Friday, August 31, 2012

Massachusetts Datapalooza

Massachusetts is creating an ecosystem which enables providers, patients, and payers to exchange health information with patient consent at low cost using Meaningful Use Stage 2 standards.   It goes live October 15.

We're also encouraging innovative companies to create applications that will empower healthcare stakeholders using this newly freed data.    Our upcoming Healthmart Conference and Datapalooza will showcase these efforts.

The HealthMart Conference, Trade Show, and Datapalooza will be held on October 2-3 at the DCU Center in Worcester.  Day one will address the topics of EHR deployment, accountable care, mobile health, and analytics.  Day two will be the Datapalooza, which is a competition among innovators to develop apps and products using federal health data, and I will be one of the judges.  Attendee, Datapalooza contestant, and vendor registration are now open at the Massachusetts Health Data Consortium's website.  Contestant registration is now free!

Thursday, August 30, 2012

The Citizens of Unity Farm

I'm on vacation this week, introducing new livestock to our farm.     We now have our full complement of animals:

2 Great Pyrenees mountain dogs
8 alpacas
1 llama
13 chickens
22 guinea fowl
2 rabbits
2 cats

Here's a brief introduction to the citizens who have recently moved in.

Our two Great Pyrenees mountain dogs are livestock guardians for the male alpacas.  Bundle is a 9 month old female from Rosasharn farm in Rehoboth, MA
Shiro is a 9 week old male from a breeder in New Gloucester, Maine who also has dogs with Rosasharn bloodlines.  Shiro's grandmother is also Bundle's grandmother.   Bundle's father is Shiro's grandfather.    Although Bundle and Shiro have know each other less than a week, they're already best friends.   Bundle is teaching Shiro how to guard effectively.   They have boundless energy.

Our 8 alpacas are from Bittersweet Cove Farm in Maine.  At Unity, they are separated into two paddocks - 3 males and 5 females.    Our males are Stanley (1 year old), Midas (3 years old) and Domino (3 years old).   They're very good natured and Stanley likes to rub noses with his humans.   Our females are Ella Mae (5 years old), Tinkerbell (4 years old), Persia (2 years old), Daisy Mae (1 year old), and Mocha (7 years old).    They have very fine fiber and spend their days enjoying hay and fresh growing orchard grass in the warmth of summer.


Our llama is Black Orchid from Fort Lucas farm in Colrain, MA.  She guards the female alpaca vigilantly.   She's pregnant and today she'll have her first pre-natal visit from a traveling vet.

We have 12 hens and 1 rooster.   Each is named according to their color and personality - we have i.e. Rainbow, Terra, Clover, Silver, Chipmunk, Midnight.  Our rooster is named Lucky since we received him as a gift from a farm that prepares roosters for Sunday dinner.   Our hens will begin laying very soon.


Our 22 guinea fowl roost in the coop at night but spend their days wandering our property, eating ticks and other high protein foods they find in the forest.   They ground flock - moving together a single large group.   We have 9 blacks, 11 silvers, and 2 whites.  One of the guineas is not able to walk due to a birth defect, but he's a fighter and has learned how to hop along with the flock.   Every night one of the large guineas flies down from the rafters of the coop to keep him company.

Our rabbits are 10 years old and share the coop with the chickens.  The male is Jack and the female is Annie.  They enjoy the scraps of fresh vegetables we bring to the flock - broccoli stems from the garden, corn cobs, and lettuce.

Our cats are also 10 years old.  Tigger enjoys sleeping in the sun, while his sister, Lily spends her time exploring the house and looking for small creatures to chase.

Since moving to the farm at the end of April, we've had to build the infrastructure and support systems to keep our barnyard citizens healthy and happy.  Picking the right hay, controlling flies, and managing manure are all skills we did not have a few months ago.   In upcoming Thursday posts, I'll share all our lessons learned on topics that may be unfamiliar territory for my usual readers!

Tuesday, August 28, 2012

Learning More About the New MU Rules

On Thursday, August 30, 2012, from 12p-2p, the National eHealth Collaborative, will host an important webinar led by CMS and ONC experts.  I've reviewed the slides and this will be an excellent presentation. To sign up, visit the program website.


Program Description:

The final rules for Meaningful Use Stage 2 and the Standards and Certification Criteria were released on August 23. On August 30, NeHC will host experts on both of these rules to describe the intricacies and answer questions on each rule. NeHC will be joined by Travis Broome from CMS’s Office of E-Health Standards and Services to give an overview of the final rule and answer questions. Travis will also discuss the feedback that was incorporated into the final rule and what this means for those ready to attest for both Stage 1 and Stage 2. Then, NeHC will welcome Steve Posnack, Director of the Federal Policy Division at the Office of the National Coordinator for Health IT (ONC) for an in-depth look at the 2014 Edition Standards and Certification Criteria final rule. Steve will discuss the revised definition for Certified EHR Technology, identify changes from the proposed rule, and give his insight into the next steps.

