EHR Standards for India: A beginning of Integrated Indian Healthcare System

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Difference between EMR and EHR

Electronic Medical Record or EMR is the digital version of paper based Medical Record of a patient. EMR has been defined by the Healthcare Information and Management Systems Society(HIMSS) as ‘An application environment composed of the clinical data repository, clinical decision support, controlled medical vocabulary, order entry, computerized provider order entry, pharmacy, and clinical documentation applications. This environment supports the patient’s electronic medical record across inpatient and outpatient environments, andis used by healthcare practitioners to document, monitor, and manage health care delivery within a Care Delivery Organization (CDO). The data in the EMR is the legal record of what happened to the patient during their encounter at the CDO and is owned by the CDO’.9. The terms EMR and EHR are used interchangeably. ISO 18308:2011 defines the ‘set of requirements that shall be met by the architecture of systems and services, processing, managing, and communicating electronic health record (EHR) information. This is in order to ensure that these EHRs are faithful to the needs of healthcare delivery, are clinically valid and reliable, are ethically sound, meet prevailing legal requirements; support good clinical practice and facilitate data analysis for a multitude of purposes’. For the purposes of this,the EHR is defined by the ISO as ‘one or more repositories, physically or virtually integrated, of information in computer processable form, relevant to the wellness, health and healthcare of an individual, capable of being stored and communicated securely and of being accessible by multiple authorized users, represented according to a standardized or commonly agreed logical information model. Its primary purpose is the support of life-long, effective, high quality and safe integrated healthcare.’11An EHR is a‘longitudinal electronic record of patient health information generated by one or more encounters in any care delivery setting’ 12 and is a developmental health record from inception or birth through life, arranged in a chronological fashion, of every clinical encounter, with a summary and detailed view of various clinical events or encounters in the lifetime of a person.

Need for Integrated Healthcare in India

From the perspective of Indian Healthcare system, patients visit several health providers, throughout their life span, right from visiting a sub-center, community-center or primary-health centre in rural setups, or a general practitioner in his local vicinity, to a government /private hospital or clinic at the district, city, state or central level. Health records get generated with every clinical encounter during these ambulatory, inpatient or emergency visits. However, most health records are either lost, or remain in the custody of health care providers and eventually get destroyed,as per the retention period of medical records generally followed by hospitals in the country i.e. for 5 years for out-patient records, and 10 years for in patient records. Medico legal records are however retained permanently. This is applicable to health care setups with a proper medical record department only. There may be negligible to no health records maintained by private practitioners, at clinic setups and by rural healthcare setups. A typical Indian patient with varying literacy and awareness level usually does not retain his clinical documents either. Medical record is the property of the hospital and ‘not’ of the patient, clinical department or care provider/s. The patient also has no proprietary right on his own clinical record today. What the patient carries with him is the discharge summary of his clinical encounter along with his investigation reports and usually radiology films/images. Also, important clinical data is not available for research and for reference to aide in clinical decision support. Study of disease trends and statistical analysis of clinical nature also suffers.

Due to these and many more reasons, having an EHR of a patient with health records of each clinical encounter at varying healthcare setups, be it government or privately owned, is ‘actually’ a dream come true for India. In the coming years, EHR of an Indian patient may even be accessible by care providers of other countries and vice versa, especially with the boom in global medical tourism trends.

What are EHR Standards for India?

As per the EHR standards released in August 2013 by the Ministry of Health & Family Welfare, Government of India, ‘for creation of a true electronic health record of an individual it is imperative that all clinical records created by the various care providers that a person visits during his/her lifetime be stored in a central clinical data repository or at least be shareable through the use of interoperable standards. Adequate safeguards to ensure data privacy and security must strictly be adhered to at all times. Patients must have the privilege to verify the accuracy of their health data and gain access whenever they wish to do so’.2The EHR standards of India emphasize on ‘Patient’ as the authorized owner of his health data’. The standards aim to develop a system which would allow one to create, store, transmit or receive electronically, the ‘Electronic Protected Health Information(ePHI)’of a patient, using reliable media for data storage and transfer. EHRs can bring a patient’s complete health information together for supporting better clinical decisions, and more coordinated care amongst various care providers.

Vision for Interoperability with International HCIT Programs and Adoption of Universal HCIT standards

The EHR standards were formed after a thorough study and analysis of National EMR/EHR and Healthcare IT (HCIT) programs implemented in the world, mainly in countries like Canada, Australia, Austria, Denmark, England, Hong Kong, Netherlands, Singapore and Sweden. Country wise adoption of Healthcare IT standards and applicable ISO standards were also reviewed and referred to.

Vocabulary Standards i.e. standardized nomenclatures and code sets used universally, called Controlled Medical Vocabulary (CMV)have been adoptedin India’s EHR model to describe clinical problems and procedures, medications, and allergies, keeping in mind, a need of interoperability between EHRs of different countries,for a common understanding of clinical information of the patient, andfor continuity of care from one clinical facility to another. Universally accepted Content Exchange Standards are also being followed.

Linking National UID (AADHAR) and HCIT standards

These standards emphasize the use of National UID or AADHAR number as the primary or secondary Unique Health Identifier (UHID) of a patient visiting a healthcare facility. The AADHAR number will serve as the unique patient identifier for all healthcare organizations across the nation. The other ID, may be used to identify the patient within the organization and as a reference in its EMR system. The EHR standards also define the Healthcare IT (HCIT) Standards applicable for India, besides the inclusion of National UID or AADHAR number. So, going forward, the AADHAR number will act as the unique identifier for the EHR of an Indian citizen, which will be a longitudinal health record of a citizen’s lifespan with several clinical encounters in different care settings.

Standardization of Discharge Summary format

The EHR standards recommend that EMR/EHR’s being developed by software vendors and adopted by healthcare organizations must follow the format of Discharge Summary that the application will generate, as per one specified by the Medical Council of India, under regulation 3.1.

Data Exchange, Data Privacy and Security

These standards also recommend that IEEE 11073 health informatics standards and related ISO standards be used for interfacing the EMR/EHR with medical devices and personal healthcare devices for the purpose of clinical data exchange, retrieval, and storage, etc. The standards lay guidelines for hardware to be selected by healthcare organizations, software to be used for EMR/EHR design and development, and also recommend networking and connectivity medium for reliable, fast, secure exchange of healthcare data between individual EMRs, towards an integrated, single, EHR.

Whereas, the physical medical records will remain to be owned by the Healthcare Providers, the health data contained in them shall be owned by the patient himself as per the IT Act, 2000 for the definition of sensitive personal information (SPI) and personal information (PI). The standards also mandate all EMR/EHR applications to maintain fool-proof audit log of amendments done to the health record of a patient, if made. Further, the standards have detailed recommendations on ‘Data Privacy and Security’. But, in a nut shell, ‘Patients will have privileges to restrict access to and disclosure of individually identifiable health information and all recorded data will be available to care providers on an ‘as required on demand’ basis’1.

Minimum Data Sets in the EHR Reference Data Model

The standards enforce the use of digital signatures as per the reference framework for e-authentication called ‘e-pramaan’. They also contain a list of 18 patient identifiers which a progressive EMR/EHR application must have including the patient name, AADHAR number etc. These standards recommend Minimum Data Sets (MDS) as a part of its reference data model, which primarily includes data items to capture patient demographic information and emergency contact information, care provider information, encounter information, insurance information, reason for visit, patient history (present, past, personal, family, obstetrics and gynecology, surgical, immunization), allergy recordings, clinical examination, blood group, diagnosis recordings, investigation results, clinical summary, treatment plan for medication, procedure, investigation and referral etc., current clinical status and digital signature of care provider. The software vendor may provide additional fields for data capture in their EMR/EHRapplications.

EHR Standards on road to Integrated Indian Healthcare System

Software companies who are looking at implementing their Healthcare Information Systems (HIS), EMR or EHRapplications in India are working towards compliance with the EHR standards of India. Healthcare providers and organizations also, now, have a framework with guidelines, for effective implementation of these systems in their healthcare settings, right from choosing the right IT Infrastructure to selection of a modern HIS/EMR/EHR application with a futuristic design towards integrated healthcare for India. The basic idea of the EHR standards is to have a country wide rollout of EHR for all healthcare organizations and link it to the National UID of the patient (AADHAR). An article in Forbes India magazine stated that ‘with UID database residing in the cloud, even a rudimentary EHR linked to it and stored in the cloud along with critical information, say, about blood group, allergies, chronic illness, long term medication, etc. can go a long way not only in better healthcare delivery but even for gathering epidemiological data.’10 Connecting rural and urban healthcare delivery systems through UID and EHR standards seems like a magnanimous task for now, but if given aggressive timelines and adequate impetus of implementation, will surely see the foreseen success.

                                                                                 Author: Ranjeeta Basra Korgaonkar

References:

  1. ‎August 2013,’ Electronic Health Record Standards for India’, Ministry of Health & Family Welfare, Government of India.
  2.  April 2013, ‘Recommendations on Electronic Medical Records Standards in India’, EMR Standards Committee, constituted by an order of Ministry of Health & Family Welfare, Government of India and coordinated by FICCI on its behalf.

Website :

  1. MOHFW: http://mohfw.nic.in/WriteReadData/l892s/EHR%20Standards%20for%20India%20-%20August%202013-32630521.pdf
  2. MOHFW: http://mohfw.nic.in/WriteReadData/l892s/EMR%20Standards-v5%20Apr%202013-57137745.pdf
  3. Wikipedia: http://en.wikipedia.org/wiki/Electronic_health_record
  4. Health IT: http://www.healthit.gov/providers-professionals/ehr-interoperability
  5. EHR Intelligence: http://ehrintelligence.com/2013/08/20/how-ehr-standardization-improve-care-quality-patient-safety/
  6. MCI: http://www.mciindia.org/rules-and-regulation/Code%20of%20Medical%20Ethics%20Regulations.pdf
  7. HIMSS Analytics:http://www.himssanalytics.org/docs/WP_EMR_EHR.pdf
  8. Forbes India:http://forbesindia.com/blog/health/one-uid-one-ehr-beyond-cash-transfers-lpg-and-vote-bank-politics/#ixzz2i6mFpI5D
    1. ISO:https://www.iso.org/obp/ui/#iso:std:iso:18308:ed-1:v1:en
    2. HIMSS: www.himss.org/library/ehr/