Tuesday, June 4, 2019

Professional Education for Digital Health


The term digital health is rooted in eHealth, which is defined as “the use of information and communications technology in support of health and health-related fields”. Mobile health (mHealth) is a subset of eHealth and is defined as “the use of mobile wireless technologies for public health”.
The newly proposed Global Strategy for Digital Health from the WHO is trying to define Digital Health as “the field of knowledge and practice associated with any aspect of adopting digital technologies to improve health, from inception to operation.”
Digital health interventions are applied within a country context and a health system, and their implementation is made possible by a number of factors. These include:

     (i)            the health domain area and associated content;
   (ii)            the digital intervention itself (i.e. the functionality provided);
 (iii)            the hardware, software and communication channels for delivering the digital health intervention; and, mediated within
 (iv)            a foundational layer of the ICT and enabling environment, characterized by the country infrastructure, leadership and governance, strategy and investment, legislation and policy compliance, workforce, standards and interoperability, and common services and other applications.

The National Health Policy 2017 (NHP-2017) of India correctly identified the need for creating many new institutions like the National Digital Health Authority (NDHA). Also, Health informatics education must be embedded as an integral part for health and hospital management. That will ensure a smooth adoption of digital health in India. India will then be recognized as a significant global player in digital health.
India has hosted the 4th Global Digital Health Partnership Summit and the International Digital Health Symposium in the last week of February 2019. This also shows the commitment of India towards strengthening Digital Health Globally. Here the “Delhi Declaration” was adopted to accelerate and implement the appropriate Digital Health interventions to improve health of the population at national and sub-national levels, as appropriate according to national context.

Soon after, on 16th April 2019, the World Health Organization (WHO) has released its recommendations of ten ways that countries can use digital technologies that people can improve their lives and essential services. Therefore, there is an imminent need for people, trained in digital health management, who can confidently handle a multitude of software services and help medical professionals, hospitals, healthcare organizations and common people. Courses on digital health are very new even globally and the career opportunities for early entrants are enormous.

Here I propose a 2-day or 12-hour interactive modular course for initiating health professional educators and administrators to the concepts and practice of digital health. I have been offering this course on-site, with suitable customization according to the needs of the institutes.

Course Objectives and Competencies


References
  1.  Sarbadhikari SN, Sood JM. Gamification for nurturing healthy habits. Natl Med J India 2018; 31: 253-4 / Sarbadhikari SN, Sood JM. Gamification for nurturing healthy habits. Natl Med J India Available from: http://www.nmji.in/text.asp?2018/31/4/253/258236
  2. Sarbadhikari SN, Will Health Informatics gain its rightful place for ushering in Digital India?, Indian Journal of Community Medicine, 2018, 43 (2): 126–127.
  3. Sarbadhikari SN & Srinivas M, Health Informatics and Health Information Management, In, Gyani G & Thomas A, Eds, Handbook of Healthcare Quality and Patient Safety, Jaypee, New Delhi, 2nded, 2016, Sec. 4, Ch. 17: 206-216.
  4. Sarbadhikari SN, Medical Informatics: A Key Tool to Support Clinical Research and Evidence-based Medical Practice (Ch 15), In, Babu AN, Ed, Clinical Research Methodology and Evidence-based Medicine, 2nd Ed, 2015: 179-191.
  5. Balsari S, Fortenko A, Blaya JA, Gropper A, Jayaram M, Matthan R, Sahasranam R, Shankar M, Sarbadhikari SN, Bierer BE, Mandl KD, Mehendale S and Khanna T. Re-imagining health data exchange: An API-enabled roadmap for India. J Med Internet Res [Impact Factor 4.7], 2018. doi:10.2196/10725.
  6. Ministry of Health and Family Welfare, Government of India, National Health Policy 2017. Available from: https://www.nhp.gov.in//NHPfiles/national_health_policy_2017.pdf
  7. Sarbadhikari SN. Digital health in India – As envisaged by the National Health Policy (2017). BLDE Univ J Health Sci 2019;4: [In Press]
  8. Sarbadhikari SN. Available from: https://blog.hcitexpert.com/2018/04/how-can-digital-health-be-implemented-in-NHP2017-Prof-Supten-Sarbadhikari.html - republished with permission from: http://supten.blogspot.com/2018/03/how-can-digital-health-be-implemented.html
  9. National Health Portal, Ministry of Health and Family Welfare, Government of India, EHR Standards. Available from: https://www.nhp.gov.in/ehr-standards-helpdesk_ms
  10. Ministry of Health and Family Welfare, Government of India and World Health Organization, India. Available from: https://www.gdhpindia.org/
  11. Global Digital Health Partnership, Delhi Declaration, Available from: https://s3-ap-southeast-2.amazonaws.com/ehq-production-australia/25eb0facd90ee547c03071b005807288dbeac40b/documents/attachments/000/099/429/original/GDHP-Delhi_Declaration_Final.pdf?1551307009
  12. World Health Organization; WHO guidelinerecommendations on digital interventions for health system strengthening. Geneva: 2019. Available from: https://apps.who.int/iris/bitstream/handle/10665/311941/9789241550505-eng.pdf


Saturday, January 19, 2019

“National” in my life!


After completing my +2 from St. Lawrence High School, I got admission to Calcutta National Medical College in 1984. Our classes started on the auspicious occasion of Teachers’ Day viz., 5th September.
During my college years, I was fortunate to become the Senior Class Assistant in Physiology and Junior Class Assistant in OBG. Apart from that I also used to participate and conduct quizzes, and, conduct many perpendicular events during AGON. Along with Anindya Chaudhuri, I had represented our college in the very first Quiz Time (1985) conducted by Siddharth Basu in Door Darshan.
By the time we passed out, by July 1989, and then completed our internship, by July 1990, most of us were sure of our possible future careers.
Although I did house job (junior residency) in General (Internal) Medicine from August 1990 to July 1991, that discipline was my seventh career option! Somehow or other I felt that those twelve months were the best in my life. Later on I penned down that experience in a booklet – “হাসপাতালে একবছর” from মনফিকরা (July 2016).
Psychiatry was higher in my option list so I went to the Central Institute of Psychiatry, Kanke, Ranchi for junior residency during August – September 1991.
However, my topmost option was making a career in medical informatics. Unfortunately, in the early 90s, there was no training available for informatics in India. The foreign institutes that I wrote to wanted me to know the basics of computers. So I was thinking of getting enrolled in NIIT.
Meanwhile, the School of Biomedical Engineering, Institute of Technology, Banaras Hindu University, (then IT-BHU, now IIT-BHU), Varanasi was offering Senior Research Fellowships to MBBS graduates for pursuing PhD in Biomedical Engineering. Fortunately, I was selected to join the institute in October 1991 and got registered for the PhD from the session of March 1992. I could choose my PhD topic related to development of an (artificial neural network based) clinical decision support system for depression.
During this period (March 1992 – March 1995), I once came to visit our Alma Mater and met many of our teachers. One of the teachers whom I met, used to love me a lot, especially since Amit Behl and myself had represented our college twice – in the 4th and 5th years, in the Nestle Pediatric Quiz. He asked me that since now I am pursuing PhD in Biomedical Engineering, what will I do after that? I answered that I don’t know. I was shocked by his response to my answer. Generally a mild spoken person, he got very angry and told me that I should have never chosen a career where the future is uncertain!
I submitted my PhD thesis in March 1995 and was invited to write a Guest Editorial for JIMA (Journal of the Indian Medical Association). I wrote in May 1995 [Vol. 93(5): pp.165-6. PubMed PMID: 8834135] Medical informatics – are the doctors ready?
Meanwhile I joined the Machine Intelligence Unit of Indian Statistical Institute in Calcutta as a Research Associate in a CSIR project under Prof. Sankar K Pal. Subsequently, I also did general practice in Durgapur for about a year and half, while my better half Dr. Anindya was a Medical Officer in CRPF, posted in Durgapur. I did a couple of short term contract jobs with South Eastern Railways and Bankura Sammilani Medical College during 1998-99.
The first formal academic job that I got was in Sikkim Manipal University from January 2000 I had joined as Assistant Professor in Biophysics in the department of Physiology. I was fortunate to teach the first batches of both MBBS (2001-02) and B.Tech (1997-98) – for the latter an elective in the 8th Semester on Neuro-fuzzy computing. I was also the first Coordinator of the Distance Education Directorate there.
From there I joined as the first faculty member (Assistant Professor) of the School of Medical Science and Technology (SMST) in IIT Kharagpur in August 2002. Then I joined the Amrita University, Coimbatore in July 2004 as Associate Professor and started two courses – M.Sc. (Medical Informatics) in 2005 (the first of its kind in India) and M.Tech (BME) in 2007. In 2008 I became the Founding Chair of Biomedical Informatics in PSG Institute of Medical Sciences and Research, Coimbatore. There I started offering online courses on Health Informatics and had more students from abroad than from India.
During 2011-12 I became a Visiting Professor in Health Informatics in Bangladesh, with the support of the Rockefeller Foundation, for starting a Masters Course in Health Informatics there.
From January 2013, I joined as the first Project Director of the Centre for Health Informatics, National Health Portal, under the Ministry of Health and Family Welfare, Government of India. Apart from developing the National Health Portal from scratch, I was also instrumental in coordinating the eHealth activities. I have been a member of the EHR Standards Committee since 2010. I was also the Chairperson for revising the Concept Note on the proposed National eHealth Authority of India. Consequently, the National Health Policy of 2017 clearly mentioned the setting up of the National Digital Health Authority to facilitate the adoption of Digital Health in India. On another note I have also been associated with the inclusion Software as a Medical Device in the Medical Devices Act of 2017. I have also been actively associated with the Bureau of Indian Standards for adopting and developing Standards for Health Informatics and Active Assisted Living. In other words, the “National” of my college is still inspiring me to undertake many activities of “National” importance.
In August 2017, I briefly returned to academics as Dean (Academics and Student Affairs) and Professor (Health Informatics) in the International Institute of Health Management Research, Delhi.
I have been appointed to the Board of Governors of the Washington Medical Science Institute, Saint Lucia, English Caribbean. I am also IMA Honorary Professor (2017-20) and Distinguished Fellow, HITLAB. I am a Fellow and Faculty of PSG-FAIMER Regional Institute, and have been Chair of HL7 India (2011-13), and, President of the Indian Association for Medical Informatics (IAMI – 2016). I’m a Founder Member of HL7 FHIR Foundation.
Now I am an independent consultant on Digital Health Standards and look forward to reinforcing the Digital Health Activities in India and elsewhere.

