Wednesday, February 5, 2014

Standards for Patient Generated Healthcare Data

At last week's Meaningful Use Workgroup meeting, Leslie Kelly Hall and I reviewed the HIT Standards Committee recommendations for patient generated healthcare data from online applications and devices.

We offered guiding principles for Meaningful Use Stage 3 in general.   Meaningful Use should avoid "certification only" items since requiring engineering in products to support untested workflows with immature standards is unlikely to accelerate progress.   We should only apply standards/certification to those processes where they are needed and useful.

For patient generated data sent from interfaced applications, CCDA is recommended as a container for  types of templates that are well understood (e.g. problems, meds, allergies).   CCDA over existing (Direct, Exchange) and other modes of transport are reasonable ways to get data in and out of EHRs, PHRs, and patient facing applications.

CCDA should not be required as the architecture that integrated applications must use.   The outcome goal is for the entire care team (patient/families/providers) to be able to contribute to a shared medical record and that can be achieved without CCDA in a fully integrated application.  We need to allow for innovation and flexibility in this area and not unduly constrain options for individuals to connect with their care teams in the ways they prefer.

For patient device generated data, we need to support innovation, as the marketplace is still rapidly evolving.

Continua implementation guides (and their underlying IEEE 11073 standards) are directionally appropriate, but ONC needs to align certification with FDA guidance and other regulatory or sub-regulatory policy without constraining the marketplace.

Due to the immaturity of the market,  we need to be flexible regarding incorporation of device data and other remote data sources.  Thus, we do not believe a specific standard should be mandated at this time, just an attestation requirement that some approach has been used successfully.

We are fully supportive of efforts to integrate patient generated healthcare data from applications and devices into provider workflows.    By using the CCDA and encouraging market-based innovative device integration, we believe burden and benefit can be balanced.


Tuesday, February 4, 2014

The Meaningful Use Workgroup Recommendations

Today at the HIT Policy Committee meeting, the Meaningful Use Workgroup will present its recommendations as part of the process leading to a final rule in 2015:

Feb 2014: Draft stage 3 recommendations reviewed with HITPC
March 2014: HITPC approval of stage 3 recommendations
Fall 2014: NPRM for stage 3
1st half 2015: Final Rule for stage 3
Effective: 2017

I presume the regulation writing will follow previous approaches with ONC writing the certification rule and CMS writing the attestation rule.

As I've written about recently, I think it is important to evaluate Meaningful Use Stage 3 from several perspectives including workflow impact, standards readiness, and the tension that such regulations create by prescribing functionality in products, reducing the ability of organizations and vendors to set their own priorities.

The certification criteria noted in the Meaningful Use Workgroup slides are enumerated below and I've added my own discussion questions.  It’s important to assess not only the merits of each of the criteria, but their cumulative effect.   Each hospital and physician office will have to trade-off meeting these requirements instead of doing something else, because few if any providers have the bandwidth to take on more.

In addition to the detailed discussion points below, I suggest that each of the criteria meet a three-part test before being considered for Meaningful Use Stage 3:   1) is there evidence that the specific technology function, if used, would substantially improve the quality, safety, efficiency, or affordability of care? 2) do we believe that the market will not adequately address the requirement on its own 3) will there be sufficient, uniformly available state-level and industry infrastructure in place to make the required technology achievable?.

When I write about such topics, I have to select my words very carefully.   Throughout much of my life, I've been viewed as an edgy innovator.   At this period in my career, some view me as the status quo, resistant to change.  When I propose discussion questions below, I am not taking a position for or against a policy goal.   I'm trying to weigh the cost/benefit of regulation at a time when many stakeholders in healthcare are resource constrained, time bankrupt, and struggling to comply with existing regulations.

I look forward to the open debate of these issues

1.  Clinical Decision Support (CDS)
Ability to track CDS interventions and user responses
Perform age-appropriate maximum daily-dose weight based calculation
Consume external CDS rules

Discussion questions:
a.  Will tracking every intervention and user response, a technically challenging activity, substantially impact healthcare quality/safety, research, or efficiency?
b.  Are standards sufficiently well described/mature to author and exchange externally authored rules?
c.  Must we require that all rules be transmitted or might we allow options such as decision support services in which rules reside in external modules and only questions/answers are exchanged?

2.  Advance Directives
CEHRT has the functionality to store the document in the record and/or include more information about the document (e.g., link to document or instructions regarding where to find the document or where to find more information about it).

Discussion questions:
a.  Given variations in state regulations for advance directives, will we require structured data standards or accept free text/pointers to free text?
b.  Can we eliminate the "OR" since such criteria become an "AND" for developers

3.  EMAR
CEHRT provides the ability to generate and report on discrepancies between what was ordered and what/when/how the medication  was actually administered to use for quality improvement

Discussion questions:
a.  Is tracking every variation/override, a technically challenging activity, a high priority for healthcare quality departments?
b.  Do discrepancies commonly occur and if so, are these discrepancies clinically relevant?

4.  Imaging
For both EPs (menu) and EHs (core) imaging results should be included in the EHR. Access to the images themselves should be available through the EHR (e.g., via a link).

Discussion questions:
a.  To clarify, does this imply a certification criteria to receive electronic radiology results, analogous to electronic lab results?
b.  If so, are the standards for receiving radiology results (including vocabularies for naming radiology tests/procedures) sufficiently mature to support such functionality?

5.  Clinical Documentation
Help the reader understand the origin of any copied text and identify relevant changes made to the original text.  Example method: provide functionality analogous to “track changes” in Microsoft Word™ to make the original source of copied text clear and any subsequent changes made

Discussion questions:
a.  Today, many organizations address copy/paste with policy.   Must we enforce policy with technology?
b.  Given that many applications are web-based and not a "thick client" such as Microsoft Word, there may be significant technical challenges in distinguishing between typing and pasting.   Does the technology exist to support this requirement?

6.  Test Results Tracking
Display abnormal tests
Date complete
Notify when available or not completed
Record date and time results reviewed and by whom
Match results with the order to accurately result each order or detect when not been completed

Discussion questions:
a.  Does this imply implementation of closed loop ordering i.e. require electronic ordering of all tests and not use of an ordering portal, faxing, or order sheets?
b.  Who should be notified via what escalation method when a test is not reviewed or completed?

7.  Device documentation
EPs and EHs should record the FDA Unique Device Identifier (UDI) when patients have devices implanted for each newly implanted device

Discussion questions:
a.  What is the current timeline for UDI implementation in device products?
b.  What will be done with this information once in the EHR i.e. recall workflow?

8.  e-Prescribing
Access medication fill information from pharmacy benefit manger (PBM)
Access Prescription drug monitoring program (PDMP) data in a streamlined way (e.g., sign-in to PDMP system)

Discussion questions:
a.  What is the current state of fill status information standards and their implementation in PBMs/e-prescribing networks?
b.  Which states have a PDMP system and the capacity to support single sign on/patient context sharing?
c.  Are standards available for PDMP integration?

9.  Demographics
CEHRT provides the ability to capture
Patient preferred method of communication
occupation and industry codes
Sexual orientation, gender identity (optional fields)
Disability status
Differentiate between patient reported & medically determined
Communication preferences will be applied to the clinical summary, reminders, and patient education objectives
Providers should have the  ability to select options that are technically feasible for them, these could include:  Email, text, patient portal, telephone, regular mail

Discussion questions:
a.  Do we have appropriate vocabularies for capturing these elements as structured data?
b.  Given current workflows and personnel, do we believe that we can achieve sufficient accuracy in the recording of these elements to support the expected uses of the data?

10.  Record amendment
Provide patients with an easy way to request an amendment to their record online (e.g., offer corrections, additions, or updates to the record)

Discussion questions:
a.  How does this align with current workflow and practice?
b.  What standards are required to support this function i.e. structured approaches to requesting change versus free text i.e. an email request?

11.  Patient Generated Healthcare Data
Menu: Eligible Professionals and Eligible Hospitals receive provider-requested, electronically submitted patient-generated health information through either:
structured or semi-structured questionnaires (e.g., screening questionnaires, medication adherence surveys, intake forms, risk assessment, functional status)
or secure messaging

Discussion questions:
a.  As above, we have to be careful when we use the word "OR" since this  implies "AND" for developers, meaning that all possible variations of functionality must be implemented. What is the minimum functionality required?
b.  Are there standards that constrain the kinds of data submitted i.e. CCDA templates?

12.  Patient Summaries
CEHRT allows provider organizations to configure the summary reports to provide relevant, actionable information related to a visit.

Discussion questions:
a.  How would such rules be authored and what standards would be used to represent knowledge?
b.  What is the definition of relevant and actionable?

13.  Multi-language support
EHRs are capable of providing patient-specific non-English educational materials based on patient preference.  At least one patient receives non-English educational material according to the patient’s language preference

Discussion questions:
a.  Is only one non-English language required as a minimum and not a representative sample based on local populations?  
b.  Are standards  to support multi-lingual retrieval implemented by educational material providers?

14.  Transitions of Care
EPs/EHs/CAHs provide a summary of care record during transitions of care
Types of transitions:
Transfers of care from one site of care to another (e.g.. Hospital to: PCP, hospital, SNF, HHA, home, etc)
Consult (referral) request (e.g., PCP to Specialist;  PCP, SNF to ED) [pertains to EPs only]
Consult result note (e.g. consult note, ER note)
Summary of care may (at the discretion of the provider organization) include, as relevant:
A narrative (synopsis , expectations , results of a consult) [required for all transitions]
Overarching patient goals and/or problem-specific goals
Patient instructions (interventions for care )
Information about known care team members

a.  Are standards available to support these data elements such as patient goals or problem-specific goals?
b.  Are there closed loop workflows required i.e. tracking of completed referrals?

15.  Notifications
Eligible Hospitals and CAHs send electronic notifications of significant healthcare events in a timely manner to known members of the patient’s care team (e.g., the primary care provider, referring provider, or care coordinator) with the patient’s consent if required
Significant events include:
Arrival at an Emergency Department (ED)
Admission to a hospital
Discharge from an ED or hospital
Death

Discussion questions:
a.  Do we have a sufficient vocabulary (NPI, direct address etc.) to identify members of the care team and the means to notify them electronically?
b.  Are standards sufficiently mature to support each of these communications as structured data?

16.  Immunizations
CEHRT functionality provides ability to receive and present a standard set of structured, externally-generated immunization history and capture the act and date of review within the EP/EH practice

Discussion questions:
a.  Are standards sufficiently mature to support query/response of this data?
b.  Do public health departments plan to support this functionality?

17.  Case Reporting
CEHRT is capable of using external knowledge (i.e., CDC/CSTE Reportable Conditions Knowledge Management System) to prompt an end-user when criteria are met for case reporting.   When case reporting criteria are met, CEHRT is capable of recording and maintaining an audit for the date and time of prompt.

CEHRT is capable of using external knowledge to collect standardized case reports (e.g., structured data capture) and preparing a standardized case report (e.g., consolidated CDA) that may be submitted to the state/local jurisdiction and the data/time of submission is available for audit.

a.  Is the CCDA the appropriate standard to support case reporting?
b.  Do state/local jurisdictions plan on implementing such workflows?
c.  Do the appropriate standards and rules for defining reportable conditions exist?