Faculty:

Travis Broome – Health Insurance Specialist, Office of E-Health Standards and Services, CMS
Steve Posnack – Director, Federal Policy Division, ONC

Monday, August 27, 2012

The Meaningful Use Stage 2 Balance


Over the past 4 days many people have written about Meaningful Use Stage 2.  Some have said it too aggressive, some have said it is not aggressive enough.

To me, the perfect compromise means that every stakeholder is just a little unhappy but all can live with the outcome.

I believe MU Stage 2 achieves this level of balance.

Complaints I've heard include

*The NPRM required that 10% of transitions of care include electronic transmission of structured data across vendor boundaries. The final rule still requires 10% transmissions but eliminates the requirement for transmission across vendor boundaries, instead noting that a single transition of care must be sent across vendor boundaries or to a test EHR operated by CMS for the purpose of receiving and validating these transactions.   Some have said that proprietary HIE within a single vendor product may still persist.   My experience in Massachusetts suggests that the care coordination demands of accountable care organizations are creating pressures on vendors to open their platforms to third party analytics, personal health records, and community HIE infrastructures.   The Meaningful Use requirement to reconcile problems, meds, and allergies plus the required demonstration of data exchange across vendor boundaries will melt away proprietary silos of data.

*The NPRM required that EHRs support "download and transmit" of DICOM images to third-parties:

"We propose to require EHR technology to be capable of enabling images formatted according to the Digital Imaging and Communications in Medicine (DICOM) standard to be downloaded and transmitted to a third party. We believe this specific capability has the potential to empower patients to play a greater role in their own care coordination and could help assist in reducing the amount of redundant and duplicative imaging-oriented tests performed. In fact, the National Institutes of Health has recently funded activities focused on personally controlled sharing of medical images and published a solicitation notice on the same topic."

The final rule drops this requirement and includes only viewing of image data within the EHR.

"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."

Although many people will argue with me, I believe that cross organizational internet-based DICOM exchange still needs refinement before making it a certification requirement.  If the standards for ubiquitous exchange across EHRs are good enough, then why do third party cloud-based image exchange companies such as LifeImage have so many customers?

I agree that image exchange is important to reduce costs and enhance quality of care.   It's a perfect requirement for Stage 3, once EHRs have enabled view capability and the Standards Committee has reviewed existing standards to assess the readiness of existing implementation guides for cross organizational internet-based exchange.

*There have been questions about the protection of patient privacy, given the increased amount of data sharing in MU Stage 2

I think of privacy as maintaining confidentiality per personal preferences.

Per wikipedia's definition of informational privacy

"Medical privacy allows a person to withhold their medical records and other information from others, perhaps because of fears that it might affect their insurance coverage or employment, or to avoid the embarrassment caused by revealing medical conditions or treatments."

Patient accessible audit trails enable the patient to monitor/enforce their preferences for information sharing

Encryption prevents breaches when mobile devices are stolen.  Encryption of client devices is required by MU Stage 2

"7) End-user device encryption. Paragraph (d)(7)(i) or (ii) of this section must be met to satisfy this certification criterion.

(i) EHR technology that is designed to locally store electronic health information on end-user devices must encrypt the electronic health information stored on such devices after use of EHR technology on those devices stops."

In addition, given that audit trails record the encryption status of client devices, the Office of Civil Rights can hold individuals accountable for breaches involving non-encrypted client devices.  Increased enforcement will lead to increased encryption.

*Some complained about the real world operational impact of the workflow changes implied by MU Stage 2.

The Standards Committee is compromised of world class professionals who implement systems for a living.   Their advice (especially that of the Implementation Workgroup) is from the trenches.

My honest opinion is that MU Stage 2 creates stretch goals for vendors, IT departments, and providers, but all are achievable.   MU Stage 2 lives up the metric first articulated by David Blumenthal - the escalator should move up fast, but not so fast that people fall off.

Next week I'll met with the BIDMC CEO to finalized my major thematic goals for FY13.  I'll tell him that MU Stage 2, ICD10 and Compliance/Regulatory support are my focus for the next year.    The change management of implementing so many new applications and workflows will not be easy, but the taking the uphill road often leads to the best views.   I believe the MU Stage 2 appropriately balances policy goals, change management realities and clinical quality imperatives.

Friday, August 24, 2012

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.

Thursday, August 23, 2012

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.

Monday, August 20, 2012

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.