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ELECTRONIC HEALTH RECORD (EHR)
STANDARDS FOR INDIA
FEBRUARY 2016
Presenter: Dr Sourav Goswami
Moderator: Dr Ashwini Kalantri
MGIMS, Sevagram
FRAMEWORK
Why EHR?
Context of development of EHR standards for India
Interoperability and standard
Guidelines
Data ownership of EHR
Data Privacy & security
National VS International scenario
Examples
References
WHY EHR???
“For a health record of an individual to be clinically
meaningful it needs to be from conception or birth, at
the very least”.
An Electronic Health Record (EHR) is a collection of
various medical records that get generated during any
clinical encounter or events.
Benefits of Electronic Medical
Records
Track data over time
Identify patients who are due for preventive
visits and screenings
Monitor how patients measure up to certain
parameters, such as vaccinations and blood
pressure readings
Improve overall quality of care in a practice
HIERARCHY
Medical Health Records
Electronic Medical records (EMR)
Electronic Health Records (EHR)


EHR Standards For India (2016)
The Union Health Ministry has notified the Electronic
Health Records (EHR) standards 2016 with an aim to
introduce a uniform system for creation and maintenance
of health records by healthcare providers.
The idea is that any person in the country can go to any
healthcare provider, medical practitioner or pharmacy
and access fully integrated health records in electronic
format , which is the vision for "efficient" 21st century
healthcare delivery.
EHR standards for India (2016)
contd…
With an objective to introduce a uniform standard based
system for creation and maintenance of EHRs by healthcare
providers, the Health Ministry notified EHR standards for India
in 2013.
With passage of time, EHR standards 2013 have been duly
revised in line with contemporary developments in
consultation with stakeholders. Accordingly, EHR standards
2016 document is notified and placed for adoption in IT
systems by healthcare institutions and providers across the
country
The ministry said while notifying the 2016 standards it was
understood that they will continue to evolve and will require
revision from time to time.
Interoperability & standards
Interoperability & standards
The set of standards outlined in this
document represents an incremental approach
to:
1. adopting standards, implementation
specifications;
2. criteria to enhance the interoperability,
functionality, utility, and security of
health information technology;
3. to support its widespread adoption.
It is to be kept in mind that these standards
need to be flexible and modifiable to adapt to
the demographic and resource variance
observed in India with its large population and
diverse culture.
Interoperability & standards
To achieve interoperability, information models
would need to be standardized into a consistent
representation.
To achieve interoperability at this level,
standardizing vocabularies, or mapping
between different vocabularies (using tools like
Unified Medical Language System (UMLS)) may
be necessary.
Standards at a glance
Standards at a glance
Standards at a glance
The goals of standards in electronic health
record systems are:
Promoting interoperability
Support the evolution and timely maintenance of adopted
standards
Promote technical innovation using adopted standards
Encourage participation and adoption by all vendors and
stakeholders
Keep implementation costs as low as reasonably possible
Consider best practices, experiences, policies and frameworks
To the extent possible, adopt standards that are modular and not
interdependent.
Guidelines
Hardware
Networking and connectivity
Software standards
Proposed Mobile Health Records
Guidelines for Hardware
   The IT hardware used should meet (and preferably be better than)
the optimal requirement given by the software (to be) used.
   The medical and IT hardware used must meet the relevant applicable
specifications from BIS, NEMA, ISO, CE, RoHS, EnergyStar, apart from
Medical and IT standards for the equipment.
   A backup or data preservation mechanism should be considered. Data
capacity should be planned to meet the storage requirement as per the
mandated rule/law.
   System redundancy at various levels (disk, power, network, etc.)
should be planned to meet the organizational system availability
requirement.
   Network and data security should be planned, implemented, and
periodically audited. Please see section on Security and Privacy for
requirements and functions to be supported and implemented.
   Hardware should be checked periodically for correctness and
completeness of operation expected from them. An appropriate
maintenance cycle should be planned and followed.
   Planned and expected Capacity and Quality requirement of the
organization should be met by the hardware used. Periodic updates and
Guidelines for Networking and Connectivity
  Should be able to harness any telecommunications-related connectivity
like the Internet, LAN, WAN, WAP, CDMA, GSM or even Cloud
Computing that will permit the various EMRs of an individual to be
integrated into a single lifelong electronic health record
  As far as practical and affordable, the connectivity medium chosen
should be reliable and fast enough to sustain a secure data exchange for
the period expected for transaction of records and data. The speed of the
connectivity medium should be chosen from among available options so as
to provide an acceptable user experience and not cause software/system
fault due to delays/noise/failure.
