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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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/

Effect of Demonetization on Healthcare

Demonetization is a master stroke by PM Modi. It has done to Healthcare what all Transformation consultants put together couldn't achieve in 75 years.

These are few of my observations. Maybe isolated incidents and may not represent a wider trend; But this is what I saw...'pratyaksh athwa pramanit'.

1. Cash payments in Hospitals have gone Digital! Patients come and say 'cash nahin hai saab ji'. Hence acting as a filter between need and want. Will pay Digitally for only what is required and not what can be postponed. What was under the table has come overboard. Only 5% of the GDP is spent on health and 80% of this is in the form of out of pocket expenditure. Almost all of this out of pocket was cash; out of which I think 70% will get converted to Digital that will show in the books and attract relevant tax. Over 80% bed utilization is usually considered profitable. However I have seen bed utilization falling by 30% in the demonetization period. I think this could be a short term shock effect, hope not a long term trend!
2. The biggest impact is on Doctors in private practice for primary and secondary Healthcare. They can no longer hide some of the cash payments. Their cut practice will stop or be washed overboard. Labs, Pharmacy, Specialists, Hospitals have stopped paