The June HIT Standards Committee focused on an update and evaluation of the standards and interoperability framework initiatives, consistent with the overall theme of ONC’s recent reorganization and strategic plan to focus on fewer goals with a greater depth. Steve Posnack, who now leads the ONC Office of Standards and Technology, introduced the topic. Mera Choi and John Feikema provided an overall update. Evelyn Gallego, Jonathan Coleman, and Marc Hadley described their projects.
It was truly an amazing discussion. The energy in the room was palpable.
Common themes included
*Embrace FHIR, JSON, REST and OAuth
*Avoid a different standard for every use case - research, clinical care, and population health should use the same standards if the standards are suitable for purpose
*Limit scope as needed to get real transactions in production
*Use emerging technologies whenever possible - use "early automobiles" not faster horses or fancier buggy whips
*Keep it simple (as simple as possible but no simpler)
*Support modularity and an innovative ecosystem of third party apps with Application Programming Interfaces (read/write) in EHRs
*Data provenance (who generated the data) and data integrity/quality are important
*Integration of transactions into sender and receiver workflow must be considered
*Market forces are even more powerful incentives than certification/regulation
*A trust fabric with appropriate security to respect patient privacy preferences is foundational
With these themes in mind, every member of the committee was asked to name the most important standards and interoperability framework priority.
Everyone agreed that data provenance/integrity and support for query-based exchange via APIs were the topics we should work on.
The entire committee came to a conclusion, representing independent opinions from a multi-stakeholder perspective, that aligned perfectly with ONC’s 10 year vision. Per the recent ONC whitepaper, the goals of the next 3 years should be
*provider and patient ability to send, receive, query, and use data
*data provenance/quality and patient matching
*privacy and trust
At our next meeting we’ll drill deeper into a refinement of the standards and interoperability framework by asking what we are missing in the existing initiatives that is foundational to the ONC 10 year vision. Although Meaningful Use is important, we need to think about standards beyond the confines of the next stage of Meaningful Use.
After the framework discussion, Dixie Baker and Lisa Gallagher provided an update on the Privacy and Security Workgroup’s evaluation of the 2015 Certification Notice of Proposed Rulemaking. They recommended edits to 5 areas, which were approved by consensus:
Two-Factor Authentication - ONC should use a risk based framework aligned with DEA controlled substance e-prescribing without generally requiring two-factor authentication capability.
Accounting of Disclosures - given that the concept of a "Complete EHR" has been replaced with a series of selectable criteria, there no longer needs to be a statement that accounting of disclosures is optional.
Audit clarification within the context of ASTM E2147 - The PSWG believes it is feasible to certify EHR compliance with the ASTM E2147 audit log standard, and does not recommend ONC specify other actions in an updated standard for the 2017 Edition, or that ONC consider any additional standards.
Server authentication - A mechanism should exist for computer to computer data transfers as part of a trust fabric.
Automatic time-outs - A timeout should restrict access to protected health information and ONC does not need to be prescriptive about how this happens.
A great meeting!
Unity Farm Journal - Second Week of June 2014
My wife and I did not think it was possible for a duck to hatch guinea fowl, but this week it happened.
Guinea fowl are horrible parents.
They lay their eggs in piles throughout the forest and then abandon them. Even if a “designated layer” sits on the communal egg pile, the young often get wet and chilled after hatching and do not make it back to the coop.
A few weeks ago, the guineas decided to lay a few eggs in the duck house. Five of the ducks instantly began sitting on the eggs in shifts, keep them warm and protected.
Our sense was that dry guineas offer a very different humidity environment than constantly wet ducks.
Imagine Kathy’s surprise when she went into the duck house and found baby guineas running around.
In the end, it was nature over nurture - the guineas had no interest in swimming and the duck parents thought their new offspring were defective - a different kind of ugly duckling. We brought four baby guineas into the warmth of our brooder and today they are happy and healthy. In a few weeks, when they’re older and stronger, we’ll introduce the babies to the community of guineas so they can integrate into the family.
