Friday, January 30, 2015

The Interoperability Roadmap

On Thursday, CMS announced their intent to update the Medicare and Medicaid Electronic Health Record (EHR) Incentive Programs for 2015 and beyond, reducing the reporting burden on providers, while supporting the long term goals of the program.

On Friday, ONC released the Interoperability Roadmap and the Standards Advisory.

A busy week.  What does it all mean?

The CMS announcement includes planning for a Spring 2015 rule that:

*Realigns hospital EHR reporting periods to the calendar year to allow eligible hospitals more time to incorporate 2014 Edition software into their workflows and to better align with other CMS quality programs.
*Modifies other aspects of the program to match long-term goals, reduce complexity, and lessen providers’ reporting burdens.
*Shortens the EHR reporting period in 2015 to 90 days to accommodate these changes.

It’s a positive sign that HHS leaders are listening and responding to stakeholders.    Meaningful Use Stage 2 contains numerous goals that require an ecosystem/marketplace to develop first.   The HIE marketplace is just developing and usable apps for patient view/download/transmit are still 6 months away.   The new timeline gives us the flexibility we need to do these projects right, leveraging  the market foundation that is developing.

The draft Interoperability Roadmap released by ONC describes the current market and issues in interoperability.

It aligns well with the work of the Jason Task Force, recognizing the role of the private sector and the importance of market-based networks.   It supports the move to modern internet interoperability conventions (including RESTful APIs like FHIR)

It wisely suggests  “non-government governance” for health information exchange rather than trying to create a single top-down nationwide governance entity.

It focuses on the importance of clarifying HIPAA to reduce confusion and misconceptions about HIPAA restrictions and enablers.  For example, does everyone know there is no such thing as HIPAA certified software and there are no restrictions on giving patients access to their own data?

The Roadmap does have a few areas of concern.   It suggests that States become more active in the area of interoperability.   We need to be careful with this approach or else we’ll create 50 interoperability silos given variation in State laws.  The new economic incentives of accountable care organizations will motivate vendors to address health information exchange needs based on business cases, not geography.

The Roadmap needs to describe a few more concrete steps that government should take to support the listed goals.  Increasing value-based purchasing and having federal agencies accelerate standards-based interoperability are very good, but there are other levers to consider such as creating reusable components at scale (i.e. a nationwide provider directory), aligning quality measurement programs/aligning quality measure reporting with modern interoperability standards, and harmonizing other health care regulations with interoperability conventions (i.e. community health center, nursing home, and home health reporting and regulation).

ONC is currently accepting public comments and key commitments on the draft Roadmap for approximately 60 days which will end at 5pm ET on April 3, 2015.

The “Standards Advisory”  companion document does specify some standards that are mature or becoming mature such as HL7 2.x, CCDA, and FHIR.   However, it also includes standards that are not likely to achieve maturity based on the  objective criteria outlined by the HIT Standards Committee.   I would advocate for leaving some of the boxes blank, since no mature or becoming mature standards are available for them.

Overall, I give ONC kudos for their articulate summary of where the federal government would like the industry to focus.   The market is making tremendous progress at this point, and the roadmap is a useful directional guide.

Thursday, January 29, 2015

Unity Farm Journal - The 5th Week of January 2015

Several people have emailed me asking about my well being, given that my blog posts have been delayed this week.   I’m fine - my excuse is snow.   30 inches over 15 acres is a lot of snow to move.

From Tuesday to Wednesday this week, we had “Stormageddon”, zero degree temperatures, 40 mile per hour winds, and nearly 3 feet of snow in a 24 hour period.   The roads were closed and all the doors on the farm were blocked.    We were saved by the Terex front loader, which can move 1000 pounds of snow (or manure) at a time.

I spent Wednesday doing storm cleanup, carving a barnyard for the ducks, chickens, and guinea fowl, creating paths for the alpaca between the barn and the hay feeders, and ensuring the dogs had a place to run.   I shoveled out bee yard so that all 12 hives had open ventilation on all sides.   I cleared the driveways, gates, and paths around the house.

We kept the animals dry and warm.   We gave them extra food and water.   We use the Terex to move manure from the barn to the compost area.

We were very prepared for this winter, with all the right tools, supplies and infrastructure to deal with it.   We had spent numerous weekends doing woodland management to prevent the collapse of dead or dying trees.    We filled all our gas, diesel, and propane tanks to the top.   We ensured we had spare food supplies for us and all the creatures.

Below are a few photos of the farm at the depth of winter.  Now that tons of snow are cleared, I can return to blogging about the recently released ONC Interoperability Roadmap, Standards Advisory, and CMS revisions to Meaningful Use - coming soon!

Here's what 30 inches of snow looks like

The alpaca like cold, but do not like snow

The Great Pyrenees love snow

and here's a movie of what they like to do in it.

The Apple Orchard is covered in a thick white blanket

And more snow arrives tonight.   Where will I put it?

Wednesday, January 28, 2015

The January HIT Standards Committee

The January HIT Standards Committee focused on two important topics, the future of the Standards and Interoperability (S&I) Framework and the xtandards needed for provenance i.e. who generated the data and I can I trust it?

Stan Huff and Arien Malec presented the process that the Standards & Interoperability Task Force  will use to evaluate the best way to harmonize standards in the future.   Typically Standards Development Organizations (SDOs) create and curate standards but sometimes there is a need to select among competing standards or combine the work of multiple SDOs into an implementation guide.   The Healthcare IT Standards Panel (HITSP) did this kind of harmonization.   When HITSP was  sunsetted during the transition from the Bush to the Obama administration, the S&I Framework was created to fill the harmonization role, since the Healthcare IT Standards Committee (HITSC) served in advisory capacity to ONC, not doing the granular work of implementation guide writing.     Questions to be asked  by the Task Force include:

Is there a continued need for the S&I Framework (or an equivalent process) to advance standards and implementation specification development?

The task force will evaluate the “What” (what should be done) and the “How” (by whom, in what forum, with what processes)

We all look forward to their work.

Lisa Gallagher presented the work of the Data Provenance Task Force.  Their  remarkable set of recommendations that were applauded by all.

The Task Force recommended that the Data Provenance Initiative should focus on the following:

Where did the data come from? (“source provenance”)
Has it been changed?
Can I trust the data?

The Task Force recommended that these questions be answered using 4 transaction types, in the following order of priority (although they are roughly equal in priority)

*With exchange of data between EHRs
*At the point of origin/data creation in an EHR or HIE
*With the transfer of data from a Patient Controlled Device (PCD) or a Personal Health Record (PHR) to an EHR system
*At the point of data creation in a PCD or PHR

They recommended that the CCDA and FHIR be the target technologies for provenance standards taking into account existing work including

*CDA/C-CDA Provenance
*FHIR Provence Project
*Privacy on FHIR Projects

Finally, they recommended that for health information exchange, both push (Direct) and pull (SOAP/REST query/response), that the provenance of the content should be lossless ie. there is data integrity from the point of origin to the point of use.

Much discussion followed and the Committee agreed that we needed to define lossless i.e. what if the data is mapped into a different vocabulary or different format?   Arien Malec agreed to prepare a straw man definition of lossless.

The committee voted to support these recommendations and formally deliver them to ONC.

The next few months will be very busy for the HIT Standards Committee as we review the Federal HIT Stategic Plan, the Ten Year Interoperability Roadmap, and the Meaningful Use Stage 3 Notice of Proposed Rulemaking.    Exciting times ahead.

Thursday, January 22, 2015

Unity Farm Journal - 4th week of January 2015

The cold of late January has been hard on our living things and we’ve sorted all our produce to eliminate cold damaged fruits/vegetables in the hoop house, root cellar, and forest.  

The apples from this year’s harvest are still fairing well.   Empire, Macoun, Winesap, RedSpy, and Rome are still crisp.   The Spencer apples have softened and are beginning to mold.  We composted about half a bushel.

The root vegetables - beets, daikon radish, and turnips were kept in soil until late December.   At the moment, they are still crisp and fresh, ready to be turned into soups, salads, and canning.

The squash harvested in October has started to develop mold and soft spots.   The ducks and chickens enjoy them, so we split the squash and laid them out for the poultry.

All our seed catalogs have arrived and with last week’s seed planning, we’re ordering everything for our first planting in March.

As usual, we continued harvesting wood, splitting logs, and maintaining the property this week.   I look back on the past two years and I’m amazed at how far we’ve come, dedicating every weekend to maintaining the land.

We walked the property and planned our 2015 permaculture planting.   The new chestnut trees will go in along our northern border.   The paw paw trees will be planted in the understory behind the cider house.    The rice will be tested in a low-lying portion of the orchard.

This weekend will be focused on more indoor tasks - maybe we’ll get to the skirting of alpaca fiber so we can produce the yarn from our 2014 sheering.   A farmer’s work is never done.

Wednesday, January 21, 2015

The Experience of Interoperability Thus Far

As I travel across the country and listen to CIOs struggling with mandates from Meaningful Use to ICD-10 to the HIPAA Omnibus rule to the Affordable Care Act, I'm always looking for ways to reduce the burden on IT leaders.

All have expressed frustration with the health information exchange (HIE) policies and technologies for care coordination. quality measurement, and patient engagement.

As a country, what can we do to reduce this anxiety?

Meaningful Use Stage 1 brought some interoperability especially around public health reporting. Stage 2 brought additional interoperability, with well defined content, vocabulary, and transport standards for transitions of care.

Most CIOs have implemented certified EHRs and the required standards.  Here’s a capsule summary of what I’ve heard

HL7 2.x
HL7 messaging addresses lab result and public health use cases very well.   Lab results interfaces are straight forward, however there is still some need to reduce optionality in implementation guides so that the average lab interface costs $500 and not $5000.    Public health transactions for immunizations, reportable lab, and syndromic surveillance are standardized from a content perspective but  there is still a need to specify a single transport mechanism for all public health agencies.

CCDA documents address transitions of care use cases reasonably well.  CCDA is easier to work and
parse than CCD/C32 because it has additional constraints and specifications, but there is still enough optionality that merging CCDA data into an EHR can be challenging.    In addition, most EHRs generate a CCDA automatically and include all data that may possibly be relevant.  In some cases, this leads to C-CDAs that are rendered at 50+ pages.   We need to reduce optionality so that CCDAs are easier to generate correctly and parse.  EHR workflow needs to better support the creation of clinically relevant documents with narrative and data more specific to transitions.

Direct was a good first step for transport - we needed to pick something.  We could have required sFTP, REST, SOAP, SMTP/SMIME or even Morse Code as long as it was completely standardized. Unfortunately, we picked multiple options.   Some EHRs use XDR (a SOAP transaction) and some use SMTP/SMIME.   Whenever standards have an "OR", all vendors must implement an "AND". XDR must be translated into SMTP/SMIME and SMTP/SMIME must be translated into XDR.   The reality of Direct implementation has show us that this optionality provides a lot of plumbing challenges.   Certificate and trust issues are still an ongoing project.   Getting data from medical devices via Direct is challenging since devices tend to use heterogeneous transmission protocols. Finally, SMTP/SMIME was never designed for large payloads of multiple files, so sending datasets greater than 10 megabytes can be a struggle.   The use of XDM for zipping files before they are sent is overly complex to use as part of a transport protocol.

Although Direct works, it is often not well integrated into the EHR workflow.

FHIR, as discussed in multiple recent posts, can help address these challenges and leverage the lessons learned.  The FHIR concept is that every EHR will provide a standardized interface for the query, retrieval, and submission of specific data elements and documents using a web-based RESTful transport mechanism and OAuth security.   This use case can easily support unique modules or “bolt on” application functionality to EHRs.    It significantly simplifies the interfacing challenge, works for large payloads, and minimizes optionality.   There are no multiple transport options, no certificates to manage, and the query/retrieve processes can occur behind the scenes, enabling smoother workflow.