Monday, July 16, 2018

The Evolving Digital Health Landscape in India

Abstract

The journey of India towards Digital Health had begun in the right earnest, under the initiatives of the then Ministry of Information Technology, during 2002-03, with the publication of the ITIH (Information Technology Infrastructure fro Health). A major thrust has been received through the National Health Policy 2017 (NHP-2017) of India that has correctly identified the need for creating many new institutions like the National Digital Health Authority (NDHA).  The very first job for the proposed NDHA should be to formulate a robust National Digital Health Strategy / Policy, in consultation with all the stakeholders. Health informatics education must be embedded as an integral part for all health professional education, including health and hospital management. That will ensure a smooth adoption of digital health in India.
While the NHP-2017 had talked about setting up the Digital Health Ecosystem by establishing the National Digital Health Authority (NDHA), the proposed Bill, enabling the formation of NDHA, Digital Information Security in Healthcare Act (DISHA) has already sought public comments (Apr '18).
Also, pertinently, WHO, in the 71st World Health Assembly held recently (May '18), has adopted the Digital Health Resolution, initiated by India, thereby underlining the commitment of India towards Digital Health adoption.

Key Words: Digital Health; Digital India; National Health Policy 2017; Implementation; Digital Information Security in Healthcare Act (DISHA)

Twelve Landmark Steps of the Indian DH Landscape:

1. ITIH (Information Technology Infrastructure for Health) Framework published by MIT, GoI: 2003. This document stressed on the three pillars for success – regulatory / legislator framework, Standards and Education (Capacity Building).
2. National Knowledge Commission Recommendations for Digital Health (2009). Here recommendations were made for having a Health Information Network and a National Health Information Authority.
3. Formation of EHR Standards Committee by the Ministry of Health and Family Welfare, Government of India (MoHFW): September 2010. This Committee was the first to bring out comprehensive standards for health information exchange, so that electronic health records (EHRs) can be interoperable right from the beginning.
4. Setting up of the Centre for Health Informatics (National Health Portal): January 2013. This centre was responsible for developing the National Health Portal for the MoHFW and carry out all the eHealth related activities for the MoHFW.
5. 1st Edition of EHR Standards published: August 2013. This was the logical culmination of the work done by the EHR Standards Committee.
6. India takes Country Membership of SNOMED-CT: March 2014. This was a great achievement as India could foresee the importance of Clinical Terminology Systems for the exchange of health information.
7. Publication of the Core Curriculum for Health Information Management (HIM) by MoHFW, GoI: 2015. This was a very significant initiative on the part of MoHFW to develop forward-looking curricula for allied health professionals. The role and career prospects of HIM professionals have been detailed in great outline here.
8. National Level Stakeholder Consultation for the proposed National eHealth Authority: 4th April 2016
9. 2nd Edition of EHR Standards published: December 2016. This was another useful step for updating the Standards recommendations following the advances in Standards, and, also to ensure that SNOMED CT is a recommended standard as India is now a country member for SNOMED CT.
10. National Health Policy (3rd Edition): February 2017. For the first time the National Health Policy of India laid stress on eHealth and Digital Health in a formal way so as to develop a supporting ecosystem.
11. Digital Information Security in Healthcare Act (DISHA) – draft Bill put in public domain inviting comments till 21st April 2018. Currently the comments are being reconciled and the Bill is likely to be placed in the Parliament soon. The very first job for the proposed NDHA should be to formulate a robust National Digital Health Strategy / Policy, in consultation with all the stakeholders. Health informatics education must be embedded as an integral part for all health professional education, including health and hospital management. That will ensure a smooth adoption of digital health in India.
12. The adoption of the global Digital Health Resolution (initiated by India) in the 71st World Health Assembly, Geneva in May 2018. This endorsed the commitment of India towards Digital Health adoption.

Some other related happenings

Another significant achievement in a related area has been Telemedicine, initially propelled by the Department of Space / ISRO through the Edusat during the turn of the millennium. However, this treatise will not elaborate on the Telemedicine / Tele-health aspects of Digital Health. Some of the aspects of telemedicine are mentioned in the MoHFW web site.
The Clinical Establishment Act (2010) has also kept provisions for eHealth. However, health being a State subject in India, many states are yet to adopt and implement the Act.
The Ministry of Electronics and Information Technology (MeITy), Government of India, is pushing the Digital India initiatives, which include – tele-consultation, online pharmacy, and, pan-India health information exchange. The MeITy and the MoHFW have been jointly involved in developing the Integrated Health Information Platform (IHIP).
In a related happening, the Gazette-notified Medical Devices Act 2017 included Software as a Medical Device (SaMD) within its ambit.
Meanwhile, the Bureau of Indian Standards (BIS) has also created a Sectional Committee for Health Informatics (MHD-17). This Committee has been collaborating with the ISO TC 215 (Health Informatics) to adopt relevant ISO Standards for Indian context.

The Adoption of the Digital Health Resolution
The Digital Health Resolution, adopted in the 71st World Health Assembly, held in Geneva in May 2018, paves the path for WHO to establish a global strategy on digital health. The resolution identifies priority areas including those where WHO should focus its efforts and engage member states to optimize their health systems in harmony with the global digital health agenda. The resolution is the first step towards mainstreaming digital interventions in health including big data and its analytics, use of deep machine learning, artificial intelligence, Internet of things (IoT) and other emerging disciplines like genomics.

