More Meaningful Use Stage 2 Highlights

Yesterday, I posted a few of the innovative aspects of the ONC Final Rule.

Today, here's my top 10 list of the bolder aspects of the final rule.

1. Hospital labs must provide results to community clinicians in structured electronic format - paper and fax goes away.

2.  A requirement for cross-vendor transition of care health information exchange will force functional interoperability by requiring disparate applications to use common content, vocabulary and transmission standards over the wire.

3. "Incorporate" data after receipt of structured documents combined with a requirement for decision support on this data means that healthcare information exchange will become actionable. Structured medication, allergy and problem list data from outside applications will be reconciled, resulting in a patient centered electronic medical home that improves quality, safety, and efficiency.

4. Coded structured data with one set of standards per domain of medicine - problems, meds, labs, smoking status - will be foundational for innovations in decision support and patient education.

5. Backwards compatibility with CCR and CCD so that next generation approaches using consolidated CDA can evolve while still maintaining the ability to receive the older summary formats.

6. Identity reconciliation as a component of information reconciliation.   The rule notes "upon receipt of a transition of care/referral summary is the appropriate point at which to verify that the transition of care/referral summary is being attributed to the correct patient."   This will require vendors to implement novel patient matching techniques.

7.  Patient online access to audit logs of their own view/download/transmit activities.  Innovative yes, but it's doable and a great aid to help ensure patient privacy preferences are respected.

8. Quality measures which are based on EHR data elements and can be computed in real time, with standards to report patient level and aggregate data.  The rule notes "we have adopted both the HL7 QRDA Category I standard to support a patient level data submission approach and HL7 QRDA Category III to support an aggregate level data submission approach."

9. Data portability via a summary export capability that enables transition from one EHR to another.  This eliminates vendor lock in and empowers the market to evolve more rapidly.

10. ICD 10 was included in the final rule for encounter diagnoses.   This was important given that the October 1, 2014 ICD-10 adoption deadline was finalized this morning 

Each of these 10 items provides potential for innovation by start up companies that could fill functional gaps in enterprise vendor products.   The new certification approach will make such gap filling easier than with stage 1.

Also today the folks at the Advisory Board published booked versions of the rules

ONC

CMS

It's not only the most exciting time to be in healthcare IT, but with the requirements above, the most exciting time to be an innovator creating new functionality that does not exist in the marketplace today.

Meaningful Use Stage 2 Rules Released

The Office of the National Coordinator for Health IT (ONC) and The Centers for Medicare & Medicaid Services (CMS) today released final requirements for Stage 2 Electronic Health Records Incentive programs. The regulations can be found here:
CMS
ONC

A fact sheet on CMS's final rule is available here.

A fact sheet on ONC's standards and certification criteria final rule is available here.

The vocabulary, transport, and content standards in the ONC Final rule align perfectly with previous recommendations from the HIT Standards Committee. A few highlights of interest from my initial reading:

1. SMTP is the required transport standard for all certified EHRs and has been included in the Base EHR definition, meaning that all EHR technology used by EPs, EHs, and CAHs and that meets the CEHRT definition will, at a minimum, be capable of SMTP-based exchange.

There are two optional approaches for the transitions of care certification criteria SMTP/XDR and XDR/SOAP. The specific language reads

"The Secretary adopts the following transport standards:
(a) Standard. ONC Applicability Statement for Secure Health Transport (incorporated by
reference in § 170.299). .
(b) Standard. ONC XDR and XDM for Direct Messaging Specification (incorporated by
reference in § 170.299).
(c) Standard. ONC Transport and Security Specification (incorporated by reference in §
170.299).

EHR technology must be able to electronically receive transition of care/referral summaries in accordance with:
(A) The standard specified in § 170.202(a).
(B) Optional. The standards specified in § 170.202(a) and (b).
(C) Optional. The standards specified in § 170.202(b) and (c).

To permit additional flexibility and options for EHR technology developers to provide their customers with EHR technology that has been certified to support an EP, EH, or CAH’s achievement of the “transitions of care” MU objective and associated measure, we have adopted two optional certification approaches for transport standards. For each option, EHR technology would need to demonstrate its compliance with both of the identified specifications in that option in order to be certified to the option.
• The first option would permit EHR technology to be certified as being in compliance with our original proposal: certification to both the Applicability Statement for Secure Health Transport specification and the XDR and XDM for Direct Messaging specification.
• The second option would permit EHR technology to be certified to: the Simple Object Access Protocol (SOAP)-Based Secure Transport Requirements Traceability Matrix (RTM) version 1.0 standard and the XDR and XDM for Direct Messaging specification."


