for CONNECT and NHIN is all about the enterprise, be it a government agency or a hospital.  Certainly understandable that someone like the SSA would have such a view but it is unfortunate that HHS/ONC has not been more inclusive of the citizen in its deliberations and development of core policies.

Looking Ahead

At first blush, Chilmark saw CONNECT competing with existing Exchange vendors such as Axolotl, InterSystems, Medicity and Wellogic. Conversations with a couple of these vendors, however, gave a different view – they see little threat today. CONNECT is simply too immature and despite it being open source, an adopted will still need a full team to configure and implement the solution and support it, no small task.  As one vendor told me: “…technology is only 20% of the problem in setting up an Exchange.” For the foreseeable future, it is unlikely that CONNECT will impact these vendors.  Of course, a large service provider with a strong healthcare IT practice (e.g., CSC, IBM, Perot, etc.) could make a play here successfully leveraging CONNECT into a full-service offering competing directly with these vendors. Yet even this scenario is still a few years out due to CONNECT’s immaturity as a full-fledge Exchange platform.

Where CONNECT will see the greatest traction is within the federal and possibily state governments that are looking to take waste out of the system, such as the SSA example cited previously.  In that context we will see service providers capitalize on this service opportunity to government agencies.  We will also see vendors create CONNECT gateways allowing others outside of government to participate in the NHIN in support of anything from meaningful use (quality reporting and information exchange) to facilitating care transition (military to private practice – RelayHealth did a nice demo of this), to supporting transactional processes.

But CONNECT and the NHIN have a long road ahead of them.  For CONNECT it will be about the creation of a community of developers that look to build apps and ultimately businesses that leverage the core technology stack that is CONNECT.  Unfortunately, at this event organizers did not have anyone address the business opportunity of building for CONNECT.  Without that ecosystem of apps, CONNECT may ultimately fade into a small, relatively irrelevant platform.

On the NHIN-side, it is hard to see a massive groundswell of support. Within the context of the NHIE, yes there is value, but when one extends the model beyond those confines it becomes increasingly difficult to define a sustainable model and some of the DURSA language will be met with strong resistance outside the cloistered government view.

In addition to sustainability, there are some serious issues regarding citizens’ PHI rights to control the sharing of their data.  Without clearer, more defensible answers to some of the questions outlined above regarding PHI, NHIN could face some siginifcant hurdles on the public stage.  HHS leadership would be wise to go back and rethink their strategy to engage citizens in promoting NHIN beginning with giving the citizens a greater say in just how there PHI will be shared and used. Ultimately, HHS/ONC is going to need that strong citizen support to induce change in the healthcare sector, including adoption and use of the NHIN.

In the FWIW column, Chilmark Research submitted its comments on the Draft Recommendations for Meaningful Use, whic were released on June 16th.  Today at 5pm was the deadline and we barely made it (email time-stamp of 4:59pm).  Following is the text of the email/comments we submitted to HHS and we certainly welcome your feedback, e.g. we are totally nuts, reasonable or wimped out and did not push hard enough?  Also, we purposely did not try to cover everything, simply not enough time, instead choosing to focus on a couple of areas we felt were critical.  Lastly, Chilmark also reviewed, made suggestions to and endorsed comments by a collaborative group that was submitted by the Markle Foundation.

Now time to rest and prepare for round two.

Dear HIT Policy Committee of ONC within HHS

Chilmark Research has followed closely the ongoing developments within HHS as it lays the foundation to successfully fulfill the legislative intent of ARRA and in particular the HITECH Act.  We recognize the significant task you have been given, the responsibilities they entail and recognize the numerous challenges that lie ahead.  Indeed, the small actions you will take may indeed lay much of the foundation for the success of future healthcare reform efforts.

Core to the successful execution of the HITECH Act is insuring that the significant amount of US taxpayer’s money that will be invested to digitize portions of the healthcare sector achieve objectives that indeed improve health, mitigate if not even lower costs and ultimately, deliver value back to the taxpayer that is readily recognized and appreciated.  Therefore, how clinician’s actually “meaningfully use” technology that is relevant to taxpayers is critical.

Also critical to the success of subsidized technology adoption is to set objectives sufficiently high to be meaningful, but not so high where the risk to reward ratio acts counter to adoption.

