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Nationwide Health Information Network (NHIN) -- Implications for Disease RegistriesDan Russler M DDan Russler, M.D.VP Clinical InformaticsOracle Health Sciences Global Strategy

Agenda• Disease Registry Concepts

• What is a disease registry?• Types of disease registriesTypes of disease registries• Uses of disease registries• Populating a disease registry

• National Disease Registries• Why the US Nationwide Health Information Network (NHIN)?• Other National Examples• Other National Examples

• UK National Health Service “National Spine”• Canada Infoway “Provincial Reference Architecture”

• New Concepts in Disease Registries• Collaborative Disease Registries

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Disease Registry ConceptsWh t i “Di R i t ?”• What is a “Disease Registry?”

• A “Disease Registry” is a kind of “Patient Registry” • A list of patients with a focus on a specific disease• Includes patient characteristics related to the disease, e.g. lab resultsp , g

• Patient Registries include many other foci• Immunization Registries• Geographic Registries• Practice Registries• Practice Registries• ….

• What is a “Disease?”• DefinitionsDefinitions

• early 14c., "discomfort," from O.Fr. desaise, from des- "without, away" (see dis-) + aise "ease" (see ease). Sense of "sickness, illness" first recorded late 14c

• (Online Etymology Dictionary)

• a disordered or incorrectly functioning organ, part, structure, or system of the body• (based on Random House Dictionary)• (based on Random House Dictionary)

• Cause of Disease = Genetics + Environment + Timing• NIH Office of Rare Diseases Research

• “All diseases are rare diseases”

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Types of Disease Registries• “Common Disease” Registries

• Registries often planned at local, regional, national or international levels• May or may not use national communication architectures, especially atMay or may not use national communication architectures, especially at

local levels• Quality Disease Registry Examples

• a disease “practice register” is a UK NHS quality measurep g q y• a US provider “meaningful use” measure (“lists of patients by specific

conditions to use for…”)

• “Rare Disease” Registries• Adequate number of persons (denominator) may only be possible at

national and international levels• Since more organizations must participate in order to generate more

records, more likely to use national communication architectures for collaboration infrastructure

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Uses of Disease RegistriesL i M b t Q lit• Learning More about Quality• JCAHO requirements for quality improvement operations• CMS requirements for quality reporting

• Learning More about Disease• Dietary Patient Registries• Environmental Site Patient RegistriesEnvironmental Site Patient Registries• Genetic Tissue Bank Registries

• Learning More about Treatmentg• Clinical Trial Registries – medications and medical devices• Tumor Registries

• Tracking and Preventing Disease• Public Health Disease Registries• Bio-surveillance Registries

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Populating Disease Registries• Current Techniques are Manual

• “We have 200 full-time nurses abstracting data from paper and electronic medical records”

• “Nurses may spend 40 minutes per patient abstracting data for one disease registry”

A t t d T h i f Di R i t P l ti• Automated Techniques for Disease Registry Population• Require reliable, standardized data sources

• HL7 Continuity of Care Documents (CCD)• US Certified Electronic Health Records (EHRs)• US Certified Electronic Health Records (EHRs)

• Require standardized data targets for reporting• HL7 eMeasure Health Quality Measure Format (HQMF)• Other standardized reporting targets under developmentOther standardized reporting targets under development

• Reduce, but may not eliminate, manual chart abstraction time• About 30% of data still not normally standardized in EHRs

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Why the NHIN for Disease Registries?NHIN Value Propositions

• One legal network contract instead of multiple point-to-point legal contracts

O t h i l i ti

State HIE “awards will also strongly encourage states to consider participating

• One technical communication agreement instead of multiple point-to-

point technical agreements

• “The more organizations using the NHIN, th l bl th NHIN ill b f

p p gin the Nationwide Health Information Network as an approach to HIE. This

the more valuable the NHIN will become for everyone.” – a variation on Metcalfe’s Law

ppwould create a pathway toward seamless, nationwide health information exchange.” 12Feb2010 - Dr. David Blumenthal, The National Coordinator for Health InformationCoordinator for Health Information Technology

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US Disease Registry Opportunities?Sign the NHIN DURSA and Comply with Inspections

Add Disease Registries to NHIN(national or international registries)

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(national or international registries)

International Disease Registries• Very important for world-wide epidemic tracking

• More important for rare diseases than common diseases• Very rare diseases may only have a few people in each nation

V h d t t d di ith l f l i i t• Very hard to study diseases with only a few people in a registry

R i li ith ti l l d i t ti ith ti l• Requires compliance with national laws and integration with national architectures (via international standards)• National Architectures influence disease registry implementations

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National Health Architectures

Centralized EHR Architecture• User logs in to obtain central information• UK – direct login to Spine (see above)• Canada – login via EHR applications

Decentralized EHR Architecture• User logs into local EHR• EHR retrieves data only from other HIOs• US - No centralized data storage

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Canada login via EHR applications to centralized data (less direct than UK)

US No centralized data storage

UK Disease Registry Opportunities?Negotiation with the NHS “Ethics and Confidentiality Committee”

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Canadian Disease Registry Opportunities?Negotiation with the each Province for inclusion in the Provincial Architecture

Infoway ProvincialProvincial

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National Exchange InitiativesCompare Similarities• Based on HL7 V3 Reference

Information Model Standards

Contrast Differences• UK National Spine:

• Stores personal characteristics of patients, such as demographics • Stores summarised clinical information such as allergies, current medications and

• Interfaces with local HIT systems that connect to the national infrastructure

adverse reactions to drugs• Provides a Secondary Uses Service (SUS), using anonymised data for business

reports and statistics for research and planning• Interfaces with all the local IT systems within the National Programme.

• Canada Infoway Provincial Reference Architecture• Ensures the security of these

local systems that connect to the national infrastructure

y• Stores personal characteristics of patient, Client Registry• Stores clinical information, Shared Health Record Repository• Provides Public Health Surveillance Solution• Interfaces with local IT systems and privacy legislation are provincial rather than

national governance decisions• Provides access to a summary of the clinical record of each member

P id i f

national governance decisions• US Nationwide Health Information Network

• No central storage of personal characteristics; all person demographics are stored by Health Information Organizations (HIOs)

• No central storage of clinical information; all clinical information is stored by HIOs• Provides services for

population data reporting• Provides web services for Secondary Use, but secondary use reports are provided

only by HIOs, e.g. individual federal agencies or private reporting organizations• Interfaces with any public or private HIO that signs the NHIN contracts (DURSA) and

passes NHIN Gateway implementation testing inspections; interfaces with local public and private IT systems and privacy policies are local decisions driven by local

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regulation

Recent Concepts in Collaborative Disease RegistriesRequire an NHIN Exchange in placeq g p

• Multi-organizational collaborative disease registry governance• Many separately operated disease registries decide to collaborate• All agree to same privacy and security modelAll agree to same privacy and security model• Each disease registry collects data related to respective disease• Each registry allows a cross-walk between registries for individual patients

• Supports patients with multiple diseases (“co-morbidities)• Examples: patients with diabetes, hypertension, and obesity• Supports better clinical trial support

• Trials that require inclusion of multiple diseasesT i l th t i th t di l d d• Trials that require that some diseases are excluded

• Technical collaboration (data communication) between registries, e.g. data moving from PHR to local to national to international diseasedata moving from PHR to local to national to international disease registries• Requires strict data standardization!

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