2. Electronic notes must be searchable

"Enable a user to electronically record, change, access, and search electronic notes."

I look forward to vendor implementations of searching free text - will they use simply keyword indexing or more innovative natural language processing techniques that enables text to be search with context as I wrote in this blog post.

3. EHRs must support display of image results, although this could be accomplished via a single sign on link to a PACS system

"Image results. Electronically indicate to a user the availability of a patient’s images and narrative interpretations (relating to the radiographic or other diagnostic test(s)) and enable electronic access to such images and narrative interpretations."

4. Encryption is required for EHR data stored locally on client devices - this refers to caches and local databases created by the application and not a user saving a file or doing a screen print.

"Record the encryption status (enabled or disabled) of electronic health information locally stored on end-user devices by EHR technology in accordance with the standard specified in § 170.210(e)(3) unless the EHR technology prevents electronic health information from being locally stored on end-user devices (see 170.314(d)(7) of this section)."

Here's a summary of the intent

5. Care Coordination data must be receivable using the Direct protocol and incorporated in structured form.

"(B) Data incorporation. Electronically incorporate the following data expressed according to the specified standard(s):
(1) Medications. At a minimum, the version of the standard specified in § 170.207(d)(2); (2) Problems. At a minimum, the version of the standard specified in § 170.207(a)(3); (3) Medication allergies. At a minimum, the version of the standard specified in § 170.207(d)(2)."


6. Health Information Exchange with Patients is required using the Direct protocol

"EHR technology must provide patients (and their authorized representatives) with an online means to view, download, and transmit to a 3rd party the data specified below.

Transmit to third party. (1) Electronically transmit the ambulatory summary or inpatient summary (as applicable to the EHR technology setting for which certification is requested) created in paragraph (e)(1)(i)(B)(1) of this section in accordance with the standard specified in § 170.202(a).
(2) Inpatient setting only. Electronically transmit transition of care/referral summaries (as a result of a transition of care/referral) selected by the patient (or their authorized representative) in accordance with the standard specified in § 170.202(a)."

I'll write more over the next few days. I look forward to industry reaction as to the difficulty of implementing some of the more novel workflows.

The Golden Spike Planning Session

Today, nine organizations interested in early adoption of the Statewide HIE met to plan the final details of the October 15, 2012 go live.

We explored in the depth the details of the Direct standard and its supporting components including S/MIME clients/servers, XDR (SOAP), Webmail (Secure web-based messaging), use of gateway appliances that act as middleware between existing EHRs and Direct compliant HISPs, certificate lookup via web services/DNS, and provider directory standards.

We reviewed these slides

Here's what we decided:

All our early participants - Partners, BIDMC, Childrens, Baystate, Atrius, Network Health, Holyoke, Vanguard,  and a solo practioner declared that the gateway appliance or XDR would meet their needs.

The gateway appliance supports simple EHR integration via file drop, FTP, XDR, HL7 via TCP, West Services and REST.    The XDR approach enables automated routing to XDR or SMTP recipients - the Massachusetts HIE provider directory query will return the XDR address of XDR capable recipients or the state's Direct gateway address for XDR to SMTP translation and forwarding for those organizations which can only receive SMTP.   This moves the complexity out of the EHRs and into the HISP for protocol conversion and routing services.

We reviewed the draft HIE participation agreement and received broad support for the document and its supporting addendum.

Next, we reviewed pricing.  The principles we discussed included

*All participants should pay some subscription fee to cover the private sector share of operating costs, but prices should be tiered like a progressive income tax - wealthier organizations pay more to reduce the burden on organizations with fewer resources
*Participants will pay only for the service level they consume
*Fees will be adjusted periodically as circumstances change, recognizing that the first year costs are an estimate

Finally we discussed the effort to ensure the 14 vendors which constitute 90% of the Massachusetts marketplace will be connected to the HIE as needed.

A very exciting time for HIE - the energy of the early adopter stakeholders is palpable. I'll provide several updates over the next two months as we countdown the days until go live.