Speaking of ducks, one of our harlequins, Belle, had a traumatic eye injury, likely from her interactions with wild ducks which frequently visit the duck pond. As the farm medical care professional, I know that Pseudomonas infection of the eye is a real barnyard risk. Kathy and I did minor surgery to clean remove debris and loose tissue from the eye. We washed the eye with saline and have been using Tobramycin ophthalmic twice a day. They eye is now open and healing. Here's a comparison of the injured eye to the good eye. In a few weeks, we hope Belle will be good as new.
I’m 52 and too old for a mid-life crisis. Some older men seek a red car that brings back memories of their youth. Now that we are producing hundreds of pounds of vegetables, honey, mushrooms, and fiber, we needed something other than a Prius to haul farm goods to our customers. We purchased a 2013 Ford Transit, the last of the “european style” delivery vans available from Ford. Here’s my post mid-life crisis red car.
The weekend ahead will be a “honey do” list - spin honey, maintain hives, build new hives, create new honey frames, etc. I look forward to less trail building and more bee work.
Guinea fowl are horrible parents.
They lay their eggs in piles throughout the forest and then abandon them. Even if a “designated layer” sits on the communal egg pile, the young often get wet and chilled after hatching and do not make it back to the coop.
A few weeks ago, the guineas decided to lay a few eggs in the duck house. Five of the ducks instantly began sitting on the eggs in shifts, keep them warm and protected.
Our sense was that dry guineas offer a very different humidity environment than constantly wet ducks.
Imagine Kathy’s surprise when she went into the duck house and found baby guineas running around.
In the end, it was nature over nurture - the guineas had no interest in swimming and the duck parents thought their new offspring were defective - a different kind of ugly duckling. We brought four baby guineas into the warmth of our brooder and today they are happy and healthy. In a few weeks, when they’re older and stronger, we’ll introduce the babies to the community of guineas so they can integrate into the family.
Speaking of ducks, one of our harlequins, Belle, had a traumatic eye injury, likely from her interactions with wild ducks which frequently visit the duck pond. As the farm medical care professional, I know that Pseudomonas infection of the eye is a real barnyard risk. Kathy and I did minor surgery to clean remove debris and loose tissue from the eye. We washed the eye with saline and have been using Tobramycin ophthalmic twice a day. They eye is now open and healing. Here's a comparison of the injured eye to the good eye. In a few weeks, we hope Belle will be good as new.
I’m 52 and too old for a mid-life crisis. Some older men seek a red car that brings back memories of their youth. Now that we are producing hundreds of pounds of vegetables, honey, mushrooms, and fiber, we needed something other than a Prius to haul farm goods to our customers. We purchased a 2013 Ford Transit, the last of the “european style” delivery vans available from Ford. Here’s my post mid-life crisis red car.
The weekend ahead will be a “honey do” list - spin honey, maintain hives, build new hives, create new honey frames, etc. I look forward to less trail building and more bee work.
The ONC 10 Year Vision
On June 5th 2014, ONC released “Connecting Health and Care for the Nation: a 10-Year Vision to Achieve an Interoperable Health IT Infrastructure"
The plan is divided in 3 year goals, 6 year goals, and 10 year goals. Five specific tactics support the strategies.
Below is a summary of the report and a few comments from my Massachusetts experience that support the reasonableness of the ONC goals. Based on the trajectory of current technology and policy, I’m confident we can achieve these milestones. One caveat - since Meaningful Use Stage 3 takes effect in 2017, three years from now, we will need to adjust the scope and focus of Stage 3 to align with the ONC three year goals. I’ve written in previous posts that we should simplify future stages of Meaningful Use to less than 10 policy goals, highlighting interoperability, without being overly prescriptive. The ONC Vision gives us the opportunity to do that.
Three-Year Agenda: Send, Receive, Find, and Use Health Information to Improve Health Care Quality
1. Ensure that individuals and care providers can send, receive, find, and use a basic set of essential health information. This requires the ability to appropriately search for and retrieve health information, in addition to point-to-point information sharing.