With these thoughts as a backdrop, our comments to the Draft Recommendations for Meaningful Use are as follows:
The Meaningful Use Workgroup has done an exemplary job of incorporating the intent of the legislation into the meaningful use criteria.  We also applaud their efforts to focus on what we wish to see as outcomes from the successful deployment and use of HIT and the tiered approach that is taken to raise the bar on meaningful use over the 2011-2015 time period.

Again, we reiterate that the inital draft of meaningful use was an excellent start to the process but unfortunately has many fatal flaws and most importantly, does not provide enough value back to the taxpayer, the citizen.  It is our sincere hope that follow-on recommendations more strongly advocate for the patient and their rights to what is ultimately their data .

Sincerely,
John Moore

Yesterday, myself and healthcare lawyer David Harlow gave our thoughts and views on ARRA legislation, the recently released draft recommendations for “meaningful use” and ” certified EHRs” in a social media experiment: Blog Post Radio.

The purpose of the one hour broadcast was to provide listeners with further background on what is actually happening with the ARRA/HITECH Act, how it looks like the $30B+ will be spent in support of EHR adoption and what providers need to be thinking about today to align with forthcoming requirements to receive reimbursement for EHR purchases.

This blog radio broadcast was hosted by Gregg Masters of San Diego a healthcare executive who has worked in the healthcare industry, primarily with providers for the last 30 some odd years.

ARRA, EHRs, Health Reform and ‘Meaningful Use’ Debate

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The proverbial doors to get your comments in on the Draft Recommendations for Meaningful Use that were released on June 16th close late this afternoon at 5pm ET.  Plenty has been written here by Chilmark Research on the topic of “meaningful use” (simply do a search) and we did a quick review on the recommendations last week if you need a refresher.

If you are in anyway impacted by these recommendations, we strongly encourage you to get your comments in.  Sources tell me that to date, surprisingly few comments have been submitted.

Following are the details cut n’pasted (bold & italics are ours for emphasis) right off of the HHS site.

Meaningful Use Comment Instructions

• Electronic responses to the draft description of Meaningful Use are preferred and should be addressed to:
  MeaningfulUse@hhs.gov
  With the subject line “Meaningful Use”
• Written comments may also be submitted to:
  Office of the National Coordinator for Health Information Technology
  200 Independence Ave, SW
  Suite 729D
  Washington, DC   20201
  Attention: HIT Policy Committee Meaningful Use Comments

One of the more intriguing sessions at the recent Microsoft Connected Health Conference was that hosted by Mark Johnston, International Business Development Lead for Microsoft Health Solutions Group (HSG).  During this session and follow-on conversations, Chilmark Research received a pretty clear picture of the HealthVault International strategy. Following is an overview of what we learned and our assessment.

Overview

Currently, Microsoft has had discussions with some 28 countries to date on how the HealthVault platform might be used to serve their citizens.  Of these 28, Microsoft has had more detailed,”scenario-based” discussions (specific use case scenarios, e.g. chronic care mgmt) with 11 countries and is in deep “contract-like” discussions with 6 countries.  Microsoft is seeing the greatest interest from European and some Asian countries.  In addition to these 28, Canadian telecom, Telus, will be the “Go to Market” (GTM) partner for HealthVault in Canada and Thai medical tourism destination, Bumrungrad Hospital will use HealthVault as part of a continuity of care process (see figure – DOPU stands for Drop-off, Pick-up) for US citizens. (Today, Bumrungrad serves roughly 60,000 US citizens/yr.  Technically, Bumrungrad is not an international instance of HealthVault, although they did present in the International session. Bumrungrad is simply creating a HealthVault account for the US citizen on the US instance of HealthVault – there is no separate instance of HealthVault in Thailand.)

The key driver for all countries is not much different than what we are experiencing in the US.  All are looking to reduce their medical risk profile by providing citizens and physicians better tools to manage health.  Primary objectives include:

• Support telemedicine with device connectivity (HealthVault Connection Center).
• Provide mechanisms/systems/tools, via HealthVault, to allow citizens to better self-manage and where possible minimize chronic diseases.
• Proactively engage citizens in their health by providing them with access to their personal health information leading to better, healthier and more knowledgeable decisions and subsequently, behaviors.

For example, Finland currently has 90% of its physicians using an EMR, but like most countries Finland continues to see healthcare costs rise.  Therefore, Finland is now looking at HealthVault as a critical component to take their national healthcare system to another level with deeper, direct engagement of their citizens and thereby mitigate cost increases. (In theory this makes sense, but there is no conclusive evidence that indeed this will work. Today, most are going on faith.)