18.  Registry Reporting
Reuse CEHRT data to electronically submit standardized (i.e., data elements, structure and transport mechanisms) reports to one registry
Reporting should use one of the following mechanisms:
Upload information from EHR to registry using standard c-CDA
Leverage national or local networks using federated query technologies

Discussion questions:
a.  Is the CCDA the appropriate standard to support registry reporting?
b.  As with other "OR" criteria, will EHR vendors have to implement upload AND federated query approaches?


Once we answer these questions, we can weigh the impact on clinician workflow, the burden on development resources, and the balance of federal directives versus competing local organizational priorities.

Let the discussion begin!

Thursday, January 30, 2014

Building Unity Farm - Automation Arrives

Over the past few months, I've asked a dozen farmers what automation is best for Unity Farm's 15 acres of woodland management, manure movement, trail maintenance, food storage, and orchard harvesting.    I received thirteen different answers ranging from:

Buy John Deere, Kubota is underpowered

Buy Kubota, John Deere is mostly outsourced

Buy from your closest dealer, service really matters

Don't worry about the dealer, do the service yourself

Buy Agricultural tires, they're absolutely necessary

Buy Industrial tires, since Agricultural tires will wreck your property

Buy a skidsteer/compact track loader for work in mud/snow and on hills.   A tractor is for pulling not pushing

Never buy a skidsteer/compact track loader, they lack flexibility.

What did we buy and why?

I know that at least 11 farmers will disagree with me, but we bought a Terex PT30 Compact Track Loader, pictured above in our orchard.    It weighs 3000 pounds, lifts 950 pounds, yet only has 3 PSI pressure on the ground, leaving the trails and turf untouched.   The machine is the evolution of the ASV RC30 and has an advanced track system that does not slip in mud or snow.  

To make the decision, I test drove several devices.   With the PT30, I was able to move 12 cubic feet of mulch, haul 400 pounds of logs up a 15 degree slope, clear the orchard road of snow, move 500 pounds of rocks, and execute numerous zero turning radius redirections on snow in less than 45 minutes.

Unity Farm is a "compact farm" with one mile of trails that are 5 feet wide.   I really do not want to widen the trails, since their current width gives an intimate feeling of being deep in a forest.    The PT30 works on all our trails and turning around in 5 feet is no problem.  Try that with a tractor.

Unity Farm has many slopes, rocks, roots, gates, and narrow passages around outbuildings.   I was able to drive the Terex through all of the them.

This weekend, I'll move a few thousand pounds of wood and a few cubic yards of mulch around 15 acres.   When I told the salesman that I had already moved 10000 pounds of manure, 10000 pounds of logs, and 10000 pounds of mulch with a wheelbarrow and wagon, he asked "are you nuts?".    The answer to that question could be debated.

Unity Farm was built by hand labor, but now that I'm almost 52 years old, I look forward to the automation as I move thousands of pounds around the property every weekend.

Admittedly that Kubota tractor did look appealing, so I did buy one…for my desk.


Another Unity Farm update.   I lecture frequently at Harvard Business School and write for Harvard Business Review (HBR).    My Harvard students and colleagues often asked me, "why didn't you go to 'B' school"?

They're completely right and I'm going to correct this deficit by enrolling in a nighttime executive  'B' school this semester.

I'll learn about Bee biology, site selection, hive manipulation, four seasons management, honey extraction, and disease control.

In addition to my degrees from Stanford, UCSF, UCLA, Harvard, and MIT, I'll proudly add the 'B' school certificate to my CV this April.

Wednesday, January 29, 2014

Management Lessons Learned from A Game of Thrones

A Game of Thrones is the first novel in A Song of Ice and Fire, a series of high fantasy novels by American author George R. R. Martin.

I rarely watch television, but for Christmas, my wife bought me Season 1 of  Game of Thrones, the HBO series inspired by the novels.  Don't worry, this blog post will not contain any spoilers.

