Comments on Draft Electronic Health Records Standards

To,
Ministry of Health and Family Welfare,
Room 307 D,
Nirman Bhavan,
New Delhi 110108

Subject: Comments on the Electronic Health Record (EHR) Standards of India

The Electronic Health Record (EHR) Standards (hereinafter “EHR Standards”) were publicly circulated on March 18, 2016 seeking comments and views from stakeholders and the general public. Having reviewed the EHR Standards and referred to other robust standards dealing with the same subject matter, we wish to submit the following comments on the EHR Standards.

Standards and Interoperability

The EHR Standards state that the "primary aim of interoperability standards is to ensure syntactic (structural) and semantic (inherent meaning) interoperability of data amongst systems at all times" [1]. It is mentioned that set of standards outlined in this document represents an incremental approach to adopting standards and that they need to be flexible and modifiable to adapt to the demographic and resource diversity in India.

Comments:

1. The EHR Standards make a reference to syntactic and semantic interoperability without really defining these terms or stipulating clear steps for how they may be achieved. It is suggested that these terms are clearly defined. Syntactic interoperability can be defined as ensuring the preservation of the clinical purpose of the data during transmission among healthcare systems. Similarly, semantic interoperability can defined as enabling multiple systems to interpret the information that has been exchanged in a similar way through pre-defined shared meaning of concepts [2].
2. Inadequate human resource capacity remains a critical challenge to the adoption of e-health standards. The WHO and ITU eHealth Strategy Toolkit [3] recommends the development of effective health ICT workforce, capable of designing, building, operating and supporting e-health services. This workforce could participate in standards development, as well as the localization of international standards to fit a country's specific need. The EHR Standards should also include mechanisms and solutions to address these issues.

Ownership of Data

The physical or electronic records, which are generated by the healthcare provider are held in trust by them on behalf of the patient [4]. It is stated that the contained data which is sensitive personal data or personal information of the patient as per the Information Technology Act, 2000 is owned by the patients, however the medium for storage or transmission of such data is owned by the healthcare provider.

Comments:

1. Currently, the EHR Standards state that the contained data which are the sensitive personal data of the patient is owned by the patient. While medical records and history is included within the scope of sensitive personal data under the Information Technology Act, 2000, the definition of "Personal Health Information" under the EHR Standards is more expansive. Therefore, it is recommended that all Personal Health Information is deemed to be owned by the patient.
2. Currently, the EHR Standards do not clearly specify the bodies and individuals who would be subject to the requirements under this document. A definition similar to that of "covered entities" under the US Health Insurance Portability and Accountability Act (HIPAA) could be used [5].

Privileges of Patient

Currently, the privileges of the patient include the rights to inspect and view their medical records. Further, the patient can request a healthcare organization that stores/maintains their medical records, to withhold specific information that they do not want disclosed to other

organizations or individuals. Also, patients can demand information from a healthcare provider on the details of disclosures performed on the patient's medical records [6].

Comments:

1. Currently, the EHR Standards only refer to "medical records" as being available for inspection and review of the patients. This should be expanded to also include information about enrollment, payment, claims adjudication, case or medical management record systems maintained by or for a health plan; or Other records that are used, to make decisions about individuals by healthcare providers or other bodies [7].
2. The EHR standards do not currently stipulate that the upon request by a patient, healthcare providers must exercise timeliness in providing the information to them. A time-limit such 30 calendar days should be clearly stated within which the healthcare provider must process the request.
3. The right of patients to request information from a healthcare provider on the details of disclosures should include within its scope the rights to receive the date of the disclosure; the name and address of the entity or person who received the information; a brief description of the medical information disclosed; and; a brief summary of the purpose of the disclosure [8].
4. A right to seek amendment of the one's medical records should also be provided to patients in cases where the information is incomplete.

Patient Identifying Information

Under the Standards, Personal identifiers include the following: Name, Address (all geographic subdivisions smaller than street address, and PIN code) All elements (except years) of dates related to an individual (including date of birth, date of death, etc.), Telephone, cell (mobile) phone and/or Fax numbers, Email address, Bank Account and/or Credit Card Number, Medical record number, Health plan beneficiary number, Certificate/license number, Any vehicle or other any other device identifier or serial numbers, PAN number, Passport number, AADHAAR card, Voter ID card, Fingerprints/Biometrics, Voice recordings that are non-clinical in nature, Photographic images and that possibly can individually identify the person, Any other unique identifying number, characteristic, or code [9].

Comments:

The above mentioned list is not adequate and exhaustive such as the definition and scope of Protected Health Information under the HIPAA [10]. The following identifiers must be included within the scope of Patient Identifying Information: Device identifiers and serial numbers, Web Universal Resource Locators (URLs), Internet Protocol (IP) address numbers.

Disclosure of Protected/Sensitive Information

The EHR Standards state that disclosure of protected/sensitive information for use in treatment, payments and other healthcare operations must be only done after obtaining a general consent of the patient. On the other hand, disclosures for for non-routine and most non-health care purposes must be done only after obtaining the specific consent of the patient. Only for certain specified national priority activities, such as notifiable/communicable diseases, it is stated that "the health information may be disclosed to appropriate authority as mandated by law without the patient's prior authorization."

Comments:

1. The terms "specific consent" and "general consent" need to be clearly defined.
2. In cases of disclosures for for non-routine and most non-health care purposes, a written authorisation should be mandatory. It should be clearly specified that a healthcare provider may not condition treatment, payment, enrollment, or benefits eligibility on an individual granting an authorization.
3. There is confusion due to the use of numerous terms such as "health information", "protected health information", "sensitive personal data", "personal information" and "protected/sensitive information" in the EHR Standards for the same purpose. Some of these above terms are defined while the others are not. In order to remove the ambiguity caused due to this, it is recommended that the term "protected health information" is used throughout the document.
4. All bodies dealing with medical data should be required to abide by the principle of "data minimisation" in use and disclosure. They must take reasonable efforts to use, disclose, and request only the minimum amount of protected health information needed to accomplish the intended purpose of the use, disclosure, or request.
5. For internal uses, healthcare providers and other entities must develop and implement policies and procedures that restrict access and uses of protected health information based on the specific roles of the members of their workforce.

Amber Sinha,
Centre for Internet and Society,
No. 194, 2nd 'C' Cross,
Domlur, 2nd Stage,
Bengaluru, 560071