The Business Model

As in the case of Telus, Microsoft intends to sell the HealthVault stack to a GTM partner in a given country.  The GTM partner will typically be a private entity, such as Telus, but Microsoft does not rule out the possibility that a government entity may also take on this responsibility (likely rare). It will then be the GTM partner’s responsibility to build the localization of HealthVault substantiation in their country that is in compliance with the country’s (and sponsor’s) policies, laws (privacy, security, consent, etc.), standards, language, culture and other requirements that are pertinent.  Obviously, it will also be the responsibility of the GTM partner to “sell” the platform to the sponsor (most often a government entity) and maintain the platform over time (maintenance upgrades, etc.).

Microsoft envisions the sponsor being directly responsible for defining the objectives of the HealthVault platform instance in their country.  Therefore, the sponsor will identify what specific attributes of the platform to emphasize and identify the partners (software & biometric devices) that will comprise the ecosystem of services to be offered to their citizenship.

Actual pricing model for HealthVault appears to be in a state of flux as Microsoft seeks to better understand what is most acceptable in what is still an extremely immature market.

Some Technical Challenges

There are a couple of key challenges for Microsoft and its GTM partners as it looks to propagate multiple instances of HealthVault around the globe.  They are:

1. How to build in localization features without altering the core functionality (data model, authentication, APIs) that comprise the HealthVault platform?
2. How to insure that all instances of the HealthVault platform are maintained as new features and functions are added to the core?

Sean Nolan, chief architect for HealthVault, outlined their strategy as follows: First, HealthVault’s architecture has two levels, one operational, the other policy.  The operational level includes the core features (APIs, SDK, data model, etc.) that will remain common to all HealthVault instances – these are not altered in anyway by the GTM partner or the HealthVault sponsor in a given country.  (Chilmark is assuming that within the “operational level” Microsoft will also enable support for various standards used in other countries.) It is at the policy level that HealthVault provides flexibility for country-specific modifications to be made (e.g., consent, record sharing, etc.).  Sean did go on to say that to date, the HealthVault model for authorization is globally acceptable.

To address the second challenge, Microsoft has language in its contract(s) with the GTM partner that their instance of the HealthVault platform must be updated every 6 months.  Currently, Microsoft updates HealthVault with new features/functions/fixes every 6 weeks or so.  Going forward, it will be releasing to clients platform upgrades on a quarterly basis.  Therefore, a given GTM partner and their sponsor can skip no more than one upgrade cycle.  This insures that all instances of HealthVault fall no farther than six months behind, thus staying current with new releases, fixes, API enhancements, etc.  This is extremely important as all these scattered instances of HealthVault could become nearly impossible to support.  Maybe even more importantly though is that multiple instances at varying levels of version cycles could endanger the attractiveness of HealthVault as a development platform for third party software developers and device manufacturers who add value, via the ecosystem effects of this cloud-based platform.

Assessment

As we have outlined in previous posts, Microsoft is developing a number of models to monetize the HealthVault platform, going international being one of them.  This is not too surprising as no one has figured out a direct to consumer model for a healthcare platform.  The only who has come close is WebMD, who is heavily dependent on pharma for advertising revenue, and WebMD is a closed platform, not the more open ecosystem that HealthVault is becoming.  Microsoft’s international strategy appears well-thought through and the architecture is in place to go abroad. It also appears that there is a ready market for this solution as virtually every country is struggling with some aspect of trying to control healthcare costs by lowering the medical risk profile of their population.

In moving into the international market, Microsoft is also creating far more opportunities for its ecosystem partners.  Among its software and device partners, we project that device partners will be the biggest beneficiaries in the near-term as most are already international companies and have the distribution network in place to take their products to market.  Software partners, of which most are small, typically build solutions to serve their markets of origin.  Some of these companies will successfully move into international instances of HealthVault, but most will not.

But there may be some potential problems ahead.

First, it is not clear whether or not Microsoft will GTM in a given country with only one partner.  For example, if the larger Infoway in Canada where to approach Microsoft tomorrow, would Microsoft also establish a relationship with them and let Telus and Infoway fight it out in Canada for garnering sponsor(s)? Certainly plausible but may also create conflicts that will come back to haunt Microsoft. (Received feedback from MSFT-HSG on this issue, their answer: in this scenario, they would allow Telus to sub-license HealthVault within Canada.)