Watching the characters jockey for power and influence reminded me of my experience navigating organizations over the course of my career.   Here are my top lessons learned from the series:

1.  Doing the right thing does not always work

I have strongly believed that the nice guy can finish first and that in the long term those with strength of moral character will triumph.    In Game of Thrones, some of the moral characters are outfoxed by manipulative, cruel, and deceptive characters.   One character notes "When you play the game of thrones, you win or you die."     I have no plans to change my personal philosophy or approach to life, but it is interesting to reflect that some battles cannot be won with honor if your opponents are truly evil.

2.  There should be alignment of authority and responsibility.

One character notes "The man who passes the sentence should swing the sword."   It's easy for management to make decisions when someone else has to implement them.  Over the course of my career, I've been careful to "eat my own dog food" using the products I'm responsible for creating, making hard decisions then executing them, and taking responsibility for consequences that even indirectly result from my actions.   In organizations where there is a disconnect between authority and responsibility, chaos reigns if you lack authority to manage change in your areas of responsibility or if you have authority but are not responsible for your actions.

3.  You need to choose your goals and stick to them.

One of the characters is torn between honor and family.   He does not know whether to stay with his new colleagues (as he as sworn to do) or travel to aid his family in a time of war.   He struggles with the decision and for a time pursues neither goal.   Eventually he chooses honor and is "all in" with that goal, knowing that many others will assist his family and all will be well.

4.  Strategy matters.

In the series, an extremely wealthy family attempts to win a war by being better resourced.   Another family with fewer resources strategically outmaneuvers the wealthy family by building alliances and separating their forces into two contingents, using the element of surprise to achieve victory.     Good planning is just as important as good execution.

5.  You can't predict the future, but you can react to events around you to make the future.

One of the characters is a young and untested leader, willing to grow and make thoughtful decisions as she gains experience.   Events occur around her beyond her control.   She reacts to them calmly and in the best interests of others.  Eventually circumstances change and she seizes the opportunity to move beyond her formal authority, creating loyalty with the informal authority derived from her unique abilities.


We all grow over time and engage in own Game of Thrones at a micro level as we journey through our careers.   Many of the characters in Game of Thrones and in our workplaces are morally ambiguous.   I live each day knowing that I cannot control the behavior of others, only my reaction to it.  Guided by my values, I've been able to achieve little victories in the game of life.

Thursday, January 23, 2014

Building Unity Farm - Winter Fermentations

It's the dead of winter in New England, with new snow on the ground and temperatures near zero.    The animals are clustered together in their barn spaces and heated buckets are keeping their water liquid.

There are many indoor tasks to do on the farm during winter - sharpening chain saw chains and other tools, reorganizing the workbench, ordering seeds, planning for Spring planting (we've been tractor shopping), and nurturing all the fermentations begun in the Fall.

Our fermentations include 3 kinds of cider, mead, cyser (a mixture of cider and honey), vinegar, sourdough,sauerkraut, and fermented pickles.   Here's an overview

1.   Cider, Mead and Cyser

Although we bottled 4 cases of sparking cider in the Fall, we still have 12 cases in the fermenters.    Fermenter #1 is a Champagne Yeast fermentation of 11 different kinds of apples kept at 52F in our mudroom to prevent Malolactic fermentation.  The malic acid in apples is a dicarboxylic acid with a sharpness/crispness that I like in a sparkling cider.  Think of it as the flavor of a green apple.    When I make sparkling cider, I add 6 grams/liter of dextrose at bottling to prime the cider for carbonation.  The malic acid and dextrose create a harmonious flavor that's very refreshing.   I typically have a 16 ounce bottle of sparkling cider with lunch on weekends.   After 2 months of aging, the ph of this cider is 3.75 and the malic acid taste is very notable.

Fermenter #2 is a Champagne Yeast fermentation of 11 different kinds of apples with added Malolactic bacteria culture.   After two months, the ph of this cider is 4.15, much softer and smoother given that most of the malic acid has been converted to lactic acid, which has only a single carboxyl group.  I'll bottle this cider uncarbonated - as still cider.   Malolactic fermentation changes the flavor a bit, adding the kind of butteriness you taste in most Chardonnays.