  Should be able to ensure that data exchange is performed in a secure
manner to ensure data validity and non-repudiability
  The data exchange must further ensure that data integrity is maintained
at all times
Guidelines for software standard
The software should
Conform to the specified standards
 Satisfy specified requirements
Be Interoperable
Should be able to ensure role based access control at all times
Should be able to support privacy, secrecy and audit trail
Possess advanced search, merge, and demerge functionality to
ensure that duplicates are robustly resolved
Should be able to support conception-to-current health records
of a person
Should be able to support digital archiving and retrieval of
health records after the death of a person for the total duration
as specified by Government of India from time to time
Guidelines for Proposed Mobile Health
Record
As patients move around the healthcare system there is a need to
carry essential information to ensure quality healthcare which will
give their treating clinician basic information viz., health condition,
drug/allergy information etc. CCR standard XML file format, with
demographics, insurance info, problem list/diagnoses, medications,
allergy and alerts, vital signs, and lab results, consultation reports,
hospital discharge and operative reports and investigative and
diagnostic results (e.g. ECG reports, tread mill test results,
biochemistry results, histopathological findings, ultrasound findings,
etc.) kept current and accurate by a person’s healthcare team
(nurses, doctors and pharmacists) which includes the patient.
Data Ownership of EHR
The physical or electronic records, which are owned by
the healthcare provider. These are held in trust on
behalf of the patient, and
The contained data which are the sensitive personal
data (Passwords, Financial information such as bank account or credit card
or debit card or other payment instrument details; Physical, psychological and
mental health condition; Sexual orientation; Medical/clinical records and
history; Biometric information) of the patient is owned by the
patient himself/herself.
The healthcare provider will have the privilege to
change/append/modify any record in relation to the
health care of the patient as necessary with a complete
documented trail of such change. No alteration of the
previously saved data will be permitted.
Disclosure of information
For use for treatment, payments and other healthcare
operations: In all such cases, a general consent must be taken
from the patient or next of kin, etc. as defined by applicable
laws by MCI.
Fair use for non-routine and most non-health care purposes: a
specific consent must be taken from the patient; format as
defined by MCI.
Certain national priority activities, including
notifiable/communicable diseases, will be specified for which
health information may be disclosed to appropriate authority
as mandated by law without the patient's prior authorization
Responsibilities of any healthcare provider
Protect and secure the stored health information
While providing patient information, remove patient identifying
information , if it is not necessary to be provided
Will ensure that there are appropriate means of informing the
patient of policies relating to his/her rights to health record
privacy
Document all its privacy policies and ensure that they are
implemented and followed. This will include:
Develop internal privacy policies
Designate a privacy officer (preferably external, may be
internal) who will be responsible for implementing privacy
policies, audit and quality assurance
Provide privacy training to all its staff
Patient’s privilege
Patients will have the privilege to ask for a copy of their
health records held by a healthcare organization.
Patients will have the privilege to request a healthcare
organization that holds their health records, to withhold
specific information that he/she does not want disclosed
to other organizations or individuals.
Patient can demand information from a healthcare
provider on the details of disclosures performed on the
patients health records.
Electronic Health Records
Preservation
All records must compulsorily be preserved and not destroyed during
the life- time of the person, ever.
It is however preferred that the records are never be destroyed or
removed permanently. Because:
 The health of the blood relatives and natural descendants of the
person can be strongly influenced by the health of the person and on-
demand access to these may prove to be hugely useful in the maintenance
of the health of the the relations.
 Furthermore, analysis of health data of all persons is expected to
greatly benefit in the understanding of health, disease processes and the
amelioration thereof.
 With rapid decline in costs of data archiving coupled with the ability to
store more and more data that may be readily accessible, continued
maintenance of such data is not expected to lead to any big impact on the
overall system maintenance and use.
DATA PRIVACY & SECURITY
Any health record system requires safeguards to ensure
the data is available when needed and that information is
not used, disclosed, accessed, altered, or deleted
inappropriately while being stored or transmitted.
The Security Standards work together with the Privacy
Standards to establish appropriate controls and
protections
Technical standards:
 Access control;
 Access privilege;
 Audit log;
 Integrity;
 Authentication;
 Encryption
International scenario
In 2015, EHRs were created for 91% of Canadians, and
91,000 clinicians were using EHR systems in their work.
