Dispatch from China

I’m in China this week meeting with government officials, hospital leaders and academics to review the policy lessons learned from HITECH, ACA, and the HIPAA Omnibus rule.

I started Monday in Shanghai, meeting with Huashan Hospital to discuss their clinical data repository and healthcare information exchange plans.   For them, “big data” analytics are a core focus for the next year as they integrate operations in their North, East and West Shanghai locations.   Their "systemness" challenges are very similar to those facing ACOs in the United States.

Tuesday and Wednesday included a trip to Hangzhou, the “Silicon Valley” of China, home to Alibaba.com, China’s version of eBay and Amazon.    I met with the mayor to discuss EHR and HIE demonstration projects, accelerated by the deep technological talent pool available in Hangzhou.

Tonight, I will fly to Dalian in preparation for two days of meetings and keynotes at CHIMA, the Chinese Hospital Information Management Association  Congress, similar to HIMSS.

Thursday’s keynote will reflect on the state of healthcare IT and HIE adoption in the United States, providing statistics about our progress during the HITECH years and offering case studies of US regions which have success stories.

Friday’s keynote will describe the big challenges we face in the next phase of our US work from 2014-2017 including identifying lessons learned from Meaningful Use Stage 2, finalizing Meaningful Use Stage 3, building analytics in support of ACOs, securing cloud services, and embracing mobile including family/patient engagement apps.

On Saturday I will meet with several Ministry of Health officials to discuss nationwide standards and policy for China, then fly back to Boston.

I try very hard to limit travel and often speak virtually these days.   In China, like many Asian countries, physical presence is important.    My role as Harvard Professor includes volunteering my time to share my experiences, encouraging others avoid my failures, and mentoring the next generation of healthcare leaders worldwide.  The 12 hour time difference in Asia enables me to work 12 hours in China then work 12 hours in Boston.  

I turn 52 this week and thus far, the balance of life as a CIO, professor, husband, father, and farmer seems to be working.    I can tell that the road warrior wear and tear, including 12 hour time changes, is likely to become more difficult.  For today (and as long as I can) I will live each day to the edge of my capabilities.

CMS Proposed Rule Adds Flexibility to Meaningful Use in 2014

Although I'm in China at the moment and it's 5am, the news from Washington is so important that I had to share it immediately.

ONC and CMS have listened to the testimony offered by many stakeholders and have proposed a rule that elegantly allows Meaningful Use attestation flexibility for 2014 while keeping the momentum going for product upgrades and 2015 attestation.

You'll find the rule here

It wisely states "A provider’s ability to fully implement all of the functionality of 2014 Edition CEHRT may be limited by the availability and timing of product installation, deployment of new processes and workflows, and employee training."

The options available are summarized in the table below.

Unity Farm Journal - Third Week of May 2014

Last Fall, Kathy and I inoculated 165 logs with 11 different subtypes of Shitake.   The typical “spawn run” of Shitake is 1 year, so we expected our first early flushes of mushrooms in October.  Imagine my surprise when I found that 5 subtypes fruited last weekend.    Here’s a picture of WR46, one subtype, with my boot in the background.   We carefully harvested all the mushrooms and we’ll prepare the fresh mushrooms to compare and contrast their flavors and textures.

I’m in China from May 18-24, but we’ve prepared our new outdoor mushroom beds for inoculation of additional almond mushrooms when I return memorial day weekend.   This warmth loving mushroom is already growing in our hoop house which is typically 80 degrees+ this time of year.     In New England, we’ve been careful to avoid outdoor planting before Memorial Day given the possibility of freeze.   Almond mushrooms cannot survive below 35F

We’ve built “fodder boxes” - hardware cloth covered 4’ x 8’ frames to protect newly planted grass from ducks, chickens and guinea fowl.    Now that we’ve finished the grading around the barnyard, we’ve planted a tough, drought resistant fescue.   The fodder boxes will enable us to “open the salad bar” when the grass is mature enough to survive a poultry feast.

Although I have a brief May trip to China and a few days in Japan in July, I have limited my international travel to ensure I have time for all my varied life responsibilities.   Rather than bring the family to Asia, we’ve worked to bring Asia to the family, turning a portion of Unity Farm into a moss covered Zen garden.   This year marks my 30th wedding anniversary.   For my 15th anniversary, I transported a 500 pound granite stone bench from a quarry in Western Massachusetts to our backyard in Wellesley.   Now that same bench and a Japanese lantern are the focal points of the Zen garden, surrounded by native cedars and rhododendrons.  

The trail signs arrived to complete the bridges I built for the vernal pond trail, cattail hollow trail, and forget-me-not glen.     I look forward to the day when visitors can explore the hidden wonders of the 15 acres

Finally, I’ve finished clearing the 10 fallen poplars that were knocked down during hurricane Sandy.    The wood will not leave the property - it will soon become wood chips that will be returned to the forest trails.

The JASON Report

On 4/09/2014, AHRQ released the JASON report, facilitated by Mitre.   JASON is an independent group of scientists who advise the United States government on matters of science and technology.

The intent of the report is to make recommendations for a new healthcare IT architecture to accelerate interoperability.

When reading the report, it’s best to focus on the big ideas and ask how those concepts can be aligned with a a stepwise multi-year approach to address technology and policy challenges.

1.  Like the PCAST report, which heavily inspired the JASON report, there is a stated need for a common mark-up language for healthcare including controlled vocabularies.    Today, that language is the CCDA and the vocabularies are available from the National Library of Medicine’s Value Set Authority Center.   In the next few years, it’s likely that  Fast Health Interoperable Resources (FHIR) will become the new markup language, given that it is simpler to implement and parse than the existing CCDA.   The work to refine FHIR is already in progress at HL7 and the HIT Standards Committee.   The report distinguishes between the medical “chart” or “record” data verses structured data storage.      There is valuable research work in progress and emerging products to leverage natural language processing, turning unstructured notes into actionable knowledge.

2.  The report notes the importance of application programming interfaces (APIs) to support architectures that are agnostic as to the type, scale, platform, and storage location of the data.   In Meaningful Use Stage 2, the interoperability focus is on push models - sending data from one EHR to another EHR as structured, importable information.   I agree that our next areas of focus should be query/response.  API is  a very general term and Massachusetts  (MassHIWay) has created the necessary RESTful and SOAP approaches to support populating a master patient index, consent/privacy preferences, and real time query of healthcare data.  The MassHIWay is very well aligned with the first phase architecture that Jason recommends as a good starting point to accommodate real-world constraints, per the graphic below.

3.  The report suggests that all data be encrypted at rest and in motion.   Meaningful Use already requires encryption of data in motion.   HIPAA requires compensating controls for data at rest, one of which is encryption of client devices.

4.  The report describes separation of key management from data management.   The Direct protocol, which is a required part of Meaningful Use Stage 2, implements certificate management to ensure security and data integrity from point of data origin to point of use.   The report describes highly granular consent, enforced with certificates.   That principle is similar to the S&I framework Data Segmentation for Privacy work, which has been codified in HL7 standards.

5.  The report notes that data should be surrounded with corresponding metadata, context, and provenance information.   EHRs typically include time/date stamps, authorship information, and other contextual information with most transactions, so the suggestion is reasonable.

6.  The report suggests that EHR data be represented as discrete data elements (atomic data) with associated metadata.   The Meaningful Use Common Data set for Stage 2 already requires that.

7.  The report  recommends adoption of the “robustness principle”: be liberal in what you accept and conservative in what you send.   The 2015 Notice of Proposed Rulemaking suggests that certification in 2015 include testing of that principle.

8.  The report identifies a need to support clinical trials and clinical research while also protecting patient privacy.    The I2B2 project, which has been further generalized by the ONC QueryHealth project, is a good start.

My implementation suggestions for ONC and the Standards Committee to implement JASON recommendations are summarized as

1.  Evolve CCDA transition of care documents to FHIR
2.  Replace Direct with a RESTful approach for “pushing” records
3.  Adopt a query/response RESTful approach for “pulling” records
4.  Adopt a simple HL7 2.x admit/discharge/transfer message that records patient consent preferences for disclosing data from an institution
5.  Adopt I2B2 to support a learning healthcare system

I want to thank the JASON group for re-emphasizing the importance of the trajectory we’re already on, identifying milestones for success we can use to evaluate our progress.

Unity Farm Journal - Second Week of May 2014

Last weekend was picture perfect spring weather - 50’s and 60’s with slight rain.   The forest is leafing out and the flowers are blooming including the weeping cherry.

Our “vole attack” of last week has a followup.   Although we removed an adult vole from the hoop house, we did not consider the possibility that she had hidden offspring.   Over the course of the week, we found 5 young voles - timid enough that we could pick them up by hand.   I reunited mom and babies in a new home 1000 feet from the hoop house.   Now that we have fully protected our planting areas with hardware cloth, I hope our vole adventure has come to an end.   The lettuce is growing much faster without the voles.

On Saturday, I discovered a slightly different rodent problem.   The Revolutionary War-era rock wall in our orchard has become the favorite tanning spot for a marmot - the New England Groundhog.  He's shy so I do not yet have pictures other than the burrow.   It will be interesting to see what happens when an 8 pound rodent begins grazing in the orchard.

A coyote also visited the farm during the day on Saturday.  The guinea fowl all began alarming and I ran over to the poultry hard to check out the threat.    A very healthy looking coyote looked at me then slowly trotted away.    It’s normal for coyotes to hunt during the day while raising their pups in  spring and summer.    Since our orchard gates are purposely constructed to allow foxes and coyotes to hunt rodents, maybe they'll feed on the voles and not on the chickens!

We prepared a series of raised beds with leaf compost, chicken manure compost and alpaca manure compost for inoculation with Agaricus Subrufescens, the almond mushroom.   Using a the end of a rake, I punched 6 inch holes in the compost every 12 inches and filled them with Agaricus impregnated sawdust.    I then raked the bed to ensure a 3-4 inch covering of compost over the spawn.   During the heat of summer we should see fruiting and it will be interesting to document the growth patterns in different types of compost.

On Sunday we weighed every animal on the farm, cleaned ears/eyes, trimmed toenails, and gave anti-parasitic inoculations.    Memorial Day weekend is scheduled for shearing - about 10 pounds of fiber from each alpaca will be carefully trimmed, cleaned and spun into yarn.   The alpaca are enjoying the new orchard grasses of springtime.

Finally last Sunday, we installed a 30 foot windbreak on the north side of the bee yard.   Weather in New England has been increasingly severe with 40+ mile per hour winds.   We want to protect the bees and the hives from Northeast storms.

Next weekend  we will install trail signs on the Vernal Pool/Cattail Hollow/Forget-Me-Not Glen trails, finishing the initial paths that make all 15 acres accessible.    I'll add a few more Agaricus mushroom beds, haul a few tons of poplar that fell during Hurricane Sandy, split wood, and prepare an area behind the house for new grass planting, protecting it with specially made fodder boxes that keep the ducks and chickens from eating the early sprouts.    The following weekend I head to China, so my farm activities will slow for a few days.

The Food and Drug Administration Safety and Innovation Act (FDASIA) Report

On April 3, HHS released the FDASIA report which presents a risk based framework for evaluating the safety of innovative devices and applications.

In issuing the report, the FDA took a very balanced view and did not expand its regulatory scope.    It defines the world of medical devices and applications as

1.  Administrative - i.e. something that reminds you about an appointment
2.  Wellness - i.e. something that reminds you to exercise, stay hydrated, and eat right
3.  Medical Device - i.e. something that measures a body signal and initiates a specific diagnosis or treatment.

#1 is not subject to regulation.   #2 will have oversight by ONC but no regulation.  #3 will be regulated by the FDA.

The FDA makes clear it will not focus on #2 and it will not regulate cell phones/smart phones because a mobile medical application can be operated on one.   Devices that perform wellness management will not require registration or product listing.

Given the responsibilities assigned to ONC, it’s likely ONC will have to add staff with device and mHealth expertise.   The language in the report suggests that ONC’s standards and best practices for wellness applications will be voluntary.

It’s always a challenge to balance innovation and government regulation.  The idea of harm reduction through a risk-based framework makes great sense.

Unity Farm Journal - First Week of May 2014

Temperatures in New England are warming, with most days in the 50’s and nights in the 40’s.

Last weekend was spent installing 50,000 bees in new bee hives.   The process of package installation is straightforward.    First, the queen, who is kept in a separate small cage, is placed in the hive.    Below is a picture of preparing the queen cage for insertion.     Next 10,000 bees are gently poured into the hive.   Below is a photo of the process.    50,000 bees moved, no stings.   A great day.

Our bees are actively gathering pollen and nectar from the forests surrounding the farm and adjacent fields/orchards.    We want to support our bees with plants that bloom throughout the seasons.   We inventoried the major native and cultivated plants on the farm, evaluating their value to bees as food sources as well as their timing.   Barbara Keene Briggs of Tree Specialists Inc. created this chart to illustrate gaps in pollen/nectar flow and plants needed to fill those gaps.    This weekend, we planted the bee yard and you’ll see the young plants in the photo below.

In last week’s post, I mentioned a new trail that I’ve built, the Forget-me-not Glen trail with it’s 60 foot boardwalk.   It’s finished and below is a view from an island in the tream.

The vegetables in the hoop house continue to grow now that we have installed hardware cloth to eliminate vole and chipmunk access.

Kathy and I moved a ton of fallen poplar to our latest mushroom area and after 108 chain saw cuts,  inoculated the stacks of wood with 6 subtypes of Oyster mushroom.    For the next three months, they’ll incubate in black plastic bags for their “spore run”.   We’ll have 100+ pounds of oyster mushrooms this Fall, which we’ll sell at a local farmer’s market.

We cultivate Shitake, Oyster and Lion’s Mane mushrooms in our 5 mushroom yards.   Over the weekend, we loaded a few hundred pounds of chicken manure compost into raised beds and inoculated with Agaricus subrufescens, the Almond agaricus with a rich amaretto flavor.

Next weekend will be devoted to trail maintenance and herd health, weighing and examining all the creatures of Unity Farm.