Fermenter #3 is a Champagne Yeast fermentation  of 11 different kinds of apples with added Malolactic bacteria culture.   The yeast has exhausted many of the nutrients in the cider due to a Keeving process  I used during the initial fermentation.  It's fermenting very slowly and I believe I will end up with a smooth cider with a small amount of residual sweetness.  I'll bottle this cider uncarbonated as well.   The ph of this Cider is 4.07.

The taste among the three is remarkably different and we'll see which one is best once I bottle them in the Spring.

The mead and cyser fermentations continue.   At the first racking, the specific gravity of the mead decreased from 1.090 to 1.030, yielding 8% alcohol.    The specific gravity of the cyser decreased from 1.085 to 1.010, yielding 10% alcohol.   We'll continue fermentation until the Spring and bottle them uncarbonated in 375ml clear wine bottles once fully fermented to a specific gravity of 1.000.

2.  Apple Cider vinegar

I separated 20 liters of hard cider from the other fermenting batches, added mother of vinegar  and stored it in the basement, open to the air.   When it is finished, the titratable acidity will be 5%.  It's currently at 2% and has a remarkable flavor without being overpowering.


3. Sourdough
We use the King Arthur Starter and keep buckets of active sourdough growing in our mudroom.

4.  Sauerkraut
We use a 5 liter Harsch crock and weights with the following recipe

3kg of cabbage
15 grams of salt

Remove wilted outer leaves of cabbage head, and the stalk. Shred cabbage.

Layer the cabbage, sprinkle some salt then press down with a fist until juice appears. Repeat until pot is full.

Lay on the weights and if there is not enough juice, add cooled boiled salt water (15gm salt per liter ratio)

Close lid, then add plain water to the rim (water trap)

Leave pot at room temperature for 3 days until you hear some bubbling.

Move to a cooler room for 4-6 weeks

Move into large Ball jars in the refrigerator.   Eat within a month.


5. Fermented Pickles

We use a food grade 2 gallon bucket and a plate on top as a weight
2 pounds freshly picked firm, unwaxed, bumpy pickling cucumbers, often called Kirby
2 cloves spring garlic, sliced thin
1 dill flower, or 5 sprigs fresh dill or 1 teaspoon dill seed
1/2 teaspoon coriander seed
1/2 jalapeño, seeded and slivered
2 tablespoons salt

Soak cucumbers for 30 minutes in a bowl filled with ice water to loosen any dirt. Slice the blossom end off each cucumber, which is opposite the stem end. If you aren’t sure which end is which, slice a little off each. Cut cucumbers into spears or chunks, if desired.

Pack cucumbers into one or two clean quart jars. Tuck in garlic, dill, coriander and jalapeño, if using.

Add salt to two cups boiling water. Stir until dissolved. Add two cups of ice (made with filtered water if yours is chlorinated). Stir well until the ice has melted and the brine is cool. Pour brine into jars, covering cucumbers.

Loosely cap jars and place in a bowl or pan because the jars may leak during fermentation.

Leave pickles on the counter to ferment. The brine will bubble lazily and become cloudy. Taste after 3 days, leaving on the counter another day or two if you want your pickles more sour, or refrigerating if they’re ready. They keep a month in the refrigerator.


It's time to put another log on the fire and listen to the subtle bubbling of our winter fermentations.




Wednesday, January 22, 2014

Advice to the New National Coordinator

Karen DeSalvo started as the new National Coordinator for Healthcare Information Technology on January 13, 2014.   After my brief discussion with her last week, I can already tell she's a good listener, aware of the issues, and is passionate about using healthcare IT as a tool to improve population health.  

What advice would I give her, given the current state of healthcare IT stakeholders?