In 2001, England started a national initiative called the
"National Plan for IT” for modernizing its healthcare
system, covering 96 % of population
In Germany, about 90% of physicians in private practice
are using EHR systems. Patient privacy has been given
adequate attention in the initiative. The patient can
decide to hide or block any entry in the health record
Indian Scenario
India has a mixed system of healthcare consisting of a large
number of hospitals run by the Central Government and State
Government as well as the private sector. In general, the level of
use of ICT in the healthcare sector in the country has been
lower in comparison to other countries.
Some of the corporate hospitals in India, such as Max Health,
Apollo, Sankara Nethralaya,Narayan Hridayalaya, Fortis, etc.,
have implemented integrated ICT(Information Communication
Technology) systems in place, covering all aspects, i.e., registration
and billing as well as laboratory and clinical data.
Go from Paper to Digital
Have patients' information at your finger tips
THANK YOU
References
 Ministry of Health and family welfare, Government of India. Electronic
Health Record (EHR) Standards for India 2016. [cited at 2017 Feb 27].
Available from:
http://mohfw.nic.in/WriteReadData/l892s/2857976581461059607.pdf
 Srivastava SK. Adoption of Electronic Health Records: A Roadmap for India.
Healthcare Informatics Research. 2016;22(4):261-269.
 India Ministry of Health & Family Welfare [Internet] New Delhi: Ministry of
Health & Family Welfare. [cited at 2017 Feb 27]. Available from:
http://mohfw.gov.in.
 Canada Health Infoway. Annual report 2014-2015: the path of progress.
Toronto: Canada Health Infoway; 2015.
 National Health Service [Internet] London: National Health Service [cited at
2017 Feb 27]. Available from: http://digital.nhs.uk.
 Parliament Office of Science and Technology. Electronic Health Records
[Internet] London: Parliament Office of Science and Technology; 2016.
[cited at 2017 Feb 27]. Available from:
http://researchbriefings.parliament.uk/ResearchBriefing/Summary/POST-PN-0
.
 German Federal Ministry of Health. The electronic health card [Internet]
Bonn: Federal Ministry of Health; c2016. [cited at 2017 Feb 72]. Available
from: http://www.bmg.bund.de/en/health/the-electronic-health-card.html.

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Electronic Health Record (EHR)

  • 1. ELECTRONIC HEALTH RECORD (EHR) STANDARDS FOR INDIA FEBRUARY 2016 Presenter: Dr Sourav Goswami Moderator: Dr Ashwini Kalantri MGIMS, Sevagram
  • 2. FRAMEWORK Why EHR? Context of development of EHR standards for India Interoperability and standard Guidelines Data ownership of EHR Data Privacy & security National VS International scenario Examples References
  • 3. WHY EHR??? “For a health record of an individual to be clinically meaningful it needs to be from conception or birth, at the very least”. An Electronic Health Record (EHR) is a collection of various medical records that get generated during any clinical encounter or events.
  • 4. Benefits of Electronic Medical Records Track data over time Identify patients who are due for preventive visits and screenings Monitor how patients measure up to certain parameters, such as vaccinations and blood pressure readings Improve overall quality of care in a practice
  • 5.
  • 6. HIERARCHY Medical Health Records Electronic Medical records (EMR) Electronic Health Records (EHR)  
  • 7. EHR Standards For India (2016) The Union Health Ministry has notified the Electronic Health Records (EHR) standards 2016 with an aim to introduce a uniform system for creation and maintenance of health records by healthcare providers. The idea is that any person in the country can go to any healthcare provider, medical practitioner or pharmacy and access fully integrated health records in electronic format , which is the vision for "efficient" 21st century healthcare delivery.
  • 8. EHR standards for India (2016) contd… With an objective to introduce a uniform standard based system for creation and maintenance of EHRs by healthcare providers, the Health Ministry notified EHR standards for India in 2013. With passage of time, EHR standards 2013 have been duly revised in line with contemporary developments in consultation with stakeholders. Accordingly, EHR standards 2016 document is notified and placed for adoption in IT systems by healthcare institutions and providers across the country The ministry said while notifying the 2016 standards it was understood that they will continue to evolve and will require revision from time to time.