Conclusions:
While the NHP-2017 is bold in its thoughts and foresight, for facilitating digital health, the ground realities need to be considered in greater details. Early setting up of a functional NDHA is essential for India to avoid a digital health mess in future. Inordinate delays might make us deal with non-interoperable legacy systems. The first job for the proposed NDHA will be to formulate a robust National Digital Health Strategy / Policy, in consultation with all the stakeholders. Caution needs to be exercised before cross referrals and sharing disparate information among different systems of medicine. Health informatics education must be embedded as an integral part for all health professional education, including health and hospital management. As an initiator of the Digital Health Resolution in the 71st World Health Assembly, India is now well poised to usher in Digital Health smoothly.

References:
Department of Information Technology, Ministry of Communications and Information Technology, Government of India, Information Technology Infrastructure for Health (ITIH), 2003.
National Knowledge Commission: Report to the Nation (21006-2009), https://www.aicte-india.org/downloads/nkc.pdf (Accessed 9th June 2018)
National Health Portal, Ministry of Health and Family Welfare, Government of India, EHR Standards: https://www.nhp.gov.in/ehr-standards-helpdesk_ms (Accessed 9th June 2018)
Sarbadhikari SN, National Health Portal and Centre for Health Informatics, Ch. 4, In, Ganapathy K, Ed, Healthcare Information Technology – The Indian Scenario, NDRF, Bengaluru, 2017: 57 – 67. 
Ministry of Health and Family Welfare, Government of India, Model Curriculum Handbook – Health Information Management, 2015-16:  http://mohfw.nic.in/sites/default/files/Model_Curriculum_Handbook_Health.pdf (Accessed 9th June 2018)
Ministry of Health and Family Welfare, Government of India, National Level Stakeholder Consultation for the proposed National eHealth Authority,  https://www.nhp.gov.in/national-consultation-on-national-ehealth-authority-(neha)_ms 
Ministry of Health and Family Welfare, Government of India, National Health Policy 2017: https://www.nhp.gov.in//NHPfiles/national_health_policy_2017.pdf (Accessed 9th June 2018)
Ministry of Health and Family Welfare, Government of India, Draft of Digital Information Security in Healthcare Act (DISHA) )    https://www.nhp.gov.in/NHPfiles/R_4179_1521627488625_0.pdf (Accessed 9th June 2018)
World Health Assembly, Digital Health Resolution (2018): http://apps.who.int/gb/ebwha/pdf_files/WHA71/A71_ACONF1-en.pdf (Accessed 9th June 2018)
Ministry of Health and Family Welfare, Government of India, Telemedicine and Digital Health: https://mohfw.gov.in/about-us/departments/departments-health-and-family-welfare/e-Health%20%26%20Telemedicine (Accessed 9th June 2018)
Ministry of Electronics and Information Technology (MeITy), Government of India, Digital India initiatives: http://www.digitalindia.gov.in/di-initiatives (Accessed 9th June 2018)
Bureau of Indian Standards (BIS), Ministry of Corporate Affairs, Government of India, Health Informatics Sectional Committee, MHD-17: http://www.bis.org.in/sf/mhd/MHD17(12420)_23022018.pdf (Accessed 9th June 2018)
Government of India, The Gazette of India, dated 31/01/2017: http://www.cdsco.nic.in/writereaddata/Medical%20Device%20Rule%20gsr78E(1).pdf (Accessed 9th June 2018)
Government of India, The Gazette of India, dated 19/8/2010, Clinical Establishments (Registration and Regulation) Act 2010:  http://clinicalestablishments.nic.in/WriteReadData/969.pdf  (Accessed 9th June 2018)
Government of India, The Gazette of India, dated 23/5/2012, Clinical Establishments (Registration and Regulation) Act, (Amendments) 2012:   http://clinicalestablishments.nic.in/WriteReadData/386.pdf (Accessed 9th June 2018)

Wednesday, March 28, 2018

How can Digital Health be Implemented as envisaged in the National Health Policy 2017?

The National Health Policy 2017 (NHP-2017) of India correctly identified the need for creating many new institutions like the National Digital Health Authority (NDHA).  However, the ground realities don’t appear to have been considered well enough. Early setting up of a functional NDHA is essential for India to avoid a digital health mess in future. The first job for the proposed NDHA will be to formulate a robust National Digital Health Strategy / Policy, in consultation with all the stakeholders. Caution needs to be exercised before cross referrals and sharing disparate information among different systems of medicine. Health informatics education must be embedded as an integral part for health and hospital management. It may be prudent to include Health in the Concurrent list of the Constitution of India. That will ensure a smooth adoption of digital health in India. Seeking comments on the Draft Bill DISHA (Digital Information Security in Healthcare Act) is a good start.

It has been now more than a year that the (third edition of the) National Health Policy 2017 (NHP-2017) of India has been notified. While the accompanying Situation Analysis didn’t mention anything about Digital Health, the Policy correctly identified the need for creating many new institutions like the National Digital Health Authority (NDHA).

Now, let us look at where do we stand one year later, regarding the ushering in of Digital Health in India.

First let us glance at some of the key provisions of the NHP-2017 as mentioned in the various sections. Just beneath the quotes from the relevant sections of the NHP-2017, I’m commenting on certain issues for thought.

2.4.3.3 Health Management Information
a. Ensure district-level electronic database of information on health system components by 2020.
b. Strengthen the health surveillance system and establish registries for diseases of public health importance by 2020.
c. Establish federated integrated health information architecture, Health Information Exchanges and National Health Information Network by 2025.

