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.

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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.

10th Elets Healthcare Innovation | Technology in Healthcare pushing the Atmanirbhar Bharat Mission

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

Dr Pankaj Gupta speaking @ IoT Grand Slam

Learnings : Teleconsulting - Changing Paradigms

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DR PANKAJ GUPTA | VOICE OF CHANGE

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eINDIA 2012 Health Summit eHealth mHealth Dr Pankaj Gupta

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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

India Leads the Way in Digital Health

 

India is in the midst of what some have dubbed the “world’s biggest healthcare overhaul.” In addition to recently launching one of the world’s largest publicly funded health insurance programs, set to cover some 500 million people living in poverty, the government has also been working diligently to develop a new digital health strategy for the nation.

The work on the strategy began more than five years ago, when the Ministry of Health and Family Welfare and the Ministry of Communication and Technologies developed a new set a metadata and data standards for health – essentially a common set of standards for the collection, creation, and coding of all health data that can be easily transferred across computers and information systems anywhere in the country. The standards were based on global best practices but adapted to better serve the local context. Previous to its work on data standards, the government also developed a system to allow it to issue a National Identification Number to all healthcare facilities in India.

These efforts have now put the government of India in a position to launch a new National Digital Health Blueprint. The blueprint, which is now open for public comments and consultations, validates the six pillar strategy that ACCESS Health has advocated for, namely:

1. A governance methodology and framework to help the digital health blueprint bring balance between patient privacy and scale.
2. Highlight the value and role of standards-based system design, including meta data and data standards for health, the health data dictionary, and registries.
3. A Health Delivery Information System to better manage healthcare provider operations, including software for patients medical records.
4. A Health Insurance Information Platform to provide better underwriting support for government schemes and to manage fraud and risks.
5. Electronic Health Records and a Health Information Exchange to provide citizens access to their health records and allow policy experts to understand disease burdens patterns.
6. Information and communications technology for infrastructure and capacity building to support digital health transformation.

A number of key members now on the ACCESS Health Digital Health team previously worked on the metadata and data standards initiative and on developing the national identification numbers. Their work was carried forward in the national blueprint.

In addition to its impact in India, the work the government has undertaken is likely to become a model for other emerging nations. The blueprint highlights some of the key points that ACCESS Health believes should be a part of any national digital health strategy. These include:

The need for federated governance and technology models to reflect the healthcare system, given that healthcare in India is a state-related subject;

The need to shift focus to more preventive medicine via a focus on strengthening the primary healthcare system and promoting alternative schools of medicine;

The importance of issuing of a personal health identification number that allows consent-based identification and portability of medical records across the continuum of care;

The importance of a mobile-first design approach that recognizes the growing penetration of telecommunication links on the back of low data tariffs;

The need for a data-driven approach to health policy making that recognizes the role of disease registries for accurate capturing of health burden; and

Recognition that there’s a need for keeping citizens healthy and productive to achieve economic growth as sick citizens become a burden on the system.

ACCESS Health Digital team looks forward to supporting the Government of India in its ongoing efforts to develop and implement this critical new strategy to improve health in the country.

https://accessh.org/india-leads-the-way-in-digital-health/

Healthcare Wallet will Emerge!

 

Healthcare Wallet will Emerge!

India is poised for 10 fold increase in digital payments. Will become 4th largest in the world after Singapore, Sweden and USA. This will have a profound impact on Digital Health. Will become a major driver in adoption of Digital Health across payer and provider systems.

Consider This:

Health Insurance coverage has gone up from 3% of Indias population to over 40% with Ayushman Bharat.

90% of Health Insurance claims is reimbursement of out of pocket out patient expenses related to the inpatients episode.

Insurance is more comfortable reimbursing a Digital expense because it reduces the chances of fraud and abuse. From a Actuarial perspective the risk comes down because of full traceability.

Patients will gravitate toward clinics and hospitals that provide Referrals, Prescriptions, Reports in Standards based electronic format. Because Insurance companies will clear the standard eClaims format faster.

About 8% of out patient gets converted to inpatient procedures for any hospital OPD. Any reduction in out patient foot fall will negatively impact the inpatient load and hence the top line.

A Fintech based rating engine will appear to rate the clinics and hospitals. This rating engine will be far more pervasive than the Practo rating engine because money in the pocket is always a more powerful driver.

A whole new sand box gets created for the digital health startups, software vendors and fintech companies to play. Someone will fill the vacuum. For lack of a better word a Paytm or Jio Wallet for Healthcare expenses and reimbursements is on the anvil.

India will be the next battleground for Global Retail and Healthcare! After USA, India has the largest user base for the Internet Giants like FB and Google. Amazon is in India. Walmart is picking up majority stake in Flipkart. All the Internet and Retail giants have expressed interest in Healthcare.

Can you extrapolate the Dots? I can see the Trend! Fintech fueled transformations are underway.

The real innovation in mobile payments in India began a few months prior to the cash ban. It’s called a unified payment interface, or UPI.

With more than 140 Indian banks sharing the interface, and Alphabet Inc.’s Google and Facebook Inc.’s WhatsApp offering instantaneous payment services on it, UPI has become a keenly watched experiment. By the looks of it, things are going well: From nothing to 800 million monthly transactions in less than three years, India’s UPI has taken off. Growing smartphone use and crashing data costs have helped immensely.

Google and WhatsApp will fight for market share. So will PhonePe, now owned by Walmart Inc. as well as new entrant Amazon Pay, which hasn’t made much of a dent globally into PayPal’s dominance of e-commerce. Indian banks that run their own UPI services. Indian tycoon Mukesh Ambani’s Jio with its 300 million subscribers will push JioMoney. Masayoshi Son and Warren Buffett will keep an eye on their Paytm stakes.

Now RBI has removed charges on RTGS/NEFT transactions; and asked banks to pass on benefits.

Cities Perspective:

Tier 1 cities: Pune, Bengaluru, Chennai are leading the wave in UPI transactions. Pune topped the city list, with the highest average digital spend — per person per month — of ₹16,513. Followed by Chennai at ₹14,208 and Bengaluru at ₹14,000.

Tier II and III Cities: Razorpay says by 2020, 40 per cent of digital payment transactions in the country will be driven by businesses and consumers in Tier-II and -III cities, and 50 per cent of internet users will be using digital payments. Whereas Paytem says - We have been witnessing a tremendous increase in adoption of digital payments in tier II & tier III cities that constitute 50% of our total user base. Surat, Durgapur, Rajkot, Meerut, Imphal, Rohtak, Panipat, Mangalore, Ranchi, Puducherry, Rajamundri, Warangal, Jodhpur, Thrissur, Karnal, Madurai and Jamnagar are among the fastest adopters and are leading the wave of digital payments adoption.

Users of wallets are not updating their KYC (know your customer) details. Instead, they are using UPI (Unified Payment Interface) to make digital payments. Anyhow total payments via digital instruments are expected to be between $400-500 billion in 2020, up from $50 billion in 2017.

Hold your breath guys! Fintech is the digital health roller coasters.