  • 10. Interoperability & standards The set of standards outlined in this document represents an incremental approach to: 1. adopting standards, implementation specifications; 2. criteria to enhance the interoperability, functionality, utility, and security of health information technology; 3. to support its widespread adoption. It is to be kept in mind that these standards need to be flexible and modifiable to adapt to the demographic and resource variance observed in India with its large population and diverse culture.
  • 11. Interoperability & standards To achieve interoperability, information models would need to be standardized into a consistent representation. To achieve interoperability at this level, standardizing vocabularies, or mapping between different vocabularies (using tools like Unified Medical Language System (UMLS)) may be necessary.
  • 12. Standards at a glance
  • 13. Standards at a glance
  • 14. Standards at a glance
  • 15. The goals of standards in electronic health record systems are: Promoting interoperability Support the evolution and timely maintenance of adopted standards Promote technical innovation using adopted standards Encourage participation and adoption by all vendors and stakeholders Keep implementation costs as low as reasonably possible Consider best practices, experiences, policies and frameworks To the extent possible, adopt standards that are modular and not interdependent.
  • 16. Guidelines Hardware Networking and connectivity Software standards Proposed Mobile Health Records
  • 17. Guidelines for Hardware    The IT hardware used should meet (and preferably be better than) the optimal requirement given by the software (to be) used.    The medical and IT hardware used must meet the relevant applicable specifications from BIS, NEMA, ISO, CE, RoHS, EnergyStar, apart from Medical and IT standards for the equipment.    A backup or data preservation mechanism should be considered. Data capacity should be planned to meet the storage requirement as per the mandated rule/law.    System redundancy at various levels (disk, power, network, etc.) should be planned to meet the organizational system availability requirement.    Network and data security should be planned, implemented, and periodically audited. Please see section on Security and Privacy for requirements and functions to be supported and implemented.    Hardware should be checked periodically for correctness and completeness of operation expected from them. An appropriate maintenance cycle should be planned and followed.    Planned and expected Capacity and Quality requirement of the organization should be met by the hardware used. Periodic updates and
  • 18. Guidelines for Networking and Connectivity   Should be able to harness any telecommunications-related connectivity like the Internet, LAN, WAN, WAP, CDMA, GSM or even Cloud Computing that will permit the various EMRs of an individual to be integrated into a single lifelong electronic health record   As far as practical and affordable, the connectivity medium chosen should be reliable and fast enough to sustain a secure data exchange for the period expected for transaction of records and data. The speed of the connectivity medium should be chosen from among available options so as to provide an acceptable user experience and not cause software/system fault due to delays/noise/failure.   Should be able to ensure that data exchange is performed in a secure manner to ensure data validity and non-repudiability   The data exchange must further ensure that data integrity is maintained at all times
  • 19. Guidelines for software standard The software should Conform to the specified standards  Satisfy specified requirements Be Interoperable Should be able to ensure role based access control at all times Should be able to support privacy, secrecy and audit trail Possess advanced search, merge, and demerge functionality to ensure that duplicates are robustly resolved Should be able to support conception-to-current health records of a person Should be able to support digital archiving and retrieval of health records after the death of a person for the total duration as specified by Government of India from time to time
  • 20. Guidelines for Proposed Mobile Health Record As patients move around the healthcare system there is a need to carry essential information to ensure quality healthcare which will give their treating clinician basic information viz., health condition, drug/allergy information etc. CCR standard XML file format, with demographics, insurance info, problem list/diagnoses, medications, allergy and alerts, vital signs, and lab results, consultation reports, hospital discharge and operative reports and investigative and diagnostic results (e.g. ECG reports, tread mill test results, biochemistry results, histopathological findings, ultrasound findings, etc.) kept current and accurate by a person’s healthcare team (nurses, doctors and pharmacists) which includes the patient.
  • 21. Data Ownership of EHR The physical or electronic records, which are owned by the healthcare provider. These are held in trust on behalf of the patient, and The contained data which are the sensitive personal data (Passwords, Financial information such as bank account or credit card or debit card or other payment instrument details; Physical, psychological and mental health condition; Sexual orientation; Medical/clinical records and history; Biometric information) of the patient is owned by the patient himself/herself. The healthcare provider will have the privilege to change/append/modify any record in relation to the health care of the patient as necessary with a complete documented trail of such change. No alteration of the previously saved data will be permitted.