Massachusetts has already built statewide Direct gateways for transport of payloads from one location to another. The Commonwealth is also live with a master citizen index, relationship locator service, consent repository, and the necessary web services/standards to support query/retrieve workflows. We stand ready to share 100% of our implementation guides with the HIT Standards Committee and ONC. I know that the send, receive, find, and use goal is achievable in three years, because Massachusetts is in production with the functionality today.
2. Address critical issues such as data provenance, data quality/reliability, and patient matching.
As with the first goal, the state government of Massachusetts has already implemented statewide patient data matching and a team to support demographic data cleanup. BIDMC has worked with the Massachusetts eHealth collaborative to build a community-wide Quality Data Center that successful merges CCDAs from the state HIE, taking into account data provenance, patient matching and data quality issues. We’ve experienced the operational realities of maintaining a public utility for patient identity management and data normalization, so we know it is possible to achieve at scale.
3. Enhance trust by addressing key privacy, security, and business policy and practice challenges to advance secure, authorized health information exchange across existing networks.
Massachusetts has established a set of HISP to HISP connections using a combination of whitelists and blacklists. Our approach has become simpler over time, shaped by the experience of day to day operations. I am confident that a trust fabric of federated networks is possible without overcomplicating the technology and policy.
Six-Year Agenda: Use Information to Improve Health Care Quality and Lower Cost
1. Enable individuals to be active participants in managing their care as an important contributor of information to the health record (e.g., patient experience, self-rated health, and self-generated data).
Since 1999, Beth Israel Deaconess has been gathering patient generated data in its PHR and EHR. Massachusetts has already connected sources of patient generated data to the health information exchange, delivering data from cloud-hosted consumer applications to the BIDMC EHR. I’ve reviewed the Apple Healthkit technology and am confident it can serve as healthcare device middleware in the home. I look forward to working with Apple on the terminology standards for HealthKit that will enable semantic interoperability between patients and providers.
2. Multi-payer claims databases, clinical data registries, and other data aggregators will incrementally become more integrated as part of an interoperable technology ecosystem.
As mentioned above, BIDMC has aggregated clinical and financial transactions for its ACO in a community wide quality data center connected to the health information exchange. We’ve sent over 2 million transactions from EHRs through the HIE to the data center and are confident that the all payer claims database, registries, and quality reporting goals in ONC’s Vision are achievable.
3. As value-based payment gains traction across Medicare, Medicaid, and commercial payers and purchasers, there will be new methods of measuring clinical quality that represent the most important aspects of care delivery and health outcomes.
Massachusetts stakeholders agree that current quality measurement methods are insufficient. BIDMC’s approach has been to send clinical observations, in the millions, to a third party cloud hosted solution which has the agility to compute all measures for ACO reporting, PQRS reporting, and pay for performance reporting. We do not need hardcoded quality measures in our EHRs and the cloud hosted approach provides low cost and high value. ONC’s vision is the right one.
10-Year Agenda: The Learning Health System
1. More standardized data collection, sharing, and aggregation for patient-centered outcomes research.
All the hospitals associated with Harvard have implemented I2B2 for federated query of clinical data in support of outcomes research. The ONC QueryHealth project in the Standards and Interoperability framework leverages the I2B2 experience. Hundreds of studies and thousands of queries have already been enabled by I2B2, so this is achievable.
2. Clinical decision support that is widely available to all stakeholders
BIDMC has implemented cloud hosted, centrally curated, decision support in several contexts including radiology ordering (with lab ordering currently in progress). As suggested by ONC HealtheDecisions project in the Standards and Interoperability framework, we send questions to the cloud and receive knowledge as a response. This works today and is definitely achievable in commercial EHR within 10 years.
3. Clinical trials, public health surveillance, and evidence available at the point of care
Massachusetts has connected all of its public health data gathering and reporting functionality to the state HIE. The Meaningful Use transactions (immunizations, syndromic surveillance, reportable lab) are already in live production. We are beginning work on query/retrieve of public health data (prescription drug monitoring program, immunization history), so I know this will be ready in 10 years.
