Riding the Digital Health Wave: The Investment Whisperer

A HealthTech Investment Banking Odyssey: Bridging the Gap Between Investments and Innovation.

The year was 2011, and the world of healthcare was on the cusp of a revolution. Bengaluru, India, was buzzing with the energy of startups looking to leverage technology to transform patient care. This is where I found myself as a newly minted RoI Consultant, after 15 years of corporate jobs and an Executive MBA from IIMB, stepping into the exciting world of Angel and VC funds.

My first foray was with Norwest Venture Partners, a prestigious VC firm. Here, I donned the hat of an eHealth consultant, tasked with evaluating promising Healthtech startups. It was a thrilling dance – dissecting business models, assessing market potential, and ultimately, helping shape the investment portfolio e.g. Attune, Nationwide Clinics, Bluecap etc. But my role wasn't merely financial. I became an advisor for mHealth product design, drawing on my understanding of user needs and technological possibilities to guide the development process. For example - When we first met Attune, it was a small 20-member HealthTech startup in Chennai, we worked with them as they got funded and went on to become a multi-million dollar MNC.

Then was hired by one of India’s top 3 IT services companies to help consolidate their wild spread of HealthTech product investments. True to my habit, I spoke my global mind and the advice didn’t go down well with the Indian IT services Leaders. I and my team silently stepped aside from the project. Subsequently our worst fears came true - The IT services company lost all their investment in the HealthTech product portfolio and their Healthcare product unit was shut down.

The experience proved invaluable. Equipped with this knowledge, I transitioned to RoI Consulting for Seiler Holding AG, Zurich, Switzerland. This time, I wasn't just advising, I was leading the charge. As the CMIO for Promed, a Healthtech startup, I took on the mantle of full-fledged Product Owner. It was an exhilarating rollercoaster – from crafting the product vision to meticulously overseeing every stage of development, from design to launch. The product got developed but the investors decided to take it to Europe instead of launching it in India because they found the product way ahead of the curve for the India market.

Years passed, and my expertise continued to evolve. In 3737 North Capital, I became a Venture Partner for HealthTech, BioTech, Wellness, and FoodTech. Here, I wasn't just evaluating startups, I was actively shaping their destinies. As a Board Observer for Medimetry, a HealthTech startup, I revisited my product management roots, strategizing, monitoring, and ensuring a flawless product journey. Medimetry went through its own tumbles, turns and pivots but has survived to tell its own story.

One of the founders of 3737N moved into BlueSky Capital and pulled me into it along with him. All the HealthTech and MedTech startups I recommended to BlueSky were rejected by the BlueSky investment board because they couldn't see HealthTech potential from their 3x/3 lens. However many of these startups went on to become Series D funded and beyond.

Meanwhile I was invited to Saudi Arabia to help a leading chain of Hospitals to save the bleeding cash in their new hospital’s constructions and hospital expansion programs. Based on our recommendations, the client restructured some of their building construction contracts and saved $27M. We were paid our full fees, and the bonus was strong client recommendations.

But my passion extended beyond individual companies. I saw the potential for a collective impact. This led me to develop and manage a Social Entrepreneurship Accelerator (SEA) in collaboration with the Market Access Program, NHA, Government of India. Here, I nurtured a vibrant ecosystem of 40 HealthTech, Medtech, and Insurtech startups, fostering innovation and social good. Many of these companies went on to become front-runners and early-adopters of ABDM standards in India. The SEA program was shut down because the funding ran dry during the pandemic.

My journey hasn't been confined to for-profit ventures. Recognizing the importance of collaboration, I served as a Jury Member for various BIRAC funded government initiatives aimed at propelling healthcare innovation forward. Additionally, I actively fostered knowledge exchange through initiatives like the Libra Social Academy and Libra Social Innovation, partnering with esteemed institutions like IIT Jodhpur.

Looking back, it's been a remarkable adventure. From the boardrooms of VC firms to the heart of social innovation, I've witnessed the transformative power of technology in healthcare. It's a story not just about financial returns, but about the potential to touch lives and improve well-being on a grand scale. And this story, this journey, is far from over. The future of HealthTech beckons, and I, the investment whisperer, am ready to lend an ear and guide the way.

Here is what I learnt: For the investment with 3 years time horizon, HealthTech looses out to traditional sectors like FMCG, BFSI, Retail, Manufacturing etc. However HealthTech wins hands-down when the fund can absorb a gestation period of 7-9 years. Whenever impatient, please remind yourself that the gestation period of human is 9 months but for a mammoth it is 18 months.

India's Digital Health Journey

I (Dr Pankaj Gupta) have been an integral part of India's Digital Health Journey. Here is a summary of my work over the last 15 years. Someday probably I will write a book with all the stories and anecdotes. I am not a public health person, I came in through the back-door but can't believe I have stuck to it.

I started my digital health journey in India's public health arena in 2011. The work I had done for Max Healthcare's complete digital health transformation caught the eye of Government of India in Aug 2010 when I was featured on the cover page of the eHealth magazine. Later Max healthcare became the only Hospital chain in India to be integrated seamlessly across all 12 hospitals hosted on the Dell private cloud and it achieved HIMSS stage 6 accreditation.