  • 22. Disclosure of information For use for treatment, payments and other healthcare operations: In all such cases, a general consent must be taken from the patient or next of kin, etc. as defined by applicable laws by MCI. Fair use for non-routine and most non-health care purposes: a specific consent must be taken from the patient; format as defined by MCI. Certain national priority activities, including notifiable/communicable diseases, will be specified for which health information may be disclosed to appropriate authority as mandated by law without the patient's prior authorization
  • 23. Responsibilities of any healthcare provider Protect and secure the stored health information While providing patient information, remove patient identifying information , if it is not necessary to be provided Will ensure that there are appropriate means of informing the patient of policies relating to his/her rights to health record privacy Document all its privacy policies and ensure that they are implemented and followed. This will include: Develop internal privacy policies Designate a privacy officer (preferably external, may be internal) who will be responsible for implementing privacy policies, audit and quality assurance Provide privacy training to all its staff
  • 24. Patient’s privilege Patients will have the privilege to ask for a copy of their health records held by a healthcare organization. Patients will have the privilege to request a healthcare organization that holds their health records, to withhold specific information that he/she does not want disclosed to other organizations or individuals. Patient can demand information from a healthcare provider on the details of disclosures performed on the patients health records.
  • 25. Electronic Health Records Preservation All records must compulsorily be preserved and not destroyed during the life- time of the person, ever. It is however preferred that the records are never be destroyed or removed permanently. Because:  The health of the blood relatives and natural descendants of the person can be strongly influenced by the health of the person and on- demand access to these may prove to be hugely useful in the maintenance of the health of the the relations.  Furthermore, analysis of health data of all persons is expected to greatly benefit in the understanding of health, disease processes and the amelioration thereof.  With rapid decline in costs of data archiving coupled with the ability to store more and more data that may be readily accessible, continued maintenance of such data is not expected to lead to any big impact on the overall system maintenance and use.
  • 26. DATA PRIVACY & SECURITY Any health record system requires safeguards to ensure the data is available when needed and that information is not used, disclosed, accessed, altered, or deleted inappropriately while being stored or transmitted. The Security Standards work together with the Privacy Standards to establish appropriate controls and protections Technical standards:  Access control;  Access privilege;  Audit log;  Integrity;  Authentication;  Encryption
  • 27. International scenario In 2015, EHRs were created for 91% of Canadians, and 91,000 clinicians were using EHR systems in their work. In 2001, England started a national initiative called the "National Plan for IT” for modernizing its healthcare system, covering 96 % of population In Germany, about 90% of physicians in private practice are using EHR systems. Patient privacy has been given adequate attention in the initiative. The patient can decide to hide or block any entry in the health record
  • 28. Indian Scenario India has a mixed system of healthcare consisting of a large number of hospitals run by the Central Government and State Government as well as the private sector. In general, the level of use of ICT in the healthcare sector in the country has been lower in comparison to other countries. Some of the corporate hospitals in India, such as Max Health, Apollo, Sankara Nethralaya,Narayan Hridayalaya, Fortis, etc., have implemented integrated ICT(Information Communication Technology) systems in place, covering all aspects, i.e., registration and billing as well as laboratory and clinical data.
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  • 36. Go from Paper to Digital Have patients' information at your finger tips THANK YOU
  • 37. References  Ministry of Health and family welfare, Government of India. Electronic Health Record (EHR) Standards for India 2016. [cited at 2017 Feb 27]. Available from: http://mohfw.nic.in/WriteReadData/l892s/2857976581461059607.pdf  Srivastava SK. Adoption of Electronic Health Records: A Roadmap for India. Healthcare Informatics Research. 2016;22(4):261-269.  India Ministry of Health & Family Welfare [Internet] New Delhi: Ministry of Health & Family Welfare. [cited at 2017 Feb 27]. Available from: http://mohfw.gov.in.  Canada Health Infoway. Annual report 2014-2015: the path of progress. Toronto: Canada Health Infoway; 2015.  National Health Service [Internet] London: National Health Service [cited at 2017 Feb 27]. Available from: http://digital.nhs.uk.  Parliament Office of Science and Technology. Electronic Health Records [Internet] London: Parliament Office of Science and Technology; 2016. [cited at 2017 Feb 27]. Available from: http://researchbriefings.parliament.uk/ResearchBriefing/Summary/POST-PN-0 .  German Federal Ministry of Health. The electronic health card [Internet] Bonn: Federal Ministry of Health; c2016. [cited at 2017 Feb 72]. Available from: http://www.bmg.bund.de/en/health/the-electronic-health-card.html.