Secondly, in all likelihood, GTM partners, acting on behalf of sponsors will make requests for platform features to add to core HealthVault functionality (operational level).  Question is, how will these requests be prioritized and acted upon?  The likely prioritization path will be similar to any large enterprise platform; poll other clients, assessed internal development goals and resources and make a go/no go decision. That is fine, but there will always be some clients who will want some level of customization/flexibility but it does not appear that such will be supported.

Another area where there may be an issue is on the policy front. Microsoft is a strong supporter of consumer rights to gain access and control their personal health information (PHI) and was one of the lead endorsers to the Declaration of Health Data Rights released Monday night.  But what if some country does not share these views, e.g., Google’s struggles with China? What if a country does not support this basic tenet of HealthVault, consumer access and control?  Will Microsoft refuse to do business with such a country/partner?  Also, what fail-safes are in place to insure that GTM partners do not abuse/compromise the rich PHI data that they are collecting in a given country?  Will that issue be left to the country where the instance is in place to address or will Microsoft exert some level of policy control via its contractural language?  A slippery slope indeed.

Lastly, we still do not have clear evidence that giving consumers access to their PHI actually modifies behaviors leading to lower medical risk profiles.  Yes, there have been a few studies of modest size that provide some andectotal evidence that such is the case, but honestly, the data is still pretty sparse.  We are operating more on faith here than clinical evidence and while Microsoft appears to be off to a good start, it remains to be seen just how much traction they will get longer-term.

The foundational element to knowledge, from which wisdom flows, is information.  Without information one can not begin to understand.  So why is it that we, as consumers, have such a hard time gaining access to our personal health records, our personal health information (PHI)?

Without access to that information, are we left to go forth blindly, without full awareness of the repercussions of our actions to our health? Do we put ourselves at risk if we must interact with multiple physicians who can not readily share our health records among each other? Can we adequately care for a loved one if we do not have clear, readily available information regarding their health condition(s) and the medications they may be taking?

Well folks, that is basically what we have today in the US healthcare system, a system that woefully lacks health information in a computable, digital interoperable form and even when digital records are available, they are not readily shared among physician practices and hospitals.  Many a physician has struggled to compile a complete record for one of their patients.  As for the consumer, well they are most often the last in line to gain access to their records, to their information and even when they do, that information can often be suspect.

For example, one person Chilmark Research recently spoke to told the story of how, when they asked their local hospital to allow them to move their PHI to a self-managed PHR, the hospital told them that would be a violation of HIPAA and they would not allow it.  Luckily, this individual did know HIPAA rules and ultimately prevailed, but that is a rare case as most consumers would not know how to fight the system to gain control of their records.

Another example came up last week during a conversation with John Phelan, founder of the new PHR start-up, ZweenaHealth. Their market differentiation is to act as proxy on behalf of the consumer to collect all of the consumer’s records, in any form factor (paper, digital, fax, whatever), and convert to a digital, CCR compliant record for an annual subscription fee.  John related the story of one healthcare provider who wanted to charge the consumer (via Zweena) several hundred dollars to fax a 7pg medical record to ZweenaHealth.  Apparently, the healthcare provider thought ZweenaHealth was a potential competitor and was loathed to release any information, even though the consumer/customer requested it.  Ultimately, ZweenaHealth was able to convince the provider that they were not a competitor and the PHI was released for a nominal fee.

It simply should no be this hard to gain access to one’s PHI – Period!

The healthcare system, unfortunately, is rife with such stories and we will not achieve any sense of healthcare reform if we do not get Joe the Plumber or Jane the Corporate Exec directly involved in better managing their health.  And might better health management begin with better information, leading to better knowledge and ultimately better, more healthy behaviors?

The Declaration:

Last night, a Declaration of Health Data Rights was nailed to the door of the healthcare establishment that demands, in the most simplest form, that consumers have four specific rights to PHI:

We (the people),

• Have the right to our own health data
• Have the right to know the source of each health data element in the record.
  
• Have the right to take possession of a complete copy of our individual health data, without delay, at minimal or no cost, If records exist in computable form, they must be made available in that form.
• Have the right to share our health data with others as we see fit.

These principles express basic human rights as well as essential elements of health care that is participatory, appropriate and in the interests of each patient. No law or policy should abridge these rights.

Now who in the right mind could ever deny such basic principles?  Doubt if even the high council in Iran would deny such rights.  So all you payers and providers, hand over the consumers’ PHI as we no longer wish to be held hostage by you. This information, is after all about us, not you.

