Category Archives: Meaningful Use

Personal Health Records and the Seeds of Disruptive Innovation

April 26, 2004  President George W. Bush gave a speech to the American Association of Community Colleges in which he said “…Within 10 years, every American must have a personal electronic medical record,” Bush said. “That’s a good goal for the country to achieve. The federal government has got to take the lead in order to make this happen by developing what’s called technical standards.”

The HITECH Act of 2009 was signed by President Obama in February 2009, and made available some $30 billion over time to  hospitals and medical professionals who satisfied regulations for “meaningful use” of certified electronic health record technology.  This year the industry is beginning implementation of Stage 2 Meaningful Use that slightly ups the adoption bar for patient access to their own records. It requires 10% of a provider’s patients to actually view online, download, and transfer their health information.

The adoption of EHRs by healthcare institutions, however, is not the same thing as having a personal health record. The generation of EHRs currently deployed were designed for the provider organizations, not the patients who must deal with many providers over the course of their lifetimes. To realize the vision elaborated 10 years ago requires a Patient-centered record – one that can go with you throughout your life, rather than having fragments of information locked up in dozens of systems within different provider enterprises.Bluebuttonicon

To partially address this need a new specification has been evolving over the past few years known as “Blue Button”.


First implemented by the Department of Veteran Affairs, the tool has been used by millions of Veterans.  In June 2013, Todd Park, the current U.S. Chief Technology Officer and former Silicon Valley entrepreneur, said that over 88 million Americans now have access to their data via Blue Button and over 1 million have used it. The first iteration of the Blue Button specification fell short of what is needed to spark the development of functionally useful personal health record applications. The next generation specification, known as Blue Button+,  is intended to provide patients an easy way to directly transfer their data from provider systems into personal systems. It has a data structure that can be displayed more elegantly and also incorporated into new functionality. The data to be included is promising. The 2013 Blue Button+ Implementation Guide includes the following sections:

Blue button plus sections

The disruptive potential of Blue Button+ can be seen in the diagram below:


This architecture has the patient (Ellen) initiating a transfer from 3 of her providers’ systems to an application she has authorized.

The reason this technology will be disruptive is that it empowers patients to get their own data from different provider systems and into their selected consumer apps.  For example, this could allow startups and others  to create smart phone apps that also combine personal fitness trackers, personal health diaries, photographs, you name it, so that the consumer, Ellen, has it all in her pocket.  The patient who sees 3 doctors and visits 2 hospitals over 10 years (not uncommon in this age of changing jobs and health plans) can trigger the aggregation of their own medical records.

If widely implemented, this may eventually lead to the market disruption pattern documented in the works of  Harvard’s Clayton Christensen. The now dominant health information technology vendors may have to look over their shoulders at the startups that begin to climb the value chain, delivering useful and low cost solutions to market segments previously underserved by the established players.

And yet… is it real?  After the disastrous rollout of the Affordable Care Act’s crucial Health Insurance Exchanges we all have to pause and wonder if the federal government is capable of executing any complex information technology initiative. Last February, with great fanfare, the Blue Button+ Implementation Guide was announced, along with competitions for new Blue Button+ apps and a promise that a Blue Button Connector would be rolled out by the end of 2013. The Blue Button Connector will be a tool for consumers to find their health data to download and resources to make this possible. However, Mobihealth News reported that Lygeia Ricciardi, director of the ONC’s Office of Consumer eHealth , said at the Consumer Electronics Show in January 2014 that the Blue Button Connector rollout is delayed. She said that a beta may be available in late February 2014.

On the bright side, this is still primarily a technical specification. Unlike the Health Insurance Exchanges, the BB+ spec is not a big government IT project. Software to process apps that can use this data can be written by anyone with the coding skills.  It remains to be seen whether the  electronic health record vendors will make it work. This is why the data sources listed in the Blue Button Connector will be important to monitor.

As the enterprise electronic health record systems are opened up the data can be applied in new ways – under each patient’s control- to provide more tools for navigating their lives. These seeds of disruption offer consumers more informed choices, better tools, and over time can change the face of the healthcare industry.

The 10 year-old presidential vision of a personal health record for every American is getting closer. We should continue to expect resistance, both passive and active, from some industry stakeholders who want to use electronic health records as a “lock-in” strategy for customer retention. The role of federal leadership in developing technical standards, recognized by President Bush a decade ago, as implemented through the HITECH regulations, may yet create the seeds of  new innovation in health consumer empowerment.

Ed at meetup 2

Ed Butler is a founder and lead organizer of the Seattle Health Innovation Forum. He is currently conducting market research related to the convergence of personalized medicine and population health management.