FHIR can even be helpful as a transition strategy while Direct is still used for pushing payloads between EHR.   If FHIR/REST/OAuth replaced the XDR/XDM options of Direct, that provides a glide path to the eventual end to end replacement of Direct with FHIR

Once FHIR is available, EHR vendors should design a user experience that follows the IEEE definition of interoperability - “the ability of a system or a product to work with other systems or products without special effort on the part of the customer. "

In summary, think of HL7 2.x as good enough for messages  pushed between systems,  Direct/CCDA as suitable but challenging for pushing XML documents between systems, and FHIR as a means to integrate multiple platforms via the use of application program interfaces that support the simple query/retreat/submission of data among applications.

FHIR will solve many of our interoperability challenges with appropriate support from EHR developers for clinically relevant workflow. We have to be careful not to oversell it, but for many use cases, FHIR is our best hope for the future.

Thursday, January 15, 2015

Unity Farm Journal - Third Week of January 2015

The third week of January is generally the coldest, most bitter time in the New England winter season.  Temperatures dip to the single digits, snow/ice/winter mix cover the barnyard, and shoveling manure requires an ice chipper.   Eggs laid overnight in the chicken or duck pen crack when they freeze solid.   Every creature gets extra food to keep their internal furnaces stoked.

The ground is frozen and all the outbuildings are below freezing inside.  Even the plants in the hoop house are need to be protected by row cover blankets.   Nothing will germinate at below freezing temperatures.

Much of the work of the farm slows.

Now is the time of year that all that firewood preparation comes in handy.   The house fires burn several hours a day, taking the chill off the evenings.   The cold weather makes cutting hardwoods like maple more difficult.   However, splitting is easier since the frozen wood tends to shatter.

There is one woodcutting opportunity that is only possible at this time of year - cutting fallen trees near the wetland.   I would never do work in environmentally sensitive areas when water is flowing and the wetland would be disturbed.  But at 7 degrees, all moist areas are a solid ice chunk and I can remove the broken branches and fallen trees that are likely to topple in an uncontrolled fashion, causing damage to surrounding flora and fauna.

Part of this woodlot maintenance includes taking down widow makers - dead trees that have fallen onto other trees and are hanging space.    They are called widow makers for a reason.   Do not try this at home!    After 20 years of experience with a chainsaw, I will take down selected widow makers that are at an angle/configuration likely to fall in a predictable way.    Of all the things I do on the farm, taking down these partially fallen trees is the most dangerous activity.   I leave the large ones and the complex ones to professional firms.

On particularly cold and stormy days in January, spending more time indoors to develop the spring planting schedule makes sense.    Last weekend Kathy and I decided that in 2015, we’ll grow cranberry beans, beets, broccoli, carrots, cucumbers, japanese eggplant, mibuna greens, lettuce, pak choi, peas, daikon radishes, spinach, swiss chard, tomatoes, and turnips in the hoop house.    We’ll have 3 major planting dates - March for root vegetables, April for the greens, and May for the cucumbers/tomatoes/peppers/eggplant that we’ll transplant from seeds started indoors in April.  We’ll plant our outdoor squash beds in May.   In June, our new permaculture plants - chestnut trees, pawpaw, and rice (yes, rice) will go into product.   The rice planting is an experiment that will require me to do some engineering creating a rice paddy.

Here’s a handy germination/planting/harvesting guide we use for our planning.   The 2015 hoop house plan is also pictured below.

The joy of winter in New England is that the Spring planting season is that much sweeter.   It’s like hiking in subzero temperatures for 2 days and having your first hot meal.   Food never tasted so good.

As every day passes on the farm, we build less and maintain more.    After this planting season, we’ll have set into motion the trees, perennials, and permaculture ecosystem that can be handed off to the next generation when our time on this earth expires, 30 or 40 years from now.

Thursday, January 8, 2015

Unity Farm Journal - Second Week of January 2015

It’s -6F this morning on the farm.   We expect negative temperatures during the second and third week of January every year, so we have to prepare the animals, infrastructure, and equipment.

The alpacas and dogs have the benefit of a small oil-filled space heater in the barn which raises the internal temperature of the building about 10 degrees.    Protected from the wind, rain, sleet, snow, and ice, the animals curl up together in hay covered stalls, sharing bodily warmth while minimizing heat loss due to convection, conduction, and radiation.   See my previous post on staying warm in New England 

The chickens and guineas have 4 flat panel heaters mounted on the ceiling and walls of the coop.   The coop is dry and the floor is raised off the ground a foot.  Between the heaters and the 80 birds roosting in the space, the temperatures are 20-30 degrees above the ambient air temperature

The ducks generally prefer to be outside, but their duck house has 1 flat panel heater and is protected from the wind.    Today they are all inside their duck house.