Somehow I got talking to Dr Sundararaman T ED @ NHSRC. He invited me to start writing the Public Health IT study report together with NHSRC. This report looked at various public health IT systems built by various vertical programs and found out that every system was built at different points in time in different technologies without any interoperability. There is no way you can analyze the data across vertical programs even if you wanted to triangulate. My favorite example is a low birth weight baby born to a woman who had tuberculosis in the past; then there is no way to trace it back because infants data, birth data, pregnancy data, and TB data are in different systems that don't talk to each other.

In the public health IT study report, I borrowed a lot from my experiences of having done digital health standards consulting work in USA, Canada and couple of other countries. The public health IT study report gave the recommendation that India's ministry of health and ministry of IT needs to get together and write the Healthcare-IT or eHealth standards. So that the various vertical programs can talk to each other and the data can be auto triangulated on near-real-time basis without human interventions. The then planning commission took note of it and included the recommendation in the 12th plan. The institutional memory of this public health IT study report was lost. It turned out to be a beautiful book sitting on the shelf with no users.

Somewhere in 2013 the Government of India setup 2 committees - EHR Standards committee and MDDS for Health Standards committee. I had the fortune of leading the taskforce that wrote the MDDS for Health and I was a consultant to the EHR Standards committee. The MDDS for Health draft standards were published in 2013-2014. It turned out to be a beautiful book sitting on the shelf with no users.

Meanwhile in 2015, MoHFW gave me a project to create India's first Health Facility Registry with a unique national ID number [NIN_HFI]. My team pulled out 250k health facility data from MCTS and HMIS systems to come up with a curated list of 112k health facilities. It again turned out to be a beautiful book sitting on the shelf with no users. Meanwhile the institutional memory was lost.

It took 5 years for the MDDS for Health to be notified by STQC Ministry of IT in Aug 2018. In the meanwhile EHR Standards were also notified by Ministry of Health. EHR standards gave the what and the why of digital health and MDDS for health gave the how part of Digital Health. This was recognized as a digital necessity for starting the Ayushman Bharat in Sep 2018. Also in 2018 it was decided to write the Digital Health blueprint to serve as the Reference Architecture.

In Nov 2018 I was called to discuss an international donors funded project called Digital for Universal Health Coverage in India. Starting Jan 2019, I led transformative initiatives thru the digital health division of a public health NPO, a division I created for advancing digital solutions for Universal Health Coverage (UHC).

Key achievements from a $3M Digital for UHC Grant were - inputs to the writing of NDHB Digital Health Standards, that defined crucial digital health standards for the National Digital Health Blueprint (NDHB). Building the (#ABDM) Digital Health Authority Consensus; i.e. Orchestrated the campaign for consensus-building among public-private-academic sectors for the #ABDM Authority. Digital Health Adoption Framework; Crafted a framework to strengthen digital health adoption, setting the stage for the National Digital Health NDHE Ecosystem.

Thought Leadership: Co-authored Chapter 5 of "Health Systems for New India: Wiring the Indian Health Sector" with Niti Aayog. Advocated for policy changes and recommended Interoperability eObjects. The Chapter 5 of the book gave the 6-pillar strategy spanning Governance, Health Data Standards, Delivery Information Systems, Insurance Platforms, Health Information Exchanges, and IT Infrastructure. That formed the basis for establishing a Strategy Council for guided health system transformation. Led the Program Management Unit, overseeing grant, project, and operations management. Conducted stakeholder consultations for informed policy decisions.

We were hit by the Pandemic in 2020 and everything shifted to work from home. Government fast-tracked the creation of the National Digital Health Mission and Hon' PM announced it on 15th Aug 2020 from the Red Fort. Later it was upgraded to PM' Ayushman Bharat Digital Mission ABDM in Sep 2021. So I cant take all of the credit for this work - because Covid did the magic.

Healthcare is a State subject, whereas IT is a Central subject. Therefore a well considered recommendation was to institutionalize the digital health authority as a mission mode project under Digital India, and house it in the National Health Authority.

Market Access Program was started by NHA to help build the Digital Health Ecosystem. I led the Social Entrepreneurship Accelerator (SEA) associated with the MAP, fostering partnerships within the healthcare innovation ecosystem.

Health Insurance claims engine was envisaged as a innovative solution for digital health adoption. From my past experience, I can vouch for it - Globally Health Insurance and Financial Levers has been the drivers of Digital Health adoption. Therefore I contributed to Health Claims Exchange (HCX) specifications, enabling eClaims automation in NHA/ABPMJAY and InsurTech.

Founded Digital Health Academy, nurturing institutions for HealthTech and Epidemiology capacity building. Established Opensource Software Community, creating a Digital Health Centre of Excellence (CoE). Coordinated opensource partnerships with international organizations, universities and education institutes. This is because I knew that the biggest stumbling block for Digital Health implementation will be the lack of digital health HR capacity in the system. This is because in the Indian education system - after class X the biology and mathematics streams separate and never meet again. Whereas we need exactly that biology plus mathematics combination in the same brain for digital health implementation and roll-out across the states.