FDA and 23andMe- is there a Hubris Gene?

Most readers of this blog may already know that 23andMe is an innovative Silicon Valley company backed by Google Ventures that has been providing affordable genetic tests to consumers indicating their genetic risks for certain diseases.  It explicitly does not provide diagnoses.  The recent controversy around the FDA’s crackdown on 23andMe has been very instructive.  There are important public policy issues surrounding FDA’s Warning Letter to 23andMe as outlined by Ezra Klein’s blog.  I think this episode can also be seen as a cautionary tale both entrepreneurs and the regulators.

I had been planning to get the 23andMe test before the November 22 Letter came out but because it was expensive enough at $99 I kept putting it off. In the first few days after the FDA letter, 23amdMe was still offering the service, so I ordered one.  It came a few days later to my mailbox:

23andme box

Before submitting the test I had to agree to the terms and conditions, that included these important caveats:

23andMe terms

Fair enough-  they are saying that this is not medical advice (I knew that already), and an acknowledgement that the genetic information I get will be incomplete and possibly in error.  They’re saying that if I can’t handle the information then don’t do it. I accepted the conditions and consented to have my results included in their growing crowd-sourced database that will be used by researchers to accelerate the pace of discoveries and cures.

Next I opened the box and found the test tube.  Looks pretty safe, doesn’t it?

23andme tube

I waited 30 minutes after eating or drinking anything and then mustered enough saliva to fill to the indicated line on the tube. I then screwed the top on and mailed it off to 23andMe’s processing center in Los Angeles.  I had been looking forward to getting the results until I saw 23andMe CEO Anne Wojcicki’s post  December 5th saying that customers who purchased the kits after November 22 (like me) will not have access to the promised health related results.  No discount, either, on the $99 unless I want a full refund and agree to cancel the test entirely. I am disappointed both in 23andMe and in the FDA. I understand why 23andMe had to back down, but am still disappointed not to get their interpretation of the data. I will get my unanalyzed DNA dataset and the ancestry information only. My disappointment with the FDA is that they over-reacted to what is still essentially an information service. I am curious about the assertion that this is a dangerous “device” and wonder if they have exceeded their mandate.

Hubris is a part of the human condition that has been documented since the bronze age. It is an overconfident pride. FDA’s letter asserts that “if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery”.  Patients do not do their own surgery. Before prophylactic or any other surgery a discussion would take place with the medical team. That is a good thing for consumers, and yes, it is disruptive to a paternalistic medical culture to have an activated patient asking questions about the evidence. The FDA declaration that this Personal Genome Service is considered a Class III medical device- the most restrictive classification-  seems to me to be an unreasonable escalation of what should have been the exploration of an open question. As Duke University’s Misha Angrist wrote of the FDA letter, “it reads like the letter of a jilted lover”.  Hubris indeed.

As David Dobbs pointed out last week in the New Yorker, “if the F.D.A. indeed insists on making 23andMe prove beyond doubt the validity of every single correlation, no genetic-testing service will be able to economically deliver medically relevant genetic information directly to consumers. It will destroy the industry and leave medical genetics in the hands of a medical establishment that has already failed to give people an easy way to obtain and use the elemental information in their own spit.”

What about other medical decision support services?

I have had similar questions about the “Meaningful Use” of  Electronic Health Record systems incentivized by the Center for Medicaid and Medicare Services via the 2009 stimulus package. Even though such systems automate clinical workflows and offer clinical decision support information to providers they are not subjected to FDA requirements for pre-market clearance and adherence to design controls of regulation-inspired “quality management” systems. This was in part because within HHS there was an internal debate balancing the FDA’s mandate with the need for speed in the implementation of the 2009 American Reinvestment and Recovery Act (ARRA). Fortunately for the public, there was enough internal pushback that the FDA regulators were held at bay. Had Electronic Heath Records been held to Class III standards, many of the products then, and now, on the market – especially the market leaders at the time- would likely have received similar letters as did 23andMe last month.

Lessons for Innovators

I see 3  lessons for entrepreneurs from the unfortunate drama of 23andMe vs FDA:

  1. Take the FDA seriously, even if you think it’s crazy that they think your product is a medical device.
  2. Find your local or regional biotech trade association and work with them to better understand the regulatory climate and how to be effective within it.
  3. Explore regulatory climates in countries outside the US. Most of the world’s growth in the next decade will be outside the US. The rapid growth of mobile internet access opens new opportunities for medical information services.

I look forward to the policy discussion about the classification of  health information services as medical devices. Hopefully the FDA can find a better balance than what we have seen so far. I hope that they do it soon.  I’m really curious about what’s in my 23andMe report that the FDA won’t yet allow me to see.