Comments: The NHP-2017 focuses on Digital technology, right from the beginning. Some timelines are also proposed here. However, while some states have been doing very well, some others are lagging. We would further elaborate on this aspect towards the end.

3.3 Organization of Public Health Care Delivery: For effectively handling medical disasters and health security, the policy recommends that the public healthcare system retain a certain excess capacity in terms of health infrastructure, human resources, and technology which can be mobilized in times of crisis.
In order to leverage the pluralistic health care legacy, the policy recommends mainstreaming the different health systems. This would involve increasing the validation, evidence and research of the different health care systems as a part of the common pool of knowledge. It would also involve providing access and informed choice to the patients, providing an enabling environment for practice of different systems of medicine, an enabling regulatory framework and encouraging cross referrals across these systems.
Comments: Here there is a need for more caution since the other streams of medicine – viz., Ayurveda, Yoga and Naturopathy, Siddha, Unani and Homeopathy, follow entirely different principles from those followed by modern medicine. Therefore, cross referrals may add to the complexity and confusion, ultimately harming the patient.

11.1 Medical Education: The policy recognizes the need to revise the under graduate and post graduate medical curriculum keeping in view the changing needs, technology and the newer emerging disease trends.
Comments: There have been a lot of issues regarding the Medical Council of India and the National Board of Examinations in the past, followed by a proposed revamping through the National Medical Commission. Despite all the proposed changes, one of the essential features that is amiss is the incorporation of health informatics essentials in all branches of health professional education. Without doing that, a smooth adoption of digital health is extremely difficult.

11.8 Public Health Management Cadre: The policy proposes creation of Public Health Management Cadre in all States based on public health or related disciplines, as an entry criteria.
Comments: In continuation of the previous section, health information management must be embedded as an integral part for health and hospital management. Health Informatics weds both health information technology and health information management. Scaling up, public health informatics combines health informatics and population demographics.

13.12: Health Information System: The objective of an integrated health information system necessitates private sector participation in developing and linking systems into a common network/grid which can be accessed by both public and private healthcare providers. Collaboration with private sector consistent with Meta Data and Data Standards and Electronic Health Records would lead to developing a seamless health information system. The private sector could help in creation of registries of patients and in documenting diseases and health events.
Comments: Most of the times various health information systems don’t talk to each other and therefore there is a dire need of Standards for interoperability. I would discuss this issue in greater details this issue towards the end, where I would talk about the Clinical Establishments Act.

14.2: Regulation of Clinical Establishments: A few States have adopted the Clinical Establishments Act 2010. Advocacy with the other States would be made for adoption of the Act. Grading of clinical establishments and active promotion and adoption of standard treatment guidelines would be one starting point. Protection of patient rights in clinical establishments (such as rights to information, access to medical records and reports, informed consent, second opinion, confidentiality and privacy) as key process standards, would be an important step. Policy recommends the setting up of a separate, empowered medical tribunal for speedy resolution to address disputes /complaints regarding standards of care, prices of services, negligence and unfair practices. Standard Regulatory framework for laboratories and imaging centers, specialized emerging services such as assisted reproductive techniques, surrogacy, stem cell banking, organ and tissue transplantation and Nano Medicine will be created as appropriate.
Comments: Discussed below separately.

14.5: Medical Devices Regulation: The policy recommends strengthening regulation of medical devices and establishing a regulatory body for medical devices to unleash innovation and the entrepreneurial spirit for manufacture of medical device in India. The policy supports harmonization of domestic regulatory standards with international standards. Building capacities in line with international practices in our regulatory personnel and institutions, would have the highest priority. Post market surveillance program for drugs, blood products and medical devices shall be strengthened to ensure high degree of reliability and to prevent adverse outcomes due to low quality and/or refurbished devices/health products.
Comments:  Medical Devices Rules, 2017 that has come into force with effect from 1st day of January, 2018, has included in the Part-I of the first schedule Parameters for classification of medical devices other than in vitro diagnostic medical devices. There, Software as Medical Device (SaMD) is defined as: (iii) Software, which drives a device or influences the use of a device, falls automatically in the same class. This is indeed a very forward looking and welcome legislation, ahead of the times in our country.

22: Health Technology Assessment: Health Technology assessment is required to ensure that technology choice is participatory and is guided by considerations of scientific evidence, safety, consideration on cost effectiveness and social values. The National Health Policy commits to the development of institutional framework and capacity for Health Technology Assessment and adoption.
Comments: We can combine these aspects with the digital health technology, described in the next section.

23: Digital Health Technology Eco - System: Recognising the integral role of technology(eHealth, mHealth, Cloud, Internet of things, wearables, etc) in the healthcare delivery, a National Digital Health Authority (NDHA) will be set up to regulate, develop and deploy digital health across the continuum of care. The policy advocates extensive deployment of digital tools for improving the efficiency and outcome of the healthcare system. The policy aims at an integrated health information system which serves the needs of all stake-holders and improves efficiency, transparency, and citizen experience. Delivery of better health outcomes in terms of access, quality, affordability, lowering of disease burden and efficient monitoring of health entitlements to citizens, is the goal. Establishing federated national health information architecture, to roll-out and link systems across public and private health providers at State and national levels consistent with Metadata and Data Standards (MDDS) & Electronic Health Record (EHR), will be supported by this policy. The policy suggests exploring the use of “Aadhaar” (Unique ID) for identification. Creation of registries (i.e. patients, provider, service, diseases, document and event) for enhanced public health/big data analytics, creation of health information exchange platform and national health information network, use of National Optical Fibre Network, use of smartphones/tablets for capturing real time data, are key strategies of the National Health Information Architecture.