The opensource HMIS MVP design created could not be converted into a working software because the donors didn't consent for the money to be used for software development. Arun Kumbhat, Dr Ramachandran Balaji and me didn't give up even after the grant came to an end; we started LIBRA SOCIAL RESEARCH FOUNDATION a section-8 company and rewrote the HMIS MVP specifications. LetsDoc stepped forward to convert the specifications into low level design and then write up the software code. LetsDoc stood to their promise and released the HMIS MVP into opensource. Thus was born the OpenHDIS project and the community. LetsDoc and IIT Jodhpur are the first member organizations to join the OpenHDIS community.

Digital Health Standards done! Digital Health Policy done! Digital Health Authority done! My next chapter will be Digital Health Implementation...

Regulatory Pathways for Medical Software

Why India needs to regulate medical software

Medical software is a rapidly evolving field that has the potential to transform healthcare delivery and improve patient outcomes. Medical software can be defined as any software that is intended for medical purposes, such as diagnosis, treatment, prevention, monitoring, or management of diseases or conditions. Examples of medical software include electronic health records, clinical decision support systems, telemedicine platforms, mobile health apps, artificial intelligence tools, and wearable devices.

However, medical software also poses significant challenges and risks for patients, healthcare providers, and regulators. Medical software can have direct or indirect impact on the health and safety of users, and can cause harm if it is not designed, developed, tested, and maintained properly. Some of the potential harms include incorrect diagnosis, inappropriate treatment, data breaches, privacy violations, cyberattacks, and adverse events.

Therefore, it is essential that medical software is regulated by competent authorities to ensure its quality, safety, effectiveness, and reliability. Regulation can also foster innovation and trust in the medical software industry by providing clear and consistent standards and guidelines for developers and users.

How other countries regulate medical software

Several countries have already established regulatory frameworks for medical software, such as the United States (US), the European Union (EU), and Australia. These frameworks are based on the principle of risk-based classification, which means that different levels of regulatory oversight are applied depending on the potential harm that the medical software can cause to users.

For example, in the US, the Food and Drug Administration (FDA) regulates medical software as a type of medical device under the Federal Food, Drug, and Cosmetic Act. The FDA classifies medical software into three classes: Class I (low risk), Class II (moderate risk), and Class III (high risk). The FDA also provides guidance documents and policies to clarify the scope and requirements of regulation for different types of medical software.

Similarly, in the EU, the Medical Device Regulation (MDR) regulates medical software as a type of medical device under the EU law. The MDR classifies medical software into four classes: Class I (low risk), Class IIa (low-medium risk), Class IIb (medium-high risk), and Class III (high risk). The MDR also provides rules and criteria for conformity assessment, clinical evaluation, post-market surveillance, and vigilance for medical software.

In Australia, the Therapeutic Goods Administration (TGA) regulates medical software as a type of medical device under the Therapeutic Goods Act. The TGA classifies medical software into four classes: Class I (low risk), Class IIa (low-medium risk), Class IIb (medium-high risk), and Class III (high risk). The TGA also provides guidance documents and standards to help developers and users understand the regulatory requirements for medical software.

What India can learn from other countries

India is one of the largest and fastest-growing markets for medical software in the world. According to a report by Nasscom, the Indian healthcare IT market is expected to reach $8.5 billion by 2023. However, India does not have a comprehensive and coherent regulatory framework for medical software yet.

Currently, medical software in India is regulated by various authorities under different laws and regulations. For example, some types of medical software are regulated by the Central Drugs Standard Control Organization (CDSCO) under the Drugs and Cosmetics Act; some types of medical software are regulated by the Ministry of Electronics and Information Technology (MeitY) under the Information Technology Act; some types of medical software are regulated by the Ministry of Health and Family Welfare (MoHFW) under the National Digital Health Mission; and some types of medical software are not regulated at all.

This situation creates confusion, inconsistency, ambiguity, and uncertainty for developers and users of medical software in India. It also hampers innovation and adoption of medical software in India by creating barriers to entry, increasing costs and risks, and reducing competitiveness.

Therefore, India needs to learn from other countries and develop a harmonized and streamlined regulatory framework for medical software that is based on the following principles:

• Risk-based classification: Medical software should be classified into different classes based on the potential harm that it can cause to users. The level of regulatory oversight should be proportional to the level of risk.
• Conformity assessment: Medical software should undergo a process of verification and validation to demonstrate its compliance with the applicable standards and regulations. The process should be transparent, efficient, and consistent.
• Clinical evaluation: Medical software should provide evidence of its clinical performance and safety based on scientific data from clinical trials or real-world studies. The evidence should be relevant, reliable, and robust.
• Post-market surveillance: Medical software should be monitored after its deployment to identify any problems or issues that may arise during its use. The problems or issues should be reported, analyzed, and resolved in a timely manner.
• Vigilance: Medical software should have a system of reporting and managing any adverse events or incidents that may occur during its use. The adverse events or incidents should be investigated, mitigated, and prevented from recurring.