The tactics listed by ONC include
1. Core technical standards and functions - although Meaningful Use includes most of the content, vocabulary and transport standards needed to support the ONC vision, there are a few gaps to fill. Massachusetts has already filled some of the gaps, so I’m confident the standards can be ready.
2. Certification to support adoption and optimization of health IT products and services - the concept of certification is good. Now that ONC has reorganized and those writing the regulation will be responsible for certification and testing, I’m confident that the certification challenges of the past can be overcome.
3. Privacy and security protections for health information - with increased Office of Civil Rights enforcement of the HIPAA Omnibus Rule, healthcare organizations throughout the country are building privacy educational programs and enhancing information security staffing, so the industry will be ready for new requirements.
4. Support business, clinical, cultural, and regulatory environment - To me, the one great challenge of Meaningful Use Stage 2 has been the readiness of the cultural environment for such requirements as community wide transition of care summary exchange. ONC’s focus on the ecosystem as well as policy/technology is welcome.
5. Rules of engagement and governance of health information exchange - Each state has implemented its own rules of the road. Massachusetts has solved its consent policy issues, but those solutions are different than other New England states. I do not expect ONC to establish a single set of policies for the country, but a framework for policy development and governance would be very helpful.
ONC has done a good job with this vision statement, outlining a series of stepwise goals, reducing the scope of its projects so that existing staff/budgets can be applied at greater depth to fewer initiatives. I look forward to being a part of the process.
The plan is divided in 3 year goals, 6 year goals, and 10 year goals. Five specific tactics support the strategies.
Below is a summary of the report and a few comments from my Massachusetts experience that support the reasonableness of the ONC goals. Based on the trajectory of current technology and policy, I’m confident we can achieve these milestones. One caveat - since Meaningful Use Stage 3 takes effect in 2017, three years from now, we will need to adjust the scope and focus of Stage 3 to align with the ONC three year goals. I’ve written in previous posts that we should simplify future stages of Meaningful Use to less than 10 policy goals, highlighting interoperability, without being overly prescriptive. The ONC Vision gives us the opportunity to do that.
Three-Year Agenda: Send, Receive, Find, and Use Health Information to Improve Health Care Quality
1. Ensure that individuals and care providers can send, receive, find, and use a basic set of essential health information. This requires the ability to appropriately search for and retrieve health information, in addition to point-to-point information sharing.
Massachusetts has already built statewide Direct gateways for transport of payloads from one location to another. The Commonwealth is also live with a master citizen index, relationship locator service, consent repository, and the necessary web services/standards to support query/retrieve workflows. We stand ready to share 100% of our implementation guides with the HIT Standards Committee and ONC. I know that the send, receive, find, and use goal is achievable in three years, because Massachusetts is in production with the functionality today.
2. Address critical issues such as data provenance, data quality/reliability, and patient matching.
As with the first goal, the state government of Massachusetts has already implemented statewide patient data matching and a team to support demographic data cleanup. BIDMC has worked with the Massachusetts eHealth collaborative to build a community-wide Quality Data Center that successful merges CCDAs from the state HIE, taking into account data provenance, patient matching and data quality issues. We’ve experienced the operational realities of maintaining a public utility for patient identity management and data normalization, so we know it is possible to achieve at scale.
3. Enhance trust by addressing key privacy, security, and business policy and practice challenges to advance secure, authorized health information exchange across existing networks.
Massachusetts has established a set of HISP to HISP connections using a combination of whitelists and blacklists. Our approach has become simpler over time, shaped by the experience of day to day operations. I am confident that a trust fabric of federated networks is possible without overcomplicating the technology and policy.
Six-Year Agenda: Use Information to Improve Health Care Quality and Lower Cost
1. Enable individuals to be active participants in managing their care as an important contributor of information to the health record (e.g., patient experience, self-rated health, and self-generated data).