23.1 Application of Digital Health: The policy advocates scaling of various initiatives in the area of tele-consultation which will entail linking tertiary care institutions (medical colleges) to District and Sub-district hospitals which provide secondary care facilities, for the purpose of specialist consultations. The policy will promote utilization of National Knowledge Network for Tele-education, Tele-CME, Tele-consultations and access to digital library.
23.2 Leveraging Digital Tools for AYUSH: Digital tools would be used for generation and sharing of information about AYUSH services and AYUSH practitioners, for traditional community level healthcare providers and for household level preventive, promotive and curative practices.

Comments: This is a very correct decision and the first job for the proposed NDHA will be to formulate a robust National Digital Health Strategy / Policy, in consultation with all the stakeholders. The first constituents of the Authority will lay down the rules of the game as to how will digital health be adopted in India. The earlier the NDHA is set up and functional, the better it will be for India to avoid a digital health mess in future. Any delay in the process might make us deal with non-interoperable legacy systems, as has been the case in many developed nations. However, cross referrals and sharing disparate information among different systems of medicine may add to the complexity and confusion, ultimately harming the patient. Currently, the MoHFW is seeking comments on the proposed DISHA (Digital Information Security in Healthcare Act) that will be the Bill setting up the NDHA / NeHA.

25. Health Research: The National Health Policy recognizes the key role that health research plays in the development of a nation’s health. In knowledge based sector like health, where advances happen daily, it is important to increase investment in health research.

25.1 Strengthening Knowledge for Health: The policy envisages strengthening the publicly funded health research institutes under the Department of Health Research, the apex public health institutions under the Department of Health & Family Welfare, as well as those in the Government and private medical colleges. The policy supports strengthening health research in India in the following fronts- health systems and services research, medical product innovation (including point of care diagnostics and related technologies and internet of things) and fundamental research in all areas relevant to health- such as Physiology, Biochemistry, Pharmacology, Microbiology, Pathology, Molecular Sciences and Cell Sciences. Policy aims to promote innovation, discovery and translational research on drugs in AUSH and allocate adequate funds towards it. Research on social determinants of health along with neglected health issues such as disability and transgender health will be promoted. For drug and devices discovery and innovation, both from Allopathy and traditional medicines systems would be supported. Creation of a Common Sector Innovation Council for the Health Ministry that brings together various regulatory bodies for drug research, the Department of Pharmaceuticals, the Department of Biotechnology, the Department of Industrial Policy and Promotion, the Department of Science and Technology, etc. would be desirable. Innovative strategies of public financing and careful leveraging of public procurement can help generate the sort of innovations that are required for Indian public health priorities. Drug research on critical diseases such as TB, HIV/AIDS, and Malaria may be incentivized, to address them on priority. For making full use of all research capacity in the nation, grant- in- aid mechanisms which provide extramural funding to research efforts is envisaged to be scaled up.

25.2 Drug Innovation & Discovery: Government policy would be to both stimulate innovation and new drug discovery as required, to meet health needs as well as ensure that new drugs discovered and brought into the market are affordable to those who need them most. Similar policies are required for discovering more affordable, more frugal and appropriate point of care diagnostics as also robust medical equipment for use in our rural and remote areas. Public procurement policies and public investment in priority research areas with greater coordination and convergence between drug research institutions, drug manufacturers and premier medical institutions must also be aligned to drug discovery.

25.3 Development of Information Databases: There is also a need to develop information data-bases on a wide variety of areas that researchers can share. This includes ensuring that all unit data of major publicly funded surveys related to health, are available in public domain in a research friendly format.

25.4 Research Collaboration: The policy on international health and health diplomacy should leverage India’s strength in cost effective innovations in the areas of pharmaceuticals, medical devices, health care delivery and information technology. Additionally leveraging international cooperation, especially involving nations of the Global South, to build domestic institutional capacity in green-field innovation and for knowledge and skill generation could be explored.
Comments: For health research and innovation the government’s role of encouraging Standards for interoperability and allowing open data for analysis will go a long way.
Apart from the NHP-2017, there are certain existing legislations that affects the adoption of digital health in India. The first and foremost is the 2012 Amendments of the Clinical Establishments Act 2010. The other guidance comes from the Constitution of India. Both of these are discussed below.

Clinical Establishments (Registration and Regulation) Act (CEA): In 2012, the MoHFW amended the CEA (2010) and added Clause “9 (iv): the clinical establishments shall maintain and provide Electronic Medical Records (EMR) or Electronic Health Records (EHR) of every patient as may be determined and issued by the Central Government or the State Government as the case may be, from time to time”.
Comments: The Act has taken effect in the four states namely, Arunachal Pradesh, Himachal Pradesh, Mizoram, Sikkim, and all Union Territories since 1st March, 2012 vide Gazette notification dated 28th February, 2012. The states of Uttar Pradesh, Uttarakhand, Rajasthan, Jharkhand, Bihar and Assam have adopted the Act under clause (1) of article 252 of the Constitution. 
The Ministry has notified the National Council for Clinical Establishments and the Clinical Establishments (Central Government) Rules, 2012 under this Act vide Gazette notifications dated 19th March, 2012 and 23rd May, 2012 respectively.