How India can implement a regulatory framework for medical software

To implement a regulatory framework for medical software in India, the following steps are recommended:

• Revise the Drugs and Cosmetics Act: The Drugs and Cosmetics Act should be revised to include medical software as a type of medical device and to define its scope and criteria. The CDSCO should be empowered to regulate medical software as a central authority under the Act.
• Align with NDHB and ABDM: The CDSCO should align its regulatory framework with the National Digital Health Blueprint (NDHB) and the Ayushman Bharat Digital Mission (ABDM), which are the national initiatives to create a digital health ecosystem in India. The CDSCO should recognize the NDHB and the ABDM as the digital health standards bodies in India and adopt their specifications and protocols for medical software regulation.
• Collaborate with MeitY and STQC: The CDSCO should collaborate with MeitY and the Standardization Testing and Quality Certification (STQC) Directorate to leverage their expertise and resources in the field of information technology and quality assurance. The CDSCO, ABDM, MeitY, and STQC should work together to develop and implement standards, guidelines, and procedures for medical software regulation.
• Engage with Ecosystem: The CDSCO should engage with various healthcare ecosystem stakeholders, such as software developers, end-users, healthcare providers, payers, pharma, researchers, academia, industry associations, civil society organizations, and international agencies, to solicit their feedback and inputs on the regulatory framework for medical software. The CDSCO should also conduct awareness and education campaigns to inform and educate the stakeholders about the benefits and obligations of medical software regulation.

Conclusion

Medical software is a promising and challenging field that can revolutionize healthcare delivery and improve patient outcomes in India. However, medical software also requires proper regulation to ensure its quality, safety, effectiveness, and reliability. India can learn from other countries that have established regulatory frameworks for medical software based on risk-based classification, conformity assessment, clinical evaluation, post-market surveillance, and vigilance. India can also implement a regulatory framework for medical software by revising the Drugs and Cosmetics Act, collaborating between CDSCO, ABDM, MeitY and STQC, aligning with NDHB Standards, and engaging with healthcare ecosystem. By doing so, India can create a conducive environment for innovation and trust in the medical software industry.

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Here is a summary of the lecture by Dr Pankaj Gupta on the topic Regulatory pathways for medical software:

Dr Gupta begins by discussing the different categories of medical software, including standalone software, software inside a medical device, software associated with a medical device, and software as a medical device.

Dr Gupta then moves on to discuss the risk classification of medical software. They explain that most regulatory bodies treat medical software as a medical device and that medical devices are classified into three classes based on their risk: Class I, Class II, and Class III.

Dr Gupta then discusses the regulatory pathways for medical software in the United States, the European Union, and Canada. They explain that the regulatory pathway for medical software depends on the risk classification of the software.

Dr Gupta concludes by discussing the future of the regulatory framework for medical software. They argue that the regulatory framework needs to be strengthened to keep up with the rapid pace of technological advancement.

Here are some of the key points from the presentation:

• Medical software is a broad category that includes a variety of different types of software.
• Medical software is regulated as a medical device in most countries.
• The risk classification of medical software determines the regulatory pathway that the software must follow.
• The regulatory framework for medical software is evolving to keep up with the rapid pace of technological advancement.

Libra Social Academy

Libra Social Academy brings to you Library of PankajGuptadr Healthcare Management YouTube Channel -- valuable insight into the teachings of Dr Pankaj Gupta and Team, well know HealthTech and Healthcare Management experts. 

All the documents, design, code and content is published in opensource for the larger public good as per MeitY opensource policy and under the MPL 2.0 License.

BWHealth - Bharat Swasth Mahotsav - Padma Awardee Doctors Conclave - 22 Aug 2022
See the first panel discussion on HealthTech.

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Building Unique and Innovative strategies for Healthcare & Life Sciences Sector

Training on Successful Implementation of a Digital Financial Services for Health Project

Message on Universal Health Coverage

Biospectrum India at Healthscape Summit India 2017

Elets Interview- Dr. Pankaj Gupta, at Annual HIS

At Global VC Summit with Dr Pankaj Gupta.

Elets Healthcare Award 2019 : Dr Pankaj Gupta

CII DX Summit 3.0 | Day 1 22 February, Session on  Building Unique and Innovative strategies for Healthcare & Life Sciences Sector - Opportunities & Road Ahead.

Elets Annual HIS 2019

Healthscape IDE 2017 Panel Discussion Video1

Jaipur National University - one day virtual international conference - See 4:51 to 6:45

BRICS CCI: Webinar on 'Exploring Opportunities in the Digital Health Market' - See 1:42 to 1:46

HPIE Day 1: Friday,17th September, 2021- Healthcare Planning & Infrastructure Expo and Conference - See 3:09 to 4:07 

Improving process standards in healthcare webcast

APICON 2015 presentation by Dr Pankaj Gupta 19Feb2015 Gurgaon

Elets Exclusive: How TeleMedicine is Being used on the Frontlines of the Coronavirus Crisis

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Panel Discussion: Transforming Healthcare Ecosystem Post Covid-19

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DR PANKAJ GUPTA | VOICE OF CHANGE

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National Digital Health Mission [NDHM]

National Digital Health Mission launched by PM Modi from Red Fort on 15th August 2020. ABPMJAY set the stage in 2018. Now India is taking the next big Digital Health leap in 2020. NDHM will serve as the Digital backbone for Health Insurance and the Provider Healthcare Ecosystem. https://lnkd.in/dsRK3te

I had coined the term national ehealth authority [NeHA] in 2011 while doing the public health IT study report together with national health systems resource center [NHSRC]. I then spoke about NeHA, HIE and NHIN at the WITFOR 2012. I again spoke about NeHA, HIE and NHIN @ the eHealth conference Hyderabad 2012. I then wrote about it in the meta data and data [MDDS] standards for health domain again in 2013. On 30th Dec 2016 MDDS had been notified as part of the EHR v2 2016. Aug 2018 - MDDS for Health had been Notified. Nov 2019 - NDHB carried forward MDDS for Health and recommended the creation of NDHM.