Since 1999, Beth Israel Deaconess has been gathering patient generated data in its PHR and EHR. Massachusetts has already connected sources of patient generated data to the health information exchange, delivering data from cloud-hosted consumer applications to the BIDMC EHR. I’ve reviewed the Apple Healthkit technology and am confident it can serve as healthcare device middleware in the home. I look forward to working with Apple on the terminology standards for HealthKit that will enable semantic interoperability between patients and providers.
2. Multi-payer claims databases, clinical data registries, and other data aggregators will incrementally become more integrated as part of an interoperable technology ecosystem.
As mentioned above, BIDMC has aggregated clinical and financial transactions for its ACO in a community wide quality data center connected to the health information exchange. We’ve sent over 2 million transactions from EHRs through the HIE to the data center and are confident that the all payer claims database, registries, and quality reporting goals in ONC’s Vision are achievable.
3. As value-based payment gains traction across Medicare, Medicaid, and commercial payers and purchasers, there will be new methods of measuring clinical quality that represent the most important aspects of care delivery and health outcomes.
Massachusetts stakeholders agree that current quality measurement methods are insufficient. BIDMC’s approach has been to send clinical observations, in the millions, to a third party cloud hosted solution which has the agility to compute all measures for ACO reporting, PQRS reporting, and pay for performance reporting. We do not need hardcoded quality measures in our EHRs and the cloud hosted approach provides low cost and high value. ONC’s vision is the right one.
10-Year Agenda: The Learning Health System
1. More standardized data collection, sharing, and aggregation for patient-centered outcomes research.
All the hospitals associated with Harvard have implemented I2B2 for federated query of clinical data in support of outcomes research. The ONC QueryHealth project in the Standards and Interoperability framework leverages the I2B2 experience. Hundreds of studies and thousands of queries have already been enabled by I2B2, so this is achievable.
2. Clinical decision support that is widely available to all stakeholders
BIDMC has implemented cloud hosted, centrally curated, decision support in several contexts including radiology ordering (with lab ordering currently in progress). As suggested by ONC HealtheDecisions project in the Standards and Interoperability framework, we send questions to the cloud and receive knowledge as a response. This works today and is definitely achievable in commercial EHR within 10 years.
3. Clinical trials, public health surveillance, and evidence available at the point of care
Massachusetts has connected all of its public health data gathering and reporting functionality to the state HIE. The Meaningful Use transactions (immunizations, syndromic surveillance, reportable lab) are already in live production. We are beginning work on query/retrieve of public health data (prescription drug monitoring program, immunization history), so I know this will be ready in 10 years.
The tactics listed by ONC include
1. Core technical standards and functions - although Meaningful Use includes most of the content, vocabulary and transport standards needed to support the ONC vision, there are a few gaps to fill. Massachusetts has already filled some of the gaps, so I’m confident the standards can be ready.
2. Certification to support adoption and optimization of health IT products and services - the concept of certification is good. Now that ONC has reorganized and those writing the regulation will be responsible for certification and testing, I’m confident that the certification challenges of the past can be overcome.
3. Privacy and security protections for health information - with increased Office of Civil Rights enforcement of the HIPAA Omnibus Rule, healthcare organizations throughout the country are building privacy educational programs and enhancing information security staffing, so the industry will be ready for new requirements.
4. Support business, clinical, cultural, and regulatory environment - To me, the one great challenge of Meaningful Use Stage 2 has been the readiness of the cultural environment for such requirements as community wide transition of care summary exchange. ONC’s focus on the ecosystem as well as policy/technology is welcome.
5. Rules of engagement and governance of health information exchange - Each state has implemented its own rules of the road. Massachusetts has solved its consent policy issues, but those solutions are different than other New England states. I do not expect ONC to establish a single set of policies for the country, but a framework for policy development and governance would be very helpful.
ONC has done a good job with this vision statement, outlining a series of stepwise goals, reducing the scope of its projects so that existing staff/budgets can be applied at greater depth to fewer initiatives. I look forward to being a part of the process.
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