A Milestone for Device Interoperability

What is standards harmonization?

I describe it as the parsimonious number of standards required to meet the requirements of stakeholders. It is achieved by closing gaps and eliminating redundancy.

Can we always reduce the number of standards in a domain to 1? Not necessarily. Sometimes the best we can achieve is 2 with mapping between them or 2 initially converging over time to 1.

In the past, we've had multiple interoperability standards for devices. Earlier this year, HITSP challenged IHE and Continua to converge their work as part of the HITSP Remote Monitoring Use Case.

The Continua Alliance, a non-profit, open industry coalition of the more than 200 healthcare and technology companies joined together in collaboration to improve the quality of personal healthcare, has been focused on interoperability standards for consumer products. It wanted "fast and light" device standards that could easily be deployed with products in the home.

Integrating the Healthcare Enterprise (IHE), an initiative of healthcare professionals and industry to improve the way computer systems in healthcare share information, has focused on more complex devices such as those used by providers in hospitals and clinics.

Yesterday, Continua and IHE announced a breakthrough. They have agreed to a single set of content, transport, and vocabulary standards that work for all devices - home-based and hospital-based, simple and complex. This means that the industry is free to innovate and regardless of the devices created, they will be interoperable.

What standards did they choose?

Content - HL7 v2.6 messages using IHE PCD-01
Vocabulary - Constrained to IEEE/ISO 11073-20601/11073-104xx nomenclature
Transport - Web Services transport based on WS-I Basic Profile

Here are few comments by the leaders of this effort:

"IHE believes that this collaborative breakthrough offers enormous benefits to US citizens and their physicians. This helps accelerate the deployment of convenient and reliable home-based health monitoring and care, and facilitates many other forms of remote monitoring as well. Together, Continua and IHE have finally made it possible for vendors of Medical Devices and Personal Health Devices to efficiently send patient data to the Personal and Electronic Health Records vendors using a single unified interoperability standard that is endorsed by HITSP."

Elliot B. Sloane, PhD
Co-Chair, Integrating the Healthcare Enterprise (IHE) International Executive Director, Center for Healthcare Information Research and Policy


"The Continua Health Alliance appreciates the opportunity HITSP has afforded to work with IHE to provide a harmonized approach for the Remote Patient Monitoring Use Case with an open architecture, international, standards-based solution. This will facilitate an ecosystem of connected technologies, devices, and services that provide a compelling way to meet the challenges of increased access, improve outcomes for patients, and ultimately reduce overall healthcare costs."

Rick Cnossen
Director, Personal Health Enabling, Intel Digital Health Group (DHeG)
President, Continua Health Alliance (www.continuaalliance.org)


I want to offer my congratulations and thanks to IHE and Continua for this achievement. Their leadership illustrates the finest characteristics of harmonization achieved by assembling smart technical people, aligning mutual interests, then moving forward to converge on a single approach.

Bravo! All device stakeholders will now benefit from a single universal set of standards used to connect devices to EHRs and PHRs.

The FY10 HMS IT Operating Plan

Every year I work with all the stakeholders at Harvard Medical School to develop an operating plan. Here are a few observations about the process:

-In an economic downturn, governance is very important to triage projects, set timelines, and allocate resources. Budgets define the supply of resources. Governance helps balance supply and demand. During my tenure as CIO, we've had workgroups for research, education, and administrative customers, but this year I'm formalizing governance by creating an overall IT Steering Committee comprised of research faculty, educational leadership, and administrative Deans. My educational, administrative and research workgroups will report to this overall IT Steering Committee.

-I have 5 direct reports at HMS who serve as the single point of accountability for Administration/Finance, Education, Research/Customer Service, Infrastructure, and Technology. Each is responsible for translating the strategic and business priorities of their customers into the tactics listed in the operating plan.