1.  Rethink the Certification Program -  With a new National Coordinator, we have an opportunity to redesign certification. As I've written about previously some of the 2014 Certification test procedures have negatively impacted the healthcare IT industry by being overly prescriptive and by requiring functionality/workflows that are unlikely to be used in the real world.   One of the most negative aspects of 2014 certification is the concept of "certification only".   No actual clinical use or attestation is required but software must be engineered to incorporate standards/processes which are not yet mature.   An example is the "transmit" portion of the view/download/transmit patient/family engagement requirements.   There is not yet an ecosystem for patients to "transmit" using CCDA and Direct, yet vendors are required to implement complex functionality that few can use.   I completely support the idea of "transmit", but it should have waited until the ecosystem was mature enough to make it an attestation requirement.  Another example is the use of QRDA I and QRDA III for quality reporting.   CMS cannot yet receive such files but EHRs must send them in order to be certified.   The result of this certification burden is a delay in 2014 certified product availability.   Certification should focus on rigorous interoperability testing, using mature standards, in practical use cases, supported by the evidence and experience.

2.  Evaluate the collective timelines of Meaningful Use, ICD10-CM, ACA and the HIPAA Omnibus Rule - Thousands of pages of regulations are hitting the industry at the same time and it's clear that like healthcare.gov, haste will make waste.   My suggestion - extend Meaningful Use Stage 2 Year One attestation by 6-12 months (not just delay Stage 3 a year as has already been done) to enable clinicians to install certified software, redesign workflows, be properly trained, and educate their patients about the new functionality available.   I realize this may be a regulatory leap, but I've seen new rule making done as corrective action in the past.  Although I believe ICD10-CM requires more testing (the CMS planned March testing is not enough) and most applications will not contain the clinical documentation improvement features needed for clinicians to adequately justify the new codes, most hospitals have put so much time and resources into ICD-10-CM projects that they cannot afford to extend the project beyond October 1.  For ACA, re-evaluate quality measure submission requirements per point #4 below.   For the HIPAA Omnibus Rule, rethink the accounting of disclosures scope and timing.

3.  Declare victory for Meaningful Use -  Stage 1 of Meaningful Use was a phenomenal success.   Adoption rates of good EHRs by hospitals and eligible professionals has tripled.   Public health reporting and interoperability are accelerating.   Awareness of security issues has markedly improved.   Stage 1 was seen as a tide floating all boats.   Stage 2 was greeted with less excitement.   It exceeded the capacity of many organizations from a technology, policy, and workflow perspective.  It has been described as a burden that has slowed innovation, consumed industry resources, and co-opted local agendas for quality improvement projects.   However, it has many benefits and those gains can be captured with enough time.   By the end of Meaningful Use Stage 2, hospitals and eligible professionals will have reached a breaking point in their capacity to absorb regulatory burdens, so we have to progress beyond 2017 very thoughtfully.   If our policy goals are outcomes based, then we should offer a Stage 3 regulation which enables organizations to qualify for incentives if outcomes are achieved using IT as an enabler.   We should not prescribe specific functionality for the EHR other than interoperability and security.  As noted in point #1, focusing on certification and attestation for interoperability is reasonable as long as there are no "certification only" functions mandated.     We should eliminate penalties for non-compliance with Stage 3 and return EHR innovation to customers and vendors.   Meaningful Use will have succeeded if we capture the gains of Stage 1 and 2, then focus on Stage 3 incentives that drive us to better outcomes, rather than penalizing providers for not checking more attestation boxes.

4.  Fund pilots and research -  We are on the cusp of a sea change in interoperability, population management, and clinical decision support.   CCD led to CCDA which leads to FHIR for content summary exchange.    The Direct protocol will evolve to a RESTful interface using OAuth/OpenID for trust fabric creation.   However, we're not going to make the move to FHIR and REST unless pilots (followed by agile development of implementation guides) are funded to enable incremental progress.   FHIR is too new and REST has too many industry skeptics.   The pilots will create a tipping point which mitigates risk and enables progress.   Also, two of the great challenges in informatics - automated quality measures (QueryHealth and HQMF) and nationally curated decision support (Health eDecisions) would benefit from pilots.   In point #1 I noted that we need mature standards but at present our quality measurement and decision support standards are immature.   If we pilot them and revise them, we'll mitigate risk and can consider the use of quality and decision support standards which are optimized for purpose in future interoperability certification.

5.  Continue the ONC convening function for standards, privacy/security, and hearings to capture lessons learned about adoption/implementation -  ONC provides a very important and unique convening function in which issues can be discussed by multiple stakeholders.   There will be an ongoing need for standards selection and revision, bridging the work of standards development organizations and clinical stakeholders.   Privacy and security policy is informed and improved through national debate of the issues.   Evaluating the successes and shortcomings of the EHR related regulations is important to future refinement.   I suggest that ONC/CMS limit their regulatory focus on Meaningful Use requirements related to mature interoperability standards and privacy/security (as noted above), and focus much more on bridging gaps in five key areas:  a)  ONC versus CMS (certification versus attestation); b)  HHS versus CMS (disparate quality measure and other reporting requirements within the HHS domain); c) the government versus market (vendors and providers); d) vendors versus providers; and e)  providers versus patients.  In practical terms, this would focus less on a core belief that 'all EHRs should do X, Y and Z' to a focus on 'given what we are learning about an ever-evolving market (e.g., new payment models, new delivery models such as Patient Centered Medical Home, new technologies, new patient engagement models, etc), what EHR interoperability needs, quality measures, and privacy/security safeguards are needed.'

It's a fragile time at ONC when the excitement of the ARRA/HITECH funded grant programs has passed, many people have departed, and Congress is wary of IT projects in general.

Karen is the right person for the job at this time in history, just as her predecessors were the right people for their eras.   She can regain the trust of Congress, make midcourse corrections to the Meaningful Use program, and balance the burden/benefit on stakeholders.   If she can rebuild a city's health system after Katrina, she can polish those elements of the ONC strategy that experience in the marketplace has deemed to be necessary.


Thursday, January 16, 2014

Building Unity Farm - The Sounds of Unity Farm

Since moving to the farm in April of 2012, I've posted many pictures of our efforts to create a working farm in Sherborn, Massachusetts.   Although it's winter, the farm still bustles with activity.   To give you a sense of what I experience every morning as I walk through the barnyard tending to the creatures, I carried an Olympus USB audio recorder with me on a recent morning.

On the front of the farmhouse we have a rain chain in lieu of gutters that drains into a cistern to capture water.    It was raining during my recording you'll hear my walk from farm house, past the rain chain, to feed the guinea hens and ducks.

After feeding the ducks and guineas I sat with the chickens for a few minutes and fed them scratch grains.   Our two roosters decided to compare their voices.

The duck pond was thawing as the temperatures warmed and I spent a moment clearing the ice so that the birds could enjoy open flowing water.

I brought fresh lettuce from the hoop house to the birds  and placed it in a large rubber bowl so all the animals could enjoy a taste of summer during the winter.   The guineas squawked with joy as they crunched the leaves.

The northern border of Unity Farm is mixed forest and wetlands.   The western border is the Dowse apple orchard.  The southern border is another farm.   The eastern border is the CSX rail line (map below) for slow moving freight trains that travel between Framingham and Foxboro.   At 7am, 12:30pm, and 2:30pm and 11:30pm, we hear the gentle rumble of a freight train in the distance, 10 acres away through our forest.   Here's what the morning train sounds like from the barn.



Every season brings new sights and sounds on the farm.  This spring many migratory birds will return and nest at Unity Farm.   This summer, we'll experience the birth of several baby alpaca.   The Fall brings the rustle of falling leaves.   More sound posts to come!