The Japanese fountain in the moss garden is shut off - evening moving water freezes at -6F.

The equipment on the farm - the Terex tractor, the commercial mower, the wood splitter, the chainsaw, the blower, and the brush cutter have all been prepped for winter.  I’ve added diesel or gas stabilizer as appropriate to each device and filled their tanks to 90% capacity in an effort to reduce condensation and frozen fuel lines.   I’ve changed the oil in every device.   I’ve cleaned and lubricated every control system.     So far, so good, everything runs.

The humans have to wear multiple layers - a base layer for dryness, a mid layer for warmth and a shell layer for wind protection.   Balaclavas, thick gloves, and insulated boots make me feel more like an alpinist than a farmer, but spending an hour in -6F requires that degree of protection.   Remember, there is no such thing as bad weather, just poor clothing choices.

The root vegetables in the hoop house have all been harvested and the turnips/radishes/beets are stored in the relative warmth of a 35F walk in refrigerator.   All the vegetable beds in the hoop house have thick row covers

Although some might prefer the warmer climates of the Southwest and Southeast this time of year, I relish the seasonal expectations of snow and cold in the winter followed by the gentle warmth of Spring.

Wednesday, January 7, 2015

Looking Forward in 2015

As an eternal optimist, I always look forward to the year ahead and forget the bruises of the year that has passed.

What innovations can we expect in 2015?

In previous posts, I’ve discussed the emergence of FHIR to support standardized query/response APIs for EHRs.  I’ve discussed the “post EHR era”  and the rise of new workflow tools.  I’ve emphasized the importance of social, mobile, analytics and cloud.

How is all of this going to come together in 2015?  

Let me illustrate three examples from recent discussions with industry leaders.

1.  Radiology Clinical Decision Support  - The 2014 Sustainable Growth Rate bill contained completely unrelated mandates for radiology ordering clinical decision support:

(i) IN GENERAL.—The Secretary shall specify qualified clinical decision support mechanisms that could be used by ordering professionals to consult with applicable appropriate use criteria for applicable imaging services.
(ii) CONSULTATION.—The Secretary shall consult with physicians, practitioners, health care technology experts, and other stakeholders in specifying mechanisms under this paragraph.
(iii) INCLUSION OF CERTAIN MECHANISMS.—Mechanisms specified under this paragraph may include any
or all of the following that meet the requirements described in subparagraph (B)(ii):
(I) Use of clinical decision support modules in certified EHR technology (as defined in section 1848(o)(4)).
(II) Use of private sector clinical decision support mechanisms that are independent from certified EHR technology, which may include use of clinical decision support mechanisms available from medical specialty organizations.
(III) Use of a clinical decision support mechanism established by the Secretary.

(i) IN GENERAL.—For purposes of this subsection, a qualified clinical decision support mechanism is a mechanism that the Secretary determines meets the requirements described in clause (ii).
(ii) REQUIREMENTS.—The requirements described in this clause are the following:
(I) The mechanism makes available to the ordering professional applicable appropriate use criteria specified under paragraph (2) and the supporting documentation for the applicable imaging service ordered.
(II) In the case where there is more than one applicable appropriate use criterion specified under such paragraph for an applicable imaging service, the mechanism indicates the criteria that it uses for the service.
(III) The mechanism determines the extent to which an applicable imaging service ordered is consistent with the applicable appropriate use criteria so specified.
(IV) The mechanism generates and provides to the ordering professional a certification or documentation
that documents that the qualified clinical decision support mechanism was consulted by the ordering professional.
(V) The mechanism is updated on a timely basis to reflect revisions to the specification of applicable appropriate use criteria under such paragraph.
(VI) The mechanism meets privacy and security standards under applicable provisions of law.
(VII) The mechanism performs such other functions as specified by the Secretary, which may include a requirement to provide aggregate feedback to the ordering professional.