-Once the operating plan is complete, my role as CIO is to ensure appropriate capital budgets, operating budgets, and staffing are in place to execute the plan. 2010 will require especially close collaboration with the leaders at HMS to balance the necessary resources with the need to be frugal in a challenging economy.

-Major themes in the FY10 IT Operating Plan include enhanced enterprise infrastructure (especially storage), workflow applications to promote departmental efficiency, and web-based software as a service tools that reduce costs while improving service to all stakeholders.

-I summarize the yearly effort to develop the plan as

Strategy - document the goals and business strategy of all stakeholders, translating them into operating tactics.

Structure - ensure the IT organization is optimally configured to execute the tactics.

Staffing - populate the structure with the best people to do the work.

Budget - put the capital and operating budgets in place so that the necessary resources are available to execute the scope of work in the timeline needed.

Processes - Define the workflow and procedures that are needed to support project management, customer service, and continuous improvement.

Here's the initial version of the FY10 HMS IT Operating Plan. I look forward to a great year ahead.

Cool Technology of the Week

Before my trip to Japan, I attended the New England Healthcare Institute Medication Adherence Expert Roundtable on Thursday July 23rd, 2009. The purpose of the roundtable was to prioritize activities that would encourage patients to be more compliant with the medications, especially those with chronic diseases such as diabetes, congestive heart failure and COPD. Recommendations from the group included better patient education, enhanced use of IT such as medication reconciliation, and healthcare reform which ensures clinicians have the time and incentives to coordinate and manage all medications for their patients.

One technology that we discussed was an intelligent pill bottle for the home from rxvitality.com and it's my cool technology of the week. Using technology similar to the Ambient Orb, the intelligent pill bottle flashes to indicate when it's time to take the medication inside the bottle. When the bottle is opened it sends telemetry back to a portal which can be used to track patient medication adherence.

The device includes a small wireless access point for the home, making the device plug and play. No cell phone plan, configuration or special software is needed - just an internet connection.

A pill bottle that notifies the patient when medications are to be taken and informs the clinician when medications are actually taken.

That's cool!

Funding for HIEs and RHITECs arrives

Yesterday was a landmark day - the HIT Standards Committee approved the quality, clinical care, and privacy/security standards that serve as certification criteria and support meaningful use. At the same time, HHS released $564 million for Healthcare Information Exchange to be given to States/State Designated Entities to accelerate interoperability implementation and $598 million for Regional Healthcare IT Extension Centers (RHITECs) which are applied for competitively (not distributed via state government) to accelerate EHR adoption.

Of interest, the range of award for HIE is $4,000,000 to $40,000,000. Fifty awards will be given.

The range of award for RHITECs is $1,000,000 to $30,000,000 with an average of 8,543,000
Award Floor $ 1,000,000. Seventy awards will be given.

The press release is below.

CHICAGO, IL – Vice President Joe Biden today announced the availability of grants worth nearly $1.2 billion to help hospitals and health care providers implement and use electronic health records. The grants will be funded by the American Recovery and Reinvestment Act of 2009 (ARRA) and will help health care providers qualify for new incentives that will be made available in 2010 to doctors and hospitals that meaningfully use electronic health records.

“With electronic health records, we are making health care safer; we’re making it more efficient; we’re making you healthier; and we’re saving money along the way, ”said Vice President Biden. “These are four necessities we need for healthcare in the 21st-century.”

“Expanding the use of electronic health records is fundamental to reforming our health care system,” said HHS Secretary Sebelius. “Electronic health records can help reduce medical errors, make health care more efficient and improve the quality of medical care for all Americans. These grants will help ensure more doctors and hospitals have the tools they need to use this critical technology.”

The grants made available today include:

Grants totaling $598 million to establish approximately 70 Health Information Technology Regional Extension Centers, which will provide hospitals and clinicians with hands-on technical assistance in the selection, acquisition, implementation, and meaningful use of certified electronic health record systems.

Grants totaling $564 million to States and Qualified State Designated Entities (SDEs) to support the development of mechanisms for information sharing within an emerging nationwide system of networks.

