On Wednesday, July 29, HIMSS India Chapter provided written comments to National Health Authority (NHA) in response to the proposed National Digital Health Mission (NDHM) implementation based on National Digital Health Blueprint (NDHB) and subsequent NDHM stakeholder discussions held by NHA.
Recommendations to the National Health Authority (NHA) specifically touched upon the areas that includes the scope of EHR/PHR, Unique Health Identifier, Registries – Patient/Person/Doctor/Provider, Consent Management, Health Information Exchange (HIE), adoption of healthcare standards, need for transparent RFP process and regulatory framework.
Public Policy Committee – HIMSS India Chapter
Bangalore 29th July 2020
Dr. Indu Bhushan
Chief Executive Officer
National Health Authority (NHA) Government of India
New Delhi – 110001
Dear Dr. Bhushan:
On behalf of the Healthcare Information and Management Systems Society (HIMSS) India chapter, we are pleased to provide the written public comments based on National Digital Health Mission (NDHM) stakeholder discussion held on 8th July 2020.
We appreciate this opportunity to utilize our members’ expertise in offering the feedback in building National Digital Health Mission that aims to develop the key building blocks supporting the unified digital health infrastructure in the country that will provide seamless and secure access, exchange, and use of electronic health information (EHI).
HIMSS is a global advisor and thought leader supporting the transformation of health through information and technology. As a mission-driven charitable organization, HIMSS offers a unique perspective with deep expertise in health innovation, interoperability, public policy, workforce development, research, and analytics to advise global leaders, stakeholders, and influencers on best practices in health information and technology.
Through our innovation companies, HIMSS delivers key insights, education, and engaging events to healthcare providers, governments, and market suppliers, ensuring that they have the right information at the point of decision.
As an association, HIMSS encompasses more than 76,000 individual members and 660 corporate members globally. We collaborate with hundreds of providers, academic institutions, and health services organizations on strategic initiatives to advance the use of innovative information and technology. Together, we work to improve health, access, as well as the quality and cost-effectiveness of healthcare.
National Digital Health Mission (NDHM) addresses many of the issues that are critical to set up the National Electronic Health Record for every citizen. HIMSS India Chapter commends Ministry of Health & Family Welfare, Niti Aayog and National Health Authority for its work to implement National Electronic Health Record and put the health system and stakeholders on a path to transform healthcare.
HIMSS India Chapter has been championing the need for National EHR since 2015 and we appreciate the efforts of the Government of India to provide the citizens with secure access to actionable information that assists them in directing their own healthcare.
The implementation of National EHR is a complex task and it requires serious well thought out planning backed with strong global healthcare informatics expertise. A badly designed national EHR system will not only be a pain for clinicians for but also could endanger patients as we have seen in other countries where the cost of redesign is significant. HIMSS India Chapter strongly feels that there are significant gaps and opportunities for improvement in the current approach laid out by National Health Authority (NHA) and it requires serious reconsideration.
In this regard HIMSS India Chapter would like to provide recommendations to ensure a well-defined plan to address the gaps based on the National Digital Health Blue Print final version of the document and NDHM stakeholder discussion held on 8th July.
HIMSS India chapter public comments are as below:
Overview of key HIMSS India public comments
The basics of PHR Vs EHR
As Minster of State Health & Family Welfare Hon’ble Shri. Ashwini Kumar Choubey has mentioned that the implementation of NDHB would ensure the interoperability of data, creation of standardized “EHR” and providing continuum of care. The NDHM Architecture shared in the stakeholder discussion has mentioned building only a “PHR”. However to achieve the key objectives of NDHM we need to ensure that we have both EHR as well as PHR as part of the minimum viable architecture.
Just to reiterate the definition of EMR Vs EHR Vs PHR:
Electronic Medical Record (EMR)
An electronic record of health-related information on an individual that can be created, gathered, managed, and consulted by authorized clinicians and staff within one health care organization.
Electronic Health Record (EHR)
An electronic record of health-related information on an individual that conforms to nationally recognized interoperability standards and that can be created, managed, and consulted by authorized clinicians and staff across more than one health care organization.
Personal Health Record (PHR)
An electronic record of health-related information on an individual that conforms to nationally recognized interoperability standards and that can be drawn from multiple sources while being managed, shared, and controlled by the individual.
Unique identification of persons, facilities, diseases and devices is a key requirement as well as a challenge in the National Digital Health Ecosystem (NDHE). The Blueprint handles this requirement through 2 building blocks, viz. Unique Health Identifier (UHID) and the Health Locker.
The minimum viable architecture of NDHM doesn’t have any mention of Master Person Index (MPI). The ability to automate the process of matching records and maintaining cross reference index of identifiers for individuals and organizations is seen as a key enabler for efficient and accurate Unique Health Identifier (UHID). The UHID matching logic should support both deterministic and probabilistic matching algorithms, using multiple attributes with agreement and disagreement weight. The UHID matching logic should support techniques like person name and address standardization and phonetic encoder to increase the accuracy and effectiveness.
HIMSS has long been involved in leading private sector efforts to improve patient matching. HIMSS strongly supports the use of matching algorithms as part of an overall patient matching strategy, which should include work to create a benchmark measurement for algorithms that have already been developed and to be developed in future.
HIMSS India Chapter strongly recommends to allocate an independent identifier as the UHID. The independent identifier can be linked to identifiers from other national person identifier systems. This approach will enable the flexibility of UHID data stewardship. For a patient or an organization registry in particular, the ability to support standards-based APIs that allow it to be seamlessly integrated and to support Personal Health Record, is seen as a key enabler of health information exchange. HIMSS India Chapter strongly recommends to leverage the Integrating the Health Enterprise (IHE) based profiles for the patient, provider and facility registry. Globally National EHR systems have adopted the IHE. IHE produces Profiles using FHIR R4 for core functionality.
Some of the solutions that address the requirements of Patient Registry include additional functionality that enables implicit and explicit creation of Family Taxonomies, Provider Organization Member/Employee Taxonomies, Care Team taxonomies, etc., as a side effect of registering patients, family members, beneficiaries, doctors, providers, etc. It is suggested that considering a solution that includes this functionality would be advantageous.
The Electronic Health Record (EHR) has two key dimensions i.e. the physician view and patient view. The Health Locker addresses the ability to store PHR but how the doctors will be able to access patient’s family history, allergies, vital signs etc. need to be mentioned in detail. In addition to the Health Locker there is a need to have unified portal for clinicians and citizens to access their health records.
Patient/Person/Doctor/Provider Registries are in production used as part of EHRs at national and regional level, and independently in hospital and hospital group contexts in many countries in the world including Australia, Canada, Norway, UK, United States and elsewhere. Support for standards-compliance, vendor product compliance, availability of practical industry experience and international health systems experience could be drawn upon from the lessons learnt and best practices.
Health Facilities Registry
HIMSS India recommends National Digital Health Mission (NDHM) to evaluate standards based registries compliant with IHE and FHIR R4. In particular, IHE Profile – Healthcare Provider Directory (HPD) can be looked at to harmonize healthcare provider and facility registries. The Healthcare Provider Directory (HPD) profile supports management of healthcare provider information in a directory structure.
- HPD directory structure is a listing of the following two categories of healthcare providers that are classified by provider type, specialties, credentials, demographics and service locations: Individual Provider
- A person who provides healthcare services, such as a physician, nurse, or pharmacist.
- Organizational Providers – Organizations that provide or support healthcare services, such as hospitals, Counseling Organizations, Healthcare Information Exchanges (HIEs), Nursing Homes, Diagnostic Laboratories etc.
Typical provider information maintained by the directory is demographics, address, credential and specialty information as well as electronic endpoint to facilitate trusted communications with a provider. The directory can also maintain relationship.
Approach on Single Central Registry Vs Multiple Registries
National Health Registries are expected to be the single source of truth for master data pertaining to various health-sector stakeholders.
This process would, over time, build and maintain a cross-reference index of all identifiers associated with each entity (e.g. Aadhaar, Jan Dhan, driver’s license number, etc.), a history of all source records associated with the unique identifier and a history of all changes to the entity master record and its corresponding source records.
A single central person registry may not be optimal for the population of India. It may be advantageous to consider a 2-/3-level hierarchy of person registries, with central registry consolidating registrations from existing registries such as ROHINI, state-based registries and perhaps these consolidating registrations from smaller administrative divisions or groups of healthcare organizations.
This model would permit the lookup of person details across the geographic and administrative boundaries while localizing the search and improving the retrieval efficiency, and distributing the maintenance burden amongst operators of registries. HIMSS India Chapter suggests on the basis that most patients will receive services in their local areas and seek services elsewhere only on relatively few occasions.
It is important that NDHM leverages well defined consent management frame work. There are several consent models used by HIEs and the consent management framework should be flexible to adopt varying needs of the citizens.
- No consent– Patient health information at a participating healthcare organization is automatically included in and available through the HIE (NOTE: This is not recommended, and is rarely used.)
- Opt-out – All or some pre-defined data sets are qualified to be included and available for exchange, after patients are given the opportunity to opt out in full.
- Opt-out with exceptions – All or some pre-defined data sets are qualified to be included and available for exchange after patients are given the opportunity to:
- opt out in full;
- selectively exclude categories of data or specific data elements from the exchange;
- limit exchange of their information to specific providers or provider organizations; and/or
- limit exchange of their information only for specific purposes.
- Opt-in – No patient data sets are made available for electronic exchange until patients actively express whether they would like to make all, or a pre-defined set, of their information available.
- Opt-in with restrictions – No patient data sets are made available for electronic exchange until patients actively give their consent to participate. Patients have the option to:
- make all of their information available for exchange;
- include only specific categories of data or data elements;
- allow information to flow only to specific providers; and/or
- allow the exchange of their information only for specific purposes.
The stakeholder discussion has a specific mention about opt-in model for voluntary citizen participation in the NDHM. There are several countries globally tried opt-in model and their adoption is very limited and very recently Australia has moved to Opt Out model and since then their adoption rate has increased significantly.
HIMSS India recommends NDHM to explore Opt Out based model which will increase the adoption of EHR. The Consent Management framework envisaged by NDHM should have adequate flexibility to change Opt-In to Opt Out or with/ without restrictions as the need arises in future. At this point NHA is trying to retrofit the consent framework developed for the financial services industry in NDHM and it may not be a best approach given the complexities involved in healthcare consent model.
Data Exchange Vs Health Information Exchange (HIE)
The minimum viable architecture of NDHM shared in the stakeholder discussion has a specific mention of “data exchange”. There is a significant difference between “Data Exchange” and “Health Information Exchange”.
The Health Information Exchange (HIE) is the cornerstone of any national EHR implementation. The National Digital Health Blue Print (NDHB) has specially called out “HIE” as a critical capability to be a part of the key building blocks. In similar lines Health Domain Metadata and Data Standards document released by Ministry of Health & Family Welfare has clearly called out the need for “Health Information Exchange”.
The data exchange is one of many capabilities in Health Information Exchange (HIE). Health information exchange offers many benefits that EHRs, in general, do not, such as:
- Care coordination – This is a dynamic process that requires data movement across platforms and among service providers in real time. Many EHR systems, in spite of being developed by the same company, do not talk to each other, creating delays and decreasing the value of the system.
- Record Locator Services / Master Patient Indexes– Enable creation of one continuous community record, facilitating patient identification across multiple provider settings.
- Data exchange – HIE provides support for vocabulary and code sets including content mapping, terminology normalization and enable data transactions to occur automatically across multiple providers and settings.
- Data aggregation and analysis – This includes clinical data aggregation across health information exchange partners, as well as data analytics and warehousing.
- Clinical messaging – Standard HIE services often include laboratory results, emergency room notes, medication lists, discharge summaries, progress notes, radiology results and surgical notes.
- Secure messaging between providers – HIEs can be used for generalized communication between physicians in different healthcare entities and/or using different EHRs. For instance, providers needing to send transition of care documents for consultations or referrals can use HIE services to eliminate sending paper documents, and to expedite the patient’s treatment.
- HIE Workflows
- Patient intake – Using an HIE’s query and response process, the patient’s summary clinical record can be pre-fetched and available immediately when the provider wants to look at it.
- Patient exam- A physician can utilize an HIE to access the appropriate patient data from other sources, such as other providers and hospitals. The physician can then select certain patient documents (such as medication lists and reconciliations, allergy lists or lab reports) that they want to have filed in their local EHR for access during a patient visit.
- Query services – Physicians may want to obtain more information about a patient that is referred to their office. They can query their local HIE and, using the record locator services profile, the local HIE can query other HIE service providers to assemble a full Patient Health Record (PHR).