#NDHM vision is to create a national digital health ecosystem that provides access to efficient, accessible, inclusive, affordable, timely and safe healthcare for all citizens.

Clearly India is moving from a payout-of-pocket model to a Universal Healthcare Coverage model. About 60% of India's population will soon be covered as all Govt Health Schemes are folding-in to ABPMJAY and the Missing-Middle is all set to be covered too. Total claims are set to go up by 10-13 times. Digital is the only way to manage the upcoming Tsunami of claims.

World over Health Insurance does not just pay for Secondary and Tertiary care; it is in the interest of Health Insurance to reduce the overall Disease burden. Digital will help us catch the disease earlier at Primary care levels. Will better manage the Referral network. Data driven Clinical Protocols to slow down the disease progression. Evidence based medicine to reduce the disease burden. Some Examples - John Hancock shifts from Life Insurance to Disease management; CVS purchased Aetna; UnitedHealth bought a large Doctors Group. ICICI Prudential Life Insurance covers Critical illnesses. 

Healthcare Wallet will Emerge: Soon a level playing field will enable a Healthcare Marketplace to emerge, to help the Person make better choices on Hospitals, Doctors, Appointments, Pharmacies, Labs and more. Patients will be inundated with plethora of choices and price competition will play out for them just like it happened in Telecom, Airlines and Retail.

Covid19 did not break the Healthcare system, it only exposed a broken system. Today Public Health cant do resource optimization because they don't really know how many Doctors, Nurses, Beds, Hospitals, Assets exist. This is not going to be the last epidemic hitting us. In this Pandemic, and Next time around we will be better prepared with resource optimization tools, predictive analytics and armed with Epidemiological studies to tackle it. 

NDHB Standards Compliance: To comply with NDHB Standards, the Health System has 2 options:

For Legacy systems - apply the eObjects published here with FHIR Extensions and JSON. https://openhealthcode.blogspot.com/2020/04/provider-eobjects-published.html

For new systems - please build the Standards into your information model. https://openhealthcode.blogspot.com/2020/06/hdis-mvp-microservices-published.html Health Delivery Information System MVP Microservices published in #opensource. It is Free. Anyone can use the code under MPL 2.0 #opensourcesoftware license. Our objective is to take the Digital Healthcare Ecosystem to the next level.
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Summary - Telemedicine Practice Guidelines

 

Doctor friends,

Telemedicine guidelines now allow you to do everything. Just be careful; Liability is on you now, so:

• Do not step out of your clinical comfort zone;
• Keep all the past and present records - Text, Audio, Video, Paper, Films etc. It is mandatory to keep records. Also the records provide a legal cover to the medical practitioner in case of any MLC.

Telemedicine guidelines have solved all the old issues:

• Any Consultation without Physical Examination was not allowed.
• Telemedicine needed Healthcare professionals on both sides of the Electronic Line.
• Only Triage was allowed over a Voice call.
• ePrescription was not allowed. MCI insisted on physically signed prescriptions.
• Online Pharmacy delivery without verification of physically signed prescriptions was not allowed.
• As per MCI, Patient walking into the Physical clinic is considered as Deemed consent. Law did not interpret the same for Telemedicine calls.
• Guidelines were silent on Consent, privacy and data security.
• Telemedicine service providers had to be registered with respective States under the Shops Act and Clinical establishment Act.
• MCI Contributory Negligence Clause included the Telemedicine software and service providers also i.e. they also had to share the legal Liability.
• Access and Availability.

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Technology Requirement:

• Cloud First Design: Gone are the days when you needed a big technology infrastructure for Telemedicine setup. Just host your App on the cloud.
• Mobile First Design: Now in the FAANG Digital era, all you need is an EMR on your mobile with a Text/ Audio/ Video calling plugin like Skype, WhatsApp, Team, Meet...etc.
• EMR is Mandatory: Make sure the EMR output is in compliance with the NDHB/EHR/MDDS Digital Health Standards. EMR should have ability to push the medical records to a National PHR whenever it becomes available.
• Connectivity: Internet 4G is required for Video calling. Internet 3G is enough for Audio calling and Text Consultation.