The Act is applicable to all kinds of clinical establishments from the public and private sectors, of all recognized systems of medicine including single doctor clinics. The only exception will be establishments run by the Armed forces.

The good point is the enactment of the necessity for EMR / EHR. The Ministry of Health and Family Welfare has been notifying Standards for EHR since August 2013 and the second edition of the Guidelines were notified in December 2016. That is the right way to move forward. However, Health being a State subject, not all the states are equally keen to adopt it.

Concurrent List: The seventh schedule of the Constitution of India lists “Health” (Public health and sanitation; hospitals and dispensaries) under the Item 6 of List-II (State list). As expected, like the Union ministry, health ministers of various states have also agreed to equipping PHCs and CHCs with latest technology.
Comments: However, as seen in the previous section, the CEA has not yet been adopted by most of the states of India. Therefore, although the CEA mandates EMR / EHR, most of the states are not yet bound to follow it. Since Health is neither in the Union list, nor in the Concurrent list, it may be prudent to include it in the Concurrent list. In that case adoption of digital health would be much smoother.

Conclusions:
While the NHP-2017 is bold in its thoughts and foresight, for facilitating digital health, the ground realities don’t appear to have been considered well enough. Early setting up of a functional NDHA is essential for India to avoid a digital health mess in future. Inordinate delays might make us deal with non-interoperable legacy systems. The first job for the proposed NDHA will be to formulate a robust National Digital Health Strategy / Policy, in consultation with all the stakeholders. Caution needs to be exercised before cross referrals and sharing disparate information among different systems of medicine. Health informatics education must be embedded as an integral part for health and hospital management. Since Health is neither in the Union list, nor in the Concurrent list of the Constitution of India, it may be prudent to include it in the Concurrent list. In that case adoption of digital health would be much smoother. Seeking comments on the Draft Bill DISHA (Digital Information Security in Healthcare Act) is a good start.


References:
  1. Ministry of Health and Family Welfare, Government of India, National Health Policy 2017: https://www.nhp.gov.in//NHPfiles/national_health_policy_2017.pdf (Accessed 19th February 2018)
  2. Ministry of Health and Family Welfare, Government of India. Situation Analyses: Backdrop to the National Health Policy – 2017, New Delhi. Available from : https://mohfw.gov.in/sites/default/files/71275472221489753307.pdf
  3. Sundararaman T, National Health Policy 2017: A Cautions Welcome, Indian J Med Ethics. 2017 Apr-Jun;2(2):69-71
  4. Sarbadhikari SN. A farce called the National Board of Examinations. Indian J Med Ethics. 2010 Jan-Mar;7(1):20-2
  5. Thomas G, Medical education in India – the way forward, Indian J Med Ethics. 2016 Oct-Dec;1(4):200
  6.  Government of India, The Gazette of India, dated 31/01/2017: http://www.cdsco.nic.in/writereaddata/Medical%20Device%20Rule%20gsr78E(1).pdf (Accessed 19th February 2018)
  7. Government of India, The Gazette of India, dated 19/8/2010, Clinical Establishments (Registration and Regulation) Act 2010:  http://clinicalestablishments.nic.in/WriteReadData/969.pdf  (Accessed 19th February 2018)
  8. Government of India, The Gazette of India, dated 23/5/2012, Clinical Establishments (Registration and Regulation) Act, (Amendments) 2012:   http://clinicalestablishments.nic.in/WriteReadData/386.pdf (Accessed 19th February 2018)
  9. Ministry of Health and Family Welfare, Government of India.  http://clinicalestablishmentstraining.nic.in/cms/Home.aspx (Accessed 19th February 2018)
  10. National Health Portal, Ministry of Health and Family Welfare, Government of India, EHR Standards: https://www.nhp.gov.in/electronic-health-record-standards-for-india-helpdesk_mty (Accessed 19th February 2018)
  11. Government of India, The Constitution of India  http://lawmin.nic.in/olwing/coi/coi-english/coi-4March2016.pdf  (Accessed 19th February 2018)
  12. Press Information Bureau, Government of India, Shri J P Nadda chairs 12th Conference of the Central Council of Health and Family Welfare to discuss Draft National Health Policy, dated 27/02/2016: http://pib.nic.in/newsite/PrintRelease.aspx?relid=136961 (Accessed 19th February 2018)
  13. Ministry of Health and Family Welfare, Government of India. https://mohfw.gov.in/newshighlights/comments-draft-digital-information-security-health-care-actdisha (Accessed 28th March 2018)
  14. National Health Portal, Ministry of Health and Family Welfare, Government of India, EHR Standards: https://www.nhp.gov.in/ehr-standards-helpdesk_ms (Accessed 28th March 2018)

Thursday, January 11, 2018

The Role of Change Management and Capacity Building for the smooth adoption of Digital Health in India