Ed at meetup 2

Ed Butler

3 Reasons To Postpone ICD-10

Six years ago I worked on a program to implement an advanced system of clinical terminology for OLYMPUS DIGITAL CAMERAthe National Health Service in England. The exciting new terminology was called SNOMED-CT. The   “old” terminology was ICD-10. I remember the terminology advisory meetings with clinicians and administrators about the limitations of ICD-10 and how SNOMED-CT would improve health informatics in the NHS.  I have  deja vu when I see similar arguments being made for implementing ICD-10 in the US,(see the HIMSS Open Letter to HHS published Feb 7th),  The push for standardized terminology is important for our healthcare system, but it is essential that this nation-wide mobilization around terminology infrastructure be able to deliver the promised benefits. It is becoming increasingly clear that ICD-10 is not the breakthrough we need.

I returned to the US in 2006 and worked with GE Healthcare and its development partners to develop more advanced knowledge solutions for health care. In my consulting practice I have focused on patient engagement and this has given me a new perspective on the need for actionable and expressive clinical terminology. This is a time to carefully consider the consequences of our choices.

I believe that the federal mandate to convert to  ICD-10-CM by October 2014 will be a step backwards. Here’s why-

  1.  Credibility,once lost is hard to regain. The advertised benefits of ICD-10-CM migration are grossly overstated. Just as many of us experienced in January 2000, the recollection of the pain to continue business as usual beyond Y2k was like having recovered from the flu. After the pain of implementing ICD-10, no one will want to touch clinical terminology infrastructure again for a generation. The hyped ICD-10 benefits of eliminating waste, population health, cost savings, patient experience will be revealed as empty promises. The arguments in favor of keeping the October 2014 deadline stated in the HIMSS letter  are an example of wistful thinking and will not stand the light of day once the real pain of the migration begins.
  2. ICD-10 is not worth it. The April 2012 Health Affairs article by Chris Chute, Stan Huff, John Halamka,and others presents compelling evidence that “the practical ability of ICD-10 to capture content typically contained in clinical records is not measurably better or worse than that of ICD-9-CM”.  They conclude that “ICD-10 CM conversion is expensive, arduous, disruptive, and of limited direct clinical benefit”. The authors of this analysis are among the most respected health informatics thought leaders in the world. The calls for delaying the implementation fo ICD-10  is not a rear-guard action by change-resisters but an appeal to reason by some of the most effective health change agents of our time.
  3. ICD-11 will be better because of its intrinsic alignment with SNOMED-CT. The investments made by the US healthcare industry to date in preparing for ICD-10 are not entirely wasted if  transformed into an infrastructure that supports ICD-11 prior to its deployment. Let’s avoid having to do another big terminology upgrade in a few years- or worse, being stuck for another 30 years with a labor-intensive administrative classification ontology in a world that needs clinical relevance. Please, let’s not populate patient databases with ICD-10 terms that only add complexity and provide minimal benefit to patients. A migration to ICD-11 and SNOMED-CT, properly orchestrated with ACO’s, payers, clinicians, and especially patients, offers a more credible approach that will spark innovation. Let’s take it.

That is why I believe the ICD-10 terminology conversion should be re-envisioned with an additional two or three more years so that it becomes worthy of the investment. With all due respect to the hard work of those who have been implementing ICD-10, let’s get it right this time. We may not have another chance for a generation.


The Engaged Patient: Convergence of Medical Informatics and Integrated Healthcare Marketing

All Way Walk

Awareness of “Patient Engagement” has grown over the past 5 years and will certainly accelerate now that it is included as part of the Stage 2 “meaningful use” proposed rules. The notion of consumer engagement initially grew from the advertising industry as a by-product of the increasingly interactive internet phenomena of consumers posting comments on corporate blogs. Razorfish, a consumer marketing firm, in 2011 argued that “Engagement isn’t just about a channel. It is about the consumer’s relationship with a brand, his or her ability to choose how and when to engage, and the value each channel represents.” In the health care context, there are many channels- from the nurse at the doctor’s office to the patient portal online. Patient engagement, to be successful, has to begin and end with the patient, on their terms, with their values and priorities first and foremost.

Increasingly consumers have immediate access to the views of their peers on many different subjects, not least of which is health care. A 2011 Pew Internet study on “peer to peer Healthcare” shows that “one in five internet users have gone online to find others who might have health concerns similar to theirs.”  According to Susannah Fox, associate director at the Pew Internet & American Life project, more than 80% of internet users have looked online for health information. 10% of adult cell phone users have signed up for a health application,, although many may have only used it once. Johns Hopkins University currently has 49 official studies underway as part of its Global mHealth Initiative to determine which mobile health applications actually work.