Functional Requirements as per Digital Health Policy of India:

• Patient demographics & encounter / visit clinical summary should use the government published libraries of data elements & code directories from MDDS_EHR standards. There are 1000 + data elements and 144 code directories defined and available in PDF format to be used by application developers. (XSDs, CSV, JSON, XML formats for the same are available with Access Health International in open source)
• Diagnosis & chief complaints- Diagnosis & chief complaints to be captured using WHO- ICD 10 code list.
• Clinical Notes- SNOMED CT codes to be used that are published and available with NRCeS on their website with tools for implementation.
• Lab & radiology Investigations- LOINC mapped with local investigation codes are to be used for all investigation orders to be paced through an EMR.
• Procedures (non-diagnostics & radiology procedures) - SNOMeD CT is recommended to be used for creating/prescribing any procedure order for the patient. A telemedicine provider can download and use free SNOMeD codes for India by registering on NRCeS website.
• Drug Prescription- An electronic prescription is required to be generated with a prescribing physician licence ID using NFI recommended Generics or Indian Drug Extension available on NRCeS website in SNOMed format.
• Referral Management- Solution shall support an electronic referral and an E-referral note with standardized digital visit/encounter summary to facilitate "continuum of care" with futuristic place holders for Facility & doctor registry lookup services.
• Health Information Exchange- NDHB recommends FHIR resource 4 to be used for clinical & health claim information exchange between providers and payers with indian specific semantic & terminology standards.
• Note- A FHIR compliant Digital clinical summary structure & design (electronic encounter note ,electronic referral note and electronic prescription note) as per telemedicine guidelines & MCI guidelines, are readily made available in JSON format on www.openbodhik.in

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Relevant Clause by Clause Summary - Telemedicine Practice Guidelines - 25 March 2020

This constitutes Appendix 5 of the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation, 2002Definition:‘The delivery of health care services, where distance is a critical factor, by all health care professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment and prevention of disease and injuries, research and evaluation, and for the continuing education of health care providers, all in the interests of advancing the health of individuals and their communities.'

With telemedicine, there is higher likelihood of maintenance of records and documentation hence minimalizes the likelihood of missing out advice from the doctor and other health care staff. Conversely, the doctor has an exact document of the advice provided via tele-consultation. Written documentation increases the legal protection of both parties. <Interpretation>: Keeping Electronic Medical Records is now mandatory.

help patients adhere better to their medication regimens and manage their diseases better. Telemedicine can also enable the availability of vital parameters of the patient available to the physician with the help of medical devices such as blood pressure, blood glucose, etc management.

Unnecessary and avoidable exposure of the people involved in delivery of healthcare can be avoided by using telemedicine and patients can be screened remotely.

India’s digital health policy advocates use of digital tools for improving the efficiency and outcome of the healthcare system and lays significant focus on the use of telemedicine services, especially in the Health and Wellness Centers at the grassroots level wherein a midlevel provider/health worker can connect the patients to the doctors through technology platforms in providing timely and best possible care. <Interpretation>: Telemedicine Guidelines have to be read in conjunction with and will be governed under the ambit of India's Digital Health policy i.e. NDHM, NDHB Standards, EHR Standards and MDDS Standards for Health.

However, there has been concern on the practice of telemedicine. Lack of clear guidelines has created significant ambiguity for registered medical professionals, raising doubts on the practice of telemedicine. The 2018 judgement of the Hon’ble High Court of Bombay had created uncertainty about the place and legitimacy of telemedicine because an appropriate framework does not exist. <Interpretation>: All the ambiguity is now removed.

In India, till now there was no legislation or guidelines on the practice of telemedicine, through video, phone, Internet based platforms (web/chat/apps etc). The existing provisions under the Indian Medical Council Act, 1956, the Indian Medical Council (Professional Conduct, Etiquette and Ethics Regulation 2002), Drugs &Cosmetics Act, 1940 and Rules 1945, Clinical Establishment (Registration and Regulation) Act, 2010, Information Technology Act, 2000 and the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data or Information) Rules 2011 primarily govern the practice of medicine and information technology. Gaps in legislation and the uncertainty of rules pose a risk for both the doctors and their patients.

It also spells out how technology and transmission of voice, data, images and information should be used in conjunction with other clinical standards, protocols, policies and procedures for the provision of care.

1.3.3 - All registered medical practitioners intending to provide online consultation need to complete a mandatory online course within 3 years of its notification. <Interpretation>: RMP must be trained on Telemedicine course within 3 years of this notification

1.4 - Classification of Telemedicine:
Communication - Real time vs Asynchronous
Purpose - First, Follow-up, Emergency
Individuals - RMP, Health worker, Caregiver, Patient

2.0 - Limitations of Telemedicine: <Interpretation>: It is difficult to establish the ID of the Patient and the RMP over Video/Audio/Text. Hence proper and sufficient ID proof has to be presented from both sides. Patient identification needs to be clearer, greater chance of imposters representing the real patient over a Audio Call. It is difficult for the RMP to do a Physical Examination. Only possible when there is a Healthcare Worker on the other side also.

3.0 - The professional judgment of a Registered Medical Practitioner should be the guiding principle for all telemedicine consultations: An RMP is well positioned to decide whether a technology-based consultation is sufficient or an in-person review is needed. Practitioner shall exercise proper discretion and not compromise on the quality of care.

3.2.2 - An RMP should verify and confirm patient’s identity by name, age, address, email ID, phone number, registered ID or any other identification as may be deemed to be appropriate. The RMP should ensure that there is a mechanism for a patient to verify the credentials and contact details of the RMP.