Digital health electronically connects the points of care so that health information can be shared securely to help deliver safer, better quality healthcare.
The broad scope of Digital Health includes categories such as mobile health (mHealth), health information technology (IT), wearable devices, telehealth and telemedicine, and personalized medicine. Digital health is about electronically connecting the points of care so that health information can be shared securely. This is the first step to understanding how digital health can help deliver safer, better quality healthcare.
Health Information Management (HIM) professionals are well trained in the latest information management technology applications and understand the workflow in any health care provider organization. Health Information Managers are vital to the daily operations management of health information and electronic health records (EHRs). They ensure that Data Quality is maintained, by applying the principles of Change Management and continuous capacity building through education and training. They ensure that the health information and records of a patient are complete, accurate, protected and meet the desired and stipulated medical, legal and ethical standards. Therefore, it must be made mandatory to appoint an adequate number of health information managers, according to the size of the healthcare organization, to ensure safe and smooth adoption of digital health in India, leading to informed healthcare delivery.
These professionals affect the quality of patient information and patient care at every point in the health care delivery cycle. They work on the classification of diseases and treatments to ensure they are standardized for clinical, financial, and legal uses in health care. HIM professionals care for patients by caring for their medical data. This, in turn, leads to informed healthcare delivery, especially when and where the information is translated into actionable outputs.
I have been tracing the evolution of health informatics and health information managers in making healthcare delivery more informed. Further they also show the role of unlearning and relearning in effectively assimilating information for better healthcare delivery.
As the Indian government aims for Universal Health Coverage (UHC), the lack of skilled human resource may prove to be the biggest impediment in its path to achieve targeted goals. Therefore, the model curriculum handbook on health information management has been designed with a focus on performance-based outcomes pertaining to different levels. The learning goals and objectives of the undergraduate and graduate education program are based on the performance expectations. These are articulated as learning goals and learning objectives. Using this framework, students will learn to integrate their knowledge, skills and abilities in a hands-on manner in a professional healthcare setting. These learning goals are divided into nine key areas, though the degree of required involvement may differ across various levels of qualification and professional cadres:

1. Clinical care
2. Communication
3. Membership of a multidisciplinary health team
4. Ethics and accountability at all levels (clinical, professional, personal and social)
5. Commitment to professional excellence
6. Leadership and mentorship
7. Social accountability and responsibility
8. Scientific attitude and scholarship (only at higher level- PhD)
9. Lifelong learning

Among these nine core competencies, the third one (Membership of a multidisciplinary health team) is perhaps the most important. The student will learn to put a high value on effective communication within the team, including transparency about aims, decisions, uncertainty and mistakes. Team-based health care is the provision of health services to individuals, families, and/or their communities by at least two health providers who work collaboratively to accomplish shared goals within and across settings to achieve coordinated, high quality care. Program objectives will aim at making the students being able to:
Ø  Recognize, clearly articulate, understand and support shared goals in the team that reflect patient and family priorities
Ø  Possess distinct roles within the team; to have clear expectations for each member’s functions, responsibilities, and accountabilities, which in turn optimizes the team’s efficiency and makes it possible for them to use division of labor advantageously, and accomplish more than the sum of its parts
Ø  Develop mutual trust within the team to create strong norms of reciprocity and greater opportunities for shared achievement
Ø  Communicate effectively so that the team prioritizes and continuously refines its communication channels creating an environment of general and specific understanding
Ø  Recognize measurable processes and outcomes, so that the individual and team can agree on and implement reliable and timely feedback on successes and failures in both the team’s functioning and the achievement of their goals. These can then be used to track and improve performance immediately and over time.

As this model curriculum is competency-based, it connects the dots between the ‘know what’ and ‘do how’ for HIM professionals.
The National Health Policy-2017 advocates extensive deployment of digital tools for improving the efficiency and outcome of the healthcare system. The policy aims at an integrated health information platform or system which serves the needs of all stake-holders and improves efficiency, transparency, and citizen experience. Delivery of better health outcomes in terms of access, quality, affordability, lowering of disease burden and efficient monitoring of health entitlements to citizens, is the goal. Establishing federated national health information architecture, to roll-out and link systems across public and private health providers at State and national levels consistent with Metadata and Data Standards (MDDS) and Electronic Health Record (EHR) Standards, will be supported by this policy. The policy suggests exploring the use of “Aadhaar” (Unique ID or UID) for identification. Creation of registries (i.e. patients, provider, service, diseases, document and event) for enhanced public health/big data analytics, creation of health information exchange platform and national health information network, use of National Optical Fiber Network (NOFN), use of smart phones/tablets for capturing real time data, are key strategies of the National Health Information Architecture. The policy advocates scaling of various initiatives in the area of tele-consultation which will entail linking tertiary care institutions (medical colleges) to District and Sub-district hospitals which provide secondary care facilities, for the purpose of specialist consultations. The policy will promote utilization of National Knowledge Network (NKN) for Tele-education, Tele-CME, Tele-consultations and access to digital library.
The National Health Policy 2017 of India states that recognizing the integral role of technology (eHealth, mHealth, Cloud, Internet of Things or IoT, wearables) in the healthcare delivery, a National Digital Health Authority (NDHA) will be set up to regulate, develop and deploy digital health across the continuum of care.
Currently, in the International Institute of Health Management Research, New Delhi,  I am involved in training such professionals through a regular 2-year PGDHM (Post Graduate Diploma in Health and Hospital Management) course that is equivalent to MBA, as per the Association of Indian Universities (AIU), and also through short-term Management Development Programs (MDP) for in-service professionals.
To conclude, HIM professionals are very well trained and suited to ensure that the health information and records (EHRs) of a patient are complete, accurate, protected and meet the desired and stipulated medical, legal and ethical standards. Therefore, it must be made mandatory to appoint an adequate number of health information managers, according to the size of the healthcare organization, to ensure safe and smooth adoption of digital health in India, leading to informed and safer healthcare delivery.