Innovation often occurs at the intersection of different industries and disciplines. The MIT Media Lab is a famed example of an interdisciplinary hotspot, where structured serendipity, contempt for silos, playful invention, and a group of “open minded and dangerously creative people” produce breakthroughs. Within healthcare the promise of engaging patients, especially those with chronic conditions, has the potential of dramatically improving their health outcomes and decreasing costs of complications. This is where the intersection of marketing and health informatics can have a breakthrough impact.

Integrated Marketing arose as a solution to the fragmentation of marketing communications. I like the definition from the Centre for Integrated Marketing below:

Integrated Marketing is an holistic discipline using the fractal concept of wholeness, where the whole is present in each part, as in DNA, to develop congruent, sustainable and high-value brand experience for all stakeholders.

In the case of Integrated Marketing, the starting point is core identity, and this is then articulated as strategy through the business model, products, brand, vision, cultural values and business evaluation (amongst others). It is also communicated in creative ways through marcoms and service/touch points.

When applied to Patient Engagement, the core “”DNA” is the patient’s own need to act, in collaboration with others, towards a better outcome. This need is especially accessible to integrated care delivery systems with shared risk for patient outcomes, such as Accountable Care Organizations and managed care systems.

In the April/June 2012 issue of the Journal of Ambulatory Care Management Angela Coulter, of the Department of Public Health at Oxford University,  outlines the evidence supporting Patient Engagement.  She outlines three areas where the evidence is strongest that patient engagement has beneficial effects: (1) improving health literacy, (2) shared decision making, and (3) care process improvement.

The Board of the American Medical Informatics Association published a white paper in 2009 that defined the core content for a medical subspecialty in clinical informatics in 4 areas: clinical informatics, clinical decision making and process improvement, health information systems, and leadership/change management.

imageThis core content is, of course, centered on the clinical context and care delivery organization medical and IT infrastructure. These are necessary areas for effective use of clinical informatics within and across the healthcare delivery system. To me, what to me seems missing in this content is a patient-centric orientation. This is not a criticism, but an observation that because the focus of the clinical informaticist is predominantly on improving care within the care delivery organization, through better work flow and improved clinical decision support for the medical, nursing, and allied health professionals.  The “engaged patient” can be part of this vision, and in the better health organization patient engagement is incorporated into clinical guidelines and care protocols.

The Electronic Health Record (EHR) is a key element of patient engagement. Patients need broader access to their record- far beyond the current proposed rule to provide access within 4 days. Patient engagement does not begin or end with the EHR. When it comes to actually connecting with patients outside the care environment (where patients live and interact most of their lives) it takes a different mindset and an expanded set of tools that are connected to the Patient’s life in a more holistic way that goes beyond “health care”. This is precisely the problem-space addressed by integrated marketing. The opportunities for collaboration between marketing  and clinical informatics professionals has never been greater.

Future posts will explore innovations in social media, mobile applications, and health services organizations to create an engagement model supporting patients actively involved in their own journeys towards better health outcomes.

Ed Butler, CEO Agate Point Consulting LLC

David Foster Wallace and the Meaning of “Meaningful Use”

Since my last blog post in early summer I’ve been working on a strategic project for an integrated delivery system.  I am excited about this project because of the great people who work there and because of the uncommon creative opportunities  of working with an organization that combines a research mission, a care delivery mission, and a healthcare financing mission.  As is my tendency, this has consumed all of my attention.  In the few minutes each day not devoted to thinking about “bending the cost curve” and providing healthcare consumers with new tools help them manage their health goals, I’ve been discovering the unique perspectives of David Foster Wallace (1962-2008), a brilliant young writer who died 3 years ago Sept 12.

For anyone not familiar with Wallace, the following Youtube links are from his 2005 commencement address at Kenyon College. It’s worth a listen.

It begins with the story of two young fish who encounter an older fish swimming the opposite direction, who says to them “Morning boys, how’s the water?”  As they swim on, one of the younger fish says to the other, “what the hell is water?”

The book he was working on at the time of this address, The Pale King, was released earlier this year.  It takes a very close look at the central moral questions posed in the Kenyon address, which concern the choices we make about what to pay attention to. On the axis of this question turns no less than the meaning of what we do.

The novel is set in an IRS tax return processing center in Peoria Illinois. Wallace is a master of stream of consciousness, narrated in different voices, reminiscent of James Joyce’s Ulysses, William Faulkner’s As I Lay Dying, and Robert Musil’s The Man without Qualities.  The tedious language of the prevailing vernacular is interspersed with glimpses into the minds of the people who work there and their efforts to make sense of it, (or not).