- Transitions of Care (TOC) – As patients make the transition from one care setting to another (such as from hospital to clinic), HIE services allow the documentation from one care setting to be easily accessed from the next.
- Referrals – Organizations have the ability to send referrals directly through the HIE/HIO, along with all the appropriate documentation.
- Lab results – HIE services provide physicians with the ability to get results directly through the HIE.
Adoption of Standards in NDHM
Compliance to agreed Industry standards makes any system more universal, adaptable and interoperable. The National Digital Health Blueprint clearly mandates the use of EHR Standards recommended by MoHFW and FHIR Standards by HL7.
In addition Ministry of Health & Family Welfare has invested significant effort to promote SNOMED-CT in India. Bureau of India Standards (BIS) & National Resource Center for EHR standards have played a key role in defining healthcare standards in India.
It is important that the NHA leverages the standards as mandated in the National Digital Health Blueprint (NDHB). We therefore urge the NDHM to uphold this commitment.
Terminologies and code sets standardized by the industry bodies or Standards organizations, may change over time, may be versioned and perhaps may be cross- mapped to other terminologies where terminology domains overlap to a significant degree, making it possible for the user to use one or another terminology for coded data for the same subject entities. Terminology normalization would typically be required when semantic interoperability of clinical information is desired. The Personal Health Record (PHR) would require terminology normalisation if, for example, different laboratories use different medical terminologies to code the same laboratory tests.
Terminology Normalization can be externalized as an Enterprise Terminology Service, which would both serve as a terminology/code registry for the various standard and local terminologies and as a service that provides transformation between semantically equivalent codes in different terminologies or different versions of the same terminology.
It seems advantageous to implement the terminology registry as not just the registry for code lookups but also as a terminology transformation service.
The Health Information Exchange (HIE) should have the ability to handle terminology normalization. Clinical and Business Data Dictionaries may be standardized by standards bodies, industry bodies and the government entities. The structure may vary but is likely to include the code and its definition, perhaps temporal validity and similar system attributes that would aid in search and determination of the applicability and validity.
Transparency & Competitive RFP Process for NDHM Implementation
HIMSS India Chapter strongly feels that there should be an open, transparent and competitive RFP process to implement all the key building blocks of NDHM. Indian Software Products Industry Round Table (iSPIRT) has developed National Health Stack and they had conducted series of webinars to promote their health stack.
HIMSS India Chapter asks NHA to clarify the reasons for allowing iSPIRT to develop these solutions while there was a formal RFP for PMJAY 2.0 in place. We believe that iSPIRT being an advisor and moderator should have facilitated the process instead of building their own health stack.
Based on the architectural and skillset requirements as highlighted above in the document, a transparent discussion on Build Vs Buy should happen giving chance to Healthcare IT vendors to compete and present the best solution. HIMSS India Chapter asks NHA to consider an open and transparent RFP process and select vendors with proven expertise to implement key building blocks of NDHM.
The draft data protection bill was submitted to the Electronics and IT Minister Hon’ble Shri. Ravi Shankar Prasad by the BN Srikrishna Committee on 27 July 2018. The proposed legislation is being reviewed by the Joint Parliamentary Committee. An initiative on personal health records should ideally succeed this bill, so that the health records are compliant with all the regulatory requirements.
HIMSS India Chapter would like to thank National Health Authority (NHA) for the opportunity to comment on the National Digital Health Mission (NDHM) as we strongly support its focus on advancing interoperability, supporting the access, exchange, and the use of Electronic Health Information (EHI).
In conclusion, HIMSS India Chapter will continue to emphasize the need for the well-defined architecture, adoption of healthcare standards and strategic roadmap in implementing a successful national EHR and a transparent RFP process to enable National Digital Health Mission (NDHM) building blocks across the entire stakeholder community.
We look forward to an opportunity to discuss these issues in more depth. Please feel free to contact us at firstname.lastname@example.org , with questions or for more information.
Thank you for your consideration.
HIMSS India Chapter
Hon’ble Prime Minister’s Office Government of India
Hon’ble Dr. Harsh Vardhan, Union Minister
Ministry of Health and Family Welfare, Government of India
Hon’ble Shri. Ashwini Kumar Choubey, Minister of State Ministry of Health and Family Welfare, Government of India
Smt. Dr. Preeti Sudan IAS, Secretary
Ministry of Health and Family Welfare, Government of India