3.4.1 - If, the patient initiates the telemedicine consultation, then the consent is implied [Similar to Physical In Office Consultation]

3.4.2 - An Explicit patient consent is needed if: A Health worker, RMP or a Caregiver initiates a Telemedicine consultation.

3.5.1 - An RMP would use his/her professional discretion to gather the type and extent of patient information (history/examination findings/Investigation reports/past records etc.) required to be able to exercise proper clinical judgement. This information can be supplemented through conversation with a healthcare worker/provider and by any information supported by technology-based tools. If the RMP feels that the information received is inadequate, then he/she can request for additional information from the patient.If a physical examination is critical information for consultation, RMP should not proceed until a physical examination can be arranged through an in-person consult. RMP shall maintain all patient records including case history, investigation reports, images, etc. as appropriate. <Interpretation>: Data of the Current Consult and sufficient data of the past is required for providing the Consult. Digital or Non-Digital Data has to be kept by the RMP. How much Information required is Left to the discretion of the RMP but it has to be sufficient to support the diagnosis and treatment plan.

3.6.2 - Follow-Up Consult(s) means - The patient is consulting with the same RMP within 6 months of his/her previous in-person consultation and this is for continuation of care of the same health condition.

3.7.1 - If the condition can be appropriately managed via telemedicine, based on the type of consultation, then the RMP may proceed with a professional judgement to:
Provide Health Education as appropriate in the case; and/or
Provide Counseling related to specific clinical condition; and/or
Prescribe Medicines

<Interpretation>: RMP can prescribe Medicines over a Telemedicine Consult.

3.7.4 - Prescribing medications, via telemedicine consultation is at the professional discretion of the RMP. It entails the same professional accountability as in the traditional in-person consult. RMP may prescribe medicines via telemedicine ONLY when RMP is satisfied that he/ she has gathered adequate and relevant information about the patient’s medical condition and prescribed medicines are in the best interest of the patient. Hence, Prescribing Medicines is Left to the clinical judgement of the RMP as per the guiding lists given below:
List O - OTC with Any kind of communication mode.
List A - Re-Fills and reasonably safe medication after Video Consult.
List B - Follow-Ups with Any kind of communication mode.
Prohibited - Potential for Abuse, Scedule X, Narcotics etc. can not be prescribed.

3.6.4.2 - Prescription Format is given in the Annexure. RMP shall provide photo, scan, digital copy of a signed prescription or e-Prescription to the patient via email or any messaging platform o In case the RMP is transmitting the prescription directly to a pharmacy, he/ she must ensure explicit consent of the patient that entitles him/her to get the medicines dispensed from any pharmacy of his/ her choice. <Interpretation>: ePrescription is explicitly allowed. No need for physical signatures in ePrescriptions. RMP has to obtain explicit Consent of patient before sending ePrescription to the Pharmacy.

3.7.1.2 - Registered Medical Practitioner would be required to fully abide by Indian Medical Council (Professional conduct, Etiquette and Ethics) Regulations, 2002 and with the relevant provisions of the IT Act, Data protection and privacy laws or any applicable rules notified from time to time. Interpretation: All Telemedicine controls to be built as per IT Act, Data Privacy and Data Security regulations etc.

3.7.1.3 - RMP Protected from breach if the breach is attributable to Technology or a person other than the RMP. The RMPs should ensure that reasonable degree of care undertaken during hiring such services.

3.7.2 - MAINTAIN DIGITAL TRAIL/ DOCUMENTATION OF CONSULTATION: It is incumbent on RMP to maintain the following records/ documents for the period as prescribed from time to time. Log or record of Telemedicine interaction (e.g. Phone logs, email records, chat/ text record, video interaction logs etc.). Patient records, reports, documents, images, diagnostics, data etc. (Digital or non-Digital) utilized in the telemedicine consultation should be retained by the RMP. Specifically, in case a prescription is shared with the patient, the RMP is required to maintain the prescription records as required for in-person consultations. <Interpretation>: RMP is responsible for Maintaining Digital Trail or Documentation including Logs, Digital or Non-Digital patient records.

3.7.3 - RMP can charge a reasonable Fee for Consultation and should provide a receipt for the Fees.

4. - Telemedicine envisaged in 5 scenarios:
Patient to Registered Medical Practitioner
Caregiver to Registered Medical Practitioner
Health Worker to Registered Medical Practitioner
Registered Medical Practitioner to Registered Medical Practitioner
Emergency Situations

<Interpretation>: In 3 and 4 physical examination is possible. Gives greater visibility into the disease condition of the patient. RMP can prescribe medicine with more confidence.

5.4 <Interpretation>: Artificial Intelligence not allowed to Consultation. Artificial Intelligence can at best be an assistant the RMP.

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Points to Ponder:

• Telemedicine guidelines have Equated Telemedicine Consult with Physical in office Consult. All laws and regulations that apply to physical in-office Consult will now apply to Telemedicine Consults also.
• All Liability is now on the Medical Practitioner. So commensurate Standard Treatment Guidelines [STG] should emerge. STG have to emerge for prescribing List A, B drugs.
• Mandatory for Medical Practitioner to keep sufficient Medical records, of current and enough records of the past. In other words the Telemedicine marketplace has to get together to build an interoperability framework across facilities and geographies to enable the longitudinal patient health record [PHR].
• RMP absolved of Liability if problem attributed to Technology - So Contributory negligence for Telemedicine software and service provider should also be spelt out.