For those of us who pay attention to the Information Technology area of healthcare delivery systems, the phrase “Meaningful Use” has become tired. Born from the most visionary aspects of the American Recovery and Reinvestment Act of 2009, “Meaningful Use” of certified electronic health records technology has taken regulatory shape over the past 2 years. The $30+ billion stimulus payments to hospitals and “eligible providers” have required extensive retooling of software products supporting electronic medical records and the adoption of these systems.  The visionaries who crafted this legislation (less so the regulations) envisioned a healthcare system forced to change from its unsustainable cost inflation. It sought to protect US healthcare consumers from the suffering that could be caused by blind cost cutting and care rationing with a safety net of quality measures, so that healthcare providers and payers would be accountable not only for cost savings but also with improved patient care outcomes.  This vision still makes sense to me, but the execution has me worried.

The regulations that followed have identified various sets of quality measures. This link: an overview of the 44 measures and further links to the detailed specifications.  How are these measures going to be used to actually improve the quality of care?

The “water” we are swimming in has become heavily compliance oriented, as a result of mandates to implement ICD10 and HITECH/Meaningful Use .  The impressive investments being made in electronic health records, health information exchanges, and the quality reporting infrastructure still require a narrative to actually make a difference in the quality of care. To what end are these systems being put? Can we use these new tools to make sense of the data and to create new ways of interacting with the healthcare system that make it more effective?

The Pale King is a heartbreakingly unfinished work and we can only guess at where it was going. The manuscript was marked with various notes and asides that show where Wallace might have gone. Included in these notes were these statements as the two broad arcs of the book:  (1) “Paying attention, boredom, ADD, machines vs people at performing mindless jobs”, and (2) “Being individual vs being part of larger things-paying taxes, being a “lone gun” in IRS vs team player”.

Had this work been set in a healthcare setting in the post-2009 economic collapse these themes would not have worked as well because of the intrinsic satisfaction that goes with helping patients. Yet the fundamental question, of what we pay attention to, has a relevance that goes beyond the similarities in regulatory jargon. Our ability to question and creatively and compassionately move beyond our default settings, whether from regulatory, payer, care provider, or research perspectives, is what can produce meaningful use.

Bi Partisan Policy Council

Dr. Mostahari joined former Democratic Senator Tom Daschle and former Republican Senator Bob Bennett to discuss the promise of Health Information Technology today.  My favorite quote was from Sen. Bennett: “Everybody is in favor of Health IT”.

Tom Daschle said “This is the most transformational time in our history, with regards to Health.”

This was my first time seeing Farzad Mostahari, MD, the new National Coordinator for Health Information Technology, in action.  His bow tie certainly was an indication that he is not David Blumenthal, at least in the gravitas department. His message, though, was just as clear and welcome as that of his predecessor. He even invoked Clayton Christiansen’s concept of disruptive innovation as he buoyantly described the efforts of Open Source volunteers in support of the Direct Project, calling it a “Do-ocracy”.  It’s about those willing to do the work, not just talk about it, that has resulted in the creation and implementation of a new standard for exchanging clinical data within one year . That’s leadership I can support.

Brand Building and Healthcare IT

At a press conference in Washington DC today, top executives from five prominent health systems announced a consortium to securely share electronic patient information with each other. The members of this consortium include the Mayo Clinic, Geisinger, Kaiser Permanente, Intermountain Healthcare, and Group Health Cooperative.  It is notable that these organizations do not compete with each other in their primary geographic areas. Each has significant credibility in their own areas, and can legitimately aspire to national and even international visibility. In the ongoing restructuring of healthcare delivery models, such organizations are evolving into post-enterprise players, with infrastructure and organizational capabilities that transcend traditional company boundaries.

This announcement was more significant as a statement of organizational commitment to a new vision of healthcare than as any kind of new technical breakthrough accessible only to large IDNs.  Standards-based electronic patient information exchange technical capabilities are becoming commonplace as a result of federal certification requirements for Electronic Health Records technology. Accelerated by the ARRA stimulus funding, hospitals and providers who establish meaningful use of this technology are eligible for incentive payments through Medicare and Medicaid. What is remarkable about this Care Connectivity Consortium is that these institutions are smart enough to leverage their technology investments to enhance their brands as patient-centered visionary organizations. In the press conference each institution conceded that the number of patients who actually cross their organizational boundaries is rather small. As Marshall McLuhan once pointed out, the medium is the message, and the visual impact of these five health systems literally aligned at the same table spoke volumes about the real message, which is that these five organization are at the head table of using IT to advance patient benefits, and to advance their brands.

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