Due to a tremendous workload at Chilmark Research, creating cogent, free content is expensive, at least to us.  Therefore, to provide value to you dear reader without taxing our synapses to the breaking point this post will give you a few highlights from te week that caught our attention.

How much is too much?

The recommendations for meaningful use paid a fair amount of attention to the issue of consumer/patient access to their medical records.  The big question, however, is just how much access is appropriate?  Does one let the consumer see absolutely everything within the record including all notes despite how esoteric they may be, challenging to understand and potential for mis-interpretation?  For some perspective:

A very thoughtful, extremely funny and intelligent physician who goes by the twitter handle of @doc-rob wrote about his own practice’s deliberations on the subject and the comments are just as insightful as his.

The Boston Globe had an article in today’s edition on Beth Israel’s decision to let their customers/patients have full access to the complete record.

And the Wall Street Journal’s own Health Care Blog also drew attention to the Boston Globe article with again, some great comments.

Outside of mental health, where there are some extremely valid reasons for not sharing clinician notes, the consumer should indeed have full access for as we have seen in countless other industry sectors, information liberation solves far more problems that it creates.

CCHIT looking to become contortionist?

This week, CCHIT’s Mark Leavitt hosted two townhall meetings to present changes that CCHIT is considering in its certification process.  Prompting these changes is CCHIT’s clear desire to be the go-to certification entity for all “certified EHRs” which is the only technology that will receive reimburse under the HITECH Act.  Going through the slidedeck our quick conclusion was that CCHIT is bending over backwards to try and address concerns in the market about their certification process.

What Chilmark likes about the proposed changes:

A three tiered process that acknowledges different technologies and architectures for EHRs (e.g. modular apps and roll-your-own) that fall outside of the common EMR vendor model upon which CCHIT was founded.

A pricing model that is fair and reasonable.

What Chilmark is not so crazy about:

Like anything, the devil is always in the details and what CCHIT presented is still pretty thin on details.  At first glance, we see a growing complexity in the certification process as often times, software does not abide by strict boundaries.  This is especially true from EMR-Comprehensive vs. EMR-Modular.

Not convinced that CCHIT has the resources available to keep up with technology developments and changes to insure innovative products reach the market quickly.  More complexity is typically a time sink of major proportions.

The HIPAA and EMR blog’s author, John did sit in on both CCHIT townhall meetings and has a good write-up/analysis that is worth the read.

Mark Leavitt also wrote a piece for California Health Care Foundation’s iHealthBeat providing his perspective on the monumental changes coming to healthcare and of course the great role his organization plans to serve in those changes.  My advice to Mark, don’t count your chickens before they hatch.

Get a Life

Last Friday, the Pew Charitable Trust released their latest study on consumer use of the Internet for health.  Chilmark has a lot of respect for their work which is always thoughtful, well-reasoned, applies good methodology and results always have a few surprises.  Unfortunately, have yet to read the full report, only the post that the lead reseacher, Suzannah Fox, wrote on the report.  Do know this though, if you are even remotely interested in understanding how the public is using the Internet to address their health issues and also want to understand underlying demographic differences, just go read the report.  I’ll be doing that myself on Sunday as I recover from the infamous Harpoon Brewery to Brewery ride tomorrow.

Just received an email this afternoon from Children’s Health Informatics Progam (CHIP) here in Boston announcing the release of a workshop derived document: Ten Principles for Fostering Development of an “iPhone-like” Platform for Healthcare Information Technology. Not sure if release was serendepidous or not but timing is interesting in light of yesterday’s release of Draft Meaningful Use Recommendations and today’s webcast by CCHIT outlining future certification processes.

The workshop itself came about as a follow-on to the paper CHIP researchers Mandl and Kohane published in NEJM last March.  Maybe with all that ARRA money floating about in the HITECH Act, ONC should just go ahead and build such an “Open” platform that supports modular apps to meet specific needs wihin this highly fragmented market.

Seriously, this needs some consideration.

Congress did grant authority in the ARRA legislation for HHS to develop an open-source EHR if existing vendor solutions do not adequately meet market needs. So, rather than build a full-fledge EHR which is almost doomed to fail in the market (despite what VistA promoters may argue) a better strategy may indeed be the building of an Open, iPhone-like platform with open SDK, open APIs, etc., heck, even throw in an AppStore (with an app review feature) and let the development community have at it.  This could really get things moving and accelerate adoption of HIT, especially in small practices where 80% of care is delivered.

Are you listening Washington?