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Telemedicine Notes shared by Dr Pankaj Gupta for the Medical Fraternity

Health Systems for a New India: eObjects #Opensource Building Blocks

 

Here is a sequence of events over the last 8-10 years that lead to the #Opensource eObjects.

India has been majorly a paper-based Healthcare System. However, there have been pockets of success in transforming paper-based processes to electronic systems. Max Healthcare was one such initiative that took a leap of faith well before the rest of the market could even think in that direction. I happened to be part of that journey with an eclectic team that got dispersed at the end of the project but continued the journey in their individual capacities. Who could think then that such small individual efforts could come together later for the transformation of the country as a whole? It probably happens once in a lifetime. Serendipity positioned a very strong National leadership that could collate all these pieces together for building the National Digital Health Blueprint.

It all began when Max Healthcare partnered and outsourced its IT infrastructure support to Dell Services formerly Perot Systems in September 2009 for developing and maintain their IT operations across all Max Hospitals in India. This unique partnership provided significant value to Max in terms of enhancing the quality of services and reducing the treatment costs. While doing the transformation at max healthcare the team stumbled and fell and then learnt to walk again. For India the full implementation of EHR, Registries, Meta Data, Master Code Directories and Interoperability were seen first time in action here. Max Healthcare gave invaluable learnings of applying the global standards and architectures to Indian settings, something that had never been done before!

Looking at the successful transformation of Max Healthcare, Perotsystems was contacted by the Ministry of Health India to conduct current IT systems study in health sector in India and do the health checks. Due to merger of PerotSystems and Dell Services, Dell Services could not undertake the task. Later I picked-up that work and submitted the Public Health IT Study Report through Sector Innovation Council on Health, India. Since it was not possible to study every system being in use in a country like India, I and my team picked up the representative set that was diverse enough to extract critical findings that needed immediate attention. Later these findings and recommendations from the Public Health IT study became important part of Twelfth Five Year plan.

Setting up Meta Data and Data Standards was an initiative taken by the Ministry of Electronics and Information Technology under National e-Governance Plan (NeGP). It intended to promote the growth of e-Governance within the country by establishing interoperability across e-Governance applications for seamless sharing of data and services. Domain-specific committees were constituted under MDDS initiative. MDDS for Health Standards committee was one such initiative, which was constituted on September 2012 under the chairmanship of Joint Secretary MoHFW in pursuance of communication received from Secretary, Ministry of Electronics and Information Technology (MeitY).

Role of Meta Data and Data Standards in Primary and Public Healthcare
MDDS for Health Data Dictionary
Facility Registry: NIN HFI Project Report
National Digital Health Blueprint

eObjects were first written by Prof Dennis Streveler and Dr Pankaj Gupta in a white paper in Nov 2018 that was published by Niti Aayog in the book Health Systems for New India, Chapter 5 - Reimagining India's Digital Health Landscape Wiring the Indian Health Sector in Nov 2019.

ACCESS Health Digital Strategy Council defined the details of the NDHB building blocks - Minimum viable products including the eObjects and microservices architecture to comply with the NDHB Standards. ACCESS Health Digital runs a Social Entrepreneurship Accelerator to accelerate the implementation of the NDHB Standards through these building blocks.

The eObjects have now been adopted by Joint working Group of National Health Authority NHA and Insurance Regulatory Development Authority IRDAI Sub group on common IT infrastructure, in its report published on 11 Sep 2019 and will be built into the India’s national Health Claims platform.

The eObjects were designed for interoperability across the healthcare ecosystem on a federated architecture. eEncounter, eDischarge Summary Objects are for Provider-to-Provider interoperability; such that the data can flow across healthcare facilities, State HIE and National Data Lake. Whereas the eClaims Object creates a Financial Lever for the market. If the providers submit the claims in standard eClaims Object format then the turnaround time for their payments can be expected to be faster. Clearly eObjects are an innovative breakthrough.

This is very similar to what happened in the FinTech revolution in India where Government of India created the Unified Payment Interface UPI platform and then created the BHIM App and released the related Application Programming Interface APIs to the market. Later the Market used the API’s and built the hugely successful Paytm, Googlepay, Phonepe wallets. In 3 years the UPI transactions went from negligible to 1 Billion transactions per month.

Financial lever and strong governance for digital health transformation, plays a vital role in ensuring successful outcomes of such undertakings. India would do well to heed this truth.

My ACCESS Health Digital team got an eGovernance Award for the work.

The details of eObjects are published in #Opensource under MPL 2.0 #Opensourcesoftware license on OpenBodhik blog: www.openbodhik.in
FHIR based eObjects published in CSV/XML/JSON
Library of 1000 Data Elements and 140 Code Directories published in XSD
National Formulary of India - Generics Drug List Published in CSV
Healthcare Delivery Information System [HDIS] Minimum Viable Product [MVP] Definitions and Microservices Code Published

eObjects also published by ExpressHealth

eObjects referenced extensively by Nachiket Mor in his paper and book published by John Hopkins USA