The Alpacas Arrive at Unity Farm

For more photos, see our Unity Farm Alpacas Facebook site.

Joyful Chaos

My daughter recently returned from a month long stay in Long Island to rejoin Kathy and me at the farm we've been creating since May.   She walked the barn, the paddocks, the new pasture,  the new buildings and the new trails, then concluded "there's so much happiness and energy infused into a whirlwind of change - it's joyful chaos."

In past personal blogs about our cancer journey, I've explained the "why" - looking forward to a vision of a bucolic future made the six months of cancer treatment a lot more tolerable.

Ive never explained the "how".     In a new series of Thursday blogs, beginning today, I'll recount what we've done and what we're doing to turn 15 acres of Sherborn, Massachusetts into a productive working farm providing a non-stressful environment numerous animals and a nurturing ecosystem for a bountiful fruit/vegetable harvest.

The property we purchased in April 2012 has all the right ingredients - former pastureland filled with 1700's rock walls, flat sunny well drained soil with generous sun exposure, forest, a meadow, and a stream/wildflower wetland.

Over the past hundred years, the pastures have filled with second growth trees - pines, oaks, and black birch.      The rock walls have been lost in a sea of bittersweet, wild grape, and poison ivy.

Our first task was re-open the pastures.    We cleared over 50 trees including numerous invasive/non-native plans.   We used an expert tree contractor for the large trees and for the smaller trees I used a Stihl MS290 chainsaw, a Gransfors Bruks splinting maul/Swedish forest axe, and a steel farm  push cart capable of hauling 800 pounds.

Our next task was to clear debris - fallen branches and deadwood.   I created a pile 50 feet long and 10 feet high, which we chipped into mulch.

Then we created paths throughout the property which enabled us to manage the land.   We covered the paths with the mulch we created from chipping.

Once the rough clearing was done we had to move rocks.   New England is full of rocks.  Although I hand carried many and used a heavy duty wheelbarrow for others, we used a small front loader (Bobcat) for the really large ones.

Once the topography of the land was more obvious, we planned our planting areas, buildings and fences.  

A wetland engineer is working with the town of Sherborn to plan our future planting areas - likely an orchard of heirloom apples and a meadow filled with high bush blueberries.

We created a 10x12 chicken coop and a loafing shed to keep animals warm in winter/cool in summer.   We planned 1000 feet of fences and chose to use 5 foot woven wire fence supported by posts at 20 foot intervals, topped by a hot wire (9000 volts, low amperage) to keep the predators out.

The end result was 2 quarter acre paddocks - one for males and one for females, and a half acre pasture,  connected with a series of 8 gates that support manure management, hay storage, and easy movement of animals.

We then planned the barn.   The property included a barn, but it was originally designed as more of a garage than a barn.   We added hay loft doors,  thick rubber mats for the stalls, a water hydrant with a french drain, fans to keep animals cool in Summer, and wall mounted feeders.   We painted the building red with black trim and added barn lights above each door.

With this layout done, we had the infrastructure in place to complete our animal strategy.   We raised 12 chickens from 3 day old chicks indoors and moved them to the coop at 6 weeks.  A friend gave us a rooster.     We named him "Lucky" since he'll be living with vegans/vegetarians.

We raised 22 guinea fowl from 3 day old chicks and moved them to the coop at 6 weeks.

By pure happenstance,  my Telecom manager is selling her herd of 8 alpaca.   After meeting them, we purchased the entire herd - 3 males and 5 females.

Realizing that alpacas need guardians because they do not defend themselves well against the coyotes, fisher cats, and other predators on our property, we researched llamas.   We  found an ideal guard llama who has lived with alpaca for many years.   She also happens to be pregnant.

The female llama will guard the female alpaca.

For the male alpaca, we chose an experienced female Great Pyrenees mountain dog, the livestock guardian used by Basque shepherds.   We also chose a male Great Pyrenees puppy who will keep the female company and learn how to guard from her.

On August 18, the alpaca arrive.   On August 20, the female Great Pyrenees arrives.  On August 23, the male Great Pyrenees arrives.  On August 26 the llama arrives.

The journey of joyful chaos at Unity Farm has replaced the cancer journey and our property is about to blossom with new arrivals.