Current EHRs do not support these requirements.   However, as I wrote about previously, Decision Support Service Providers or third party apps would nicely complement existing EHR ordering features.  However, these services must be integrated into EHR workflow or if separate, offer the convenience of a smartphone user experience.

Cloud or app, the necessary functionality to integrate innovative decision support with an existing EHR would be empowered by FHIR.

2.  Closed loop handoff management

Existing EHRs are suitable for managing individual patients during an individual encounter.  Handoffs such as referral management, care management and integration with post acute providers is still clunky.    FHIR based APIs could enable third party dashboards and workflow engines to ensure referrals are pre-authorized, appointments are kept, and lab results are followed up on.  Just as with novel clinical decision support, I see closed loop handoff management as complementary to existing EHRs and could be offered in either cloud or app formats.

3.  Patient Generated Healthcare Data

As Eric Topol recently posted,  the era of the shared medical record (not an EHR/PHR arbitrary division) is upon us with patients having fluid access to their data for download/view/transmit.   Also devices in the home such as glucometers, FEV1 monitors, pulse ox, scales, and blood pressure cuffs will provide important data to manage patient wellness.   Getting such data into EHRs will require an API and FHIR is the logical bridge between cloud/app sources of patient generated data and EHRs.

In 2015, we’ll have the second FHIR Draft Standard for trial use, a single OAuth implementation guide and early adopters opening their EHRs for a new generation of cloud services and apps.   Direct and CCDA will co-exist for a few years, but eventually, simple JSON-based APIs using REST will eliminate the need for Direct.

Yes, 2015 will bring the Meaningful Use Stage 3 notice of proposed rule making, the ONC 10 year interoperability roadmap and the federal HIT Strategic plan, all of which are important.

But the real quantum leap will be the private sector’s efforts, leveraging FHIR to bring clinicians value-added services and apps (time savings, quality improvement, and efficiency gains) that EHRs have not delivered on their own.

Thursday, January 1, 2015

Unity Farm Journal - A look back at 2014

Just as 2014 was a technological whirlwind, so was life at Unity Farm.

There was new life and death.

My father in law died in November.

One of our ducks died of pneumonia in December.   2 of our guinea fowl were captured by foxes.

Sunny, our new alpaca was born on July 15, 2014 and now weights 50 pounds.   She’s energetic, friendly, and adorable.   We also had one false alpaca pregnancy - Mint, despite appearing pregnant did not give birth

We started the year with 27 guinea fowl and now have 68.   A quick calculation - 34 females x 180 days/year of egg laying x 1 egg/25 hours * 24 hours/day * 10% success rate raising a chick = 587 new guinea fowl in 2015.     Does anyone know about guinea fowl contraception?

We made 160 liters of hard cider, grew 100 pounds of Shitake mushrooms, and harvested 50 pounds of honey.

We kept the dinner table filled with vegetables and the animals had their fill of fresh greens all year.   No pesticides or herbicides were used.   Even the moles/voles/mice were captured humanely and released.

The work of permaculture began with planting 5000 ginseng seeds in the forest.

A mile and half of trails were cut and covered with wood chips.

The farm equipment was well used and maintained every weekend - the chainsaw, blower, brush cutter, wood splitter, commercial mower, pressure washer, and Terex tractor/front loader.

All electrical, plumbing, fence work, painting, and masonry kept Home Depot in business.

The work of building the farm transitioned into the work of running the farm and planning for the future.

As I tell my colleagues, I shovel manure because it is so different from my varied day jobs, although some debate that point.

2014 was filled with joys, sorrows, and a sense that we moved forward.

My daughter is thriving at Tufts, my wife is recovered from her breast cancer and is running the farm during the week, and I’m completely satisfied with the combination of activities that form the fabric of my life.

In 2015, we’ll plant chestnut trees and paw paw bushes, we’ll continue to develop the forest into a rich source of food for the humans and all the creatures nearby, and we’ll keep ourselves mentally/physically fit.

Life is filled with ups and downs.  You never know what tomorrow will bring.   All I ask for is the pursuit of success.  At Unity Farm, that pursuit will never end.