The Extension Center grants will be awarded on a rolling basis, with the first awards being issued in fiscal year 2010. Grants to States will be made in fiscal year 2010. Those interested in applying for these grants may visit http://HealthIT.HHS.gov for more information.

“With these programs, we begin the process of creating a national, private and secure electronic health information system. The grants are designed to help doctors and hospitals acquire electronic health records and use them in meaningful ways to improve the health of patients and reduce waste and inefficiency,” said Dr. David Blumenthal, National Coordinator for Health Information Technology. “They will also help states lead the way in creating the infrastructure for health information exchange, which enables information to follow patients within and across communities, wherever the information is needed to help doctors and patients make the best decisions about medical care.”

The Department of Health and Human Services will also provide additional assistance to health care providers through the Health Information Technology Research Center (HITRC). The HITRC will gather relevant information on effective practices from a wide variety of sources across the country and help the Regional Extension Centers collaborate with one another and with relevant stakeholders to identify and share best practices in EHR adoption, effective use, and provider support.

The Next Deliverables of the HIT Standards Committee

Today in Washington the HIT Standards Committee met to discuss the latest deliverables from its workgroups - Clinical Quality, Clinical Operations and Privacy/Security.

A few highlights:

*The workgroups presented the standards needed to support meaningful use and certification criteria. A certified EHR must meet the functionality criteria currently being developed by ONC but also must be capable of supporting the standards defined by the HIT Standards Committee workgroups.

*The standards themselves apply to capabilities that need to be included in the products for certification, and the use of those capabilities to codify patient data, and to calculate and report quality measures constitutes the 'meaningful use'.

*The theme for the meeting was convergence - after countless hours of work, today's deliverables included the synthesis of the efforts of all three workgroups, recommendations of the policy committee, and public comment.

The Clinical Quality workgroup presented 30 measures of quality and the data types required for each. Working collaboratively with Clinical Operations, specific content and vocabulary standards were selected all but 6 data elements, 3 of which are for one quality measure.

The Clinical Operations workgroup presented the content and vocabulary standards supporting meaningful use. Importantly, there were no gaps in standards needed to support all 2011 meaningful use criteria. The workgroup was very thoughtful about the maturity of standards and presented a gradual transition plan, allowing some variation (PDF, document images, free text) in 2011, but eliminating these unstructured documents for 2013. Their work included messaging formats (such as HL7 2.51) and document formats (such CDA/CCD), and all the vocabularies necessary for semantic interoperability (such as SNOMED-CT, RXNORM, UNII for allergies, and LOINC for labs). Note that the work of Clinical Operations describes the exchange of data between organizations, not the data model, architecture or implementation details within an organization.

The Privacy and Security workgroup presented the authentication, authorization, auditing and secure data transmission standards. Note that Privacy and Security includes standards for use in EHR products, the infrastructure that hosts them and best practices. Their work does include protecting data inside an enterprise as well as data exchange between enterprises because security is an end to end process. Security is as strong as the weakest link in the data exchange. Just as with the Clinical Operations workgroup, a great deal of thought went into the timeline when standards should be adopted, enabling a glide path from the present to stronger security. There were no gaps in the standards needed for 2011, although additional work on consent management and consumer preferences will be done to support later years, ONC, the Standards Committee and HITSP will work on consumer preference standards together in upcoming meetings.

The HIT Standards Committee also decided to establish a workgroup to focus on adoption/implementation issues.

All of the workgroup deliverables were accepted by the Committee and have been submitted to ONC as guidance for the regulation writing process.

A very impressive body of work. Thanks to all the workgroup members, the HITSP tiger teams, and ONC for making it all possible.

The Road Less Traveled

I'm back from Japan, physically and spiritually refreshed, ready to embrace my jobs , my blogging, and my outdoor activities with new vigor.

In previous years, my vacations have been about movement - hiking the John Muir trail, climbing in Yosemite, and exploring the outdoors with my family.

This year's trip to Japan was about people. My family and I had remarkable experiences that were not about traveling to every tourist spot, taking a few photographs, then shuttling to the next location. Instead, we based our ourselves in Kyoto for 2 weeks and in the Inland Sea (Miyajima) for 3 days, spending time with shopkeepers, craftsman and friends. Here a few examples:

We had the opportunity to spend a few hours with the President of Shoyeido Incense, Masataka Hata, the 12th generation leader of the company. He led us in a traditional Japanese incense ceremony (Koh-do), teaching us the details of refined arts from the 1600's.

We had the opportunity to meet with the owner of Horaido Tea, Nagahiro Yasumori, whose family has sold tea in Kyoto since 1803. He taught us how to make the ideal cup of Gyokuro and Sencha green tea.

We spent an afternoon with Ken-ichi Utsuki, owner of Aizenkobo workshop, a traditional Japanese natural indigo dying and textile firm. He and his son fitted me with a Samue (Japanese workclothes for Zen monks and tradespeople).

We met with Kunimi Naito and her family, makers of traditional Japanese Geta (wooden sandals) in the Gion (Geisha) district of Kyoto. They carefully studied my feet and are making a custom pair of geta for my 27cm western-sized foot.

We met with a Sake brewer and tasted the range of his handmade Ginjo and Daiginjo sakes.

We viewed the bonfires of Obon with faculty members from Kyoto and Keio University.

I played Shakuhachi in a 500 year old mountaintop temple overlooking the Inland Sea with a Zen monk who played a Conch shell.

We made traditional Japanese sweets (Wagashi) with a master craftsman.

We had incredible Zen meals in small family run restaurants such as Kiko

I want to thank our Japanese hosts, Dr. Hiroyuki Yoshihara and Michiko Yoshida for making it all possible.

There are so many memories and spiritual experiences to describe that I will use the next several months on my Thursday blogs to share everything I learned about traditional Japanese culture from the master craftsman who taught me over the past two weeks.

On the Road

For the next two weeks my wife and I will be on the road in Japan, meeting our 16 year old daughter in Japan, where she's spent the summer in intensive Japanese language study. My blog entries will be episodic but I'll remain connected via my 3G Blackberry. I'll be giving a lecture at Kyoto University but most of the trip will be seeing a side of traditional Japan that most tourists will not see.

We'll celebrate our 25th wedding anniversary in temples with a history of bringing good luck to relationships.

We'll make traditional Japanese rice confections in a small shop in the Gion.

We'll eat blue-green Tofu, okara in yuba handmade in a 10 seat restaurant on the banks of the Kamagawa.

We'll join a sake maker on the roof of his factory for a view of the bonfires of Obon lit on the mountains around Kyoto.

We'll shop for mountain yam and daikon pickles in the mile long farmers market hidden in the arcades of Teramachi.

We'll drink Green Tea at Uji in the oldest teashop on the planet.

We'll stroll Zen gardens in Ohara north of Kyoto.

We'll explore the temples west of Kyoto and then board a small boat to ride the rapids back to the city

We'll travel to Miyajima and kayak the Inland Sea and visit shrines only accessible by boat built by fisherman and pirates.

I'll play the Shakuhachi from the top of Mt. Misen near the fire that Kobo Daishi lit in the 1600's and is still burning.

During our entire trip, we'll stay in small traditional Japanese inns - Ryokan.

Normally, I would go climbing in the Eastern Sierra for my yearly August time away, but the opportunity to travel with my wife and daughter in Japan is a very special opportunity. My daughter heads off to college in 2 more years, so we'll treasure the time with her as our Japanese interpreter and sometimes tour guide, given her experience spending the entire summer there.

I'm hoping the new few weeks are quiet in Washington, as HHS moves to regulation writing mode. You can be sure I'll keep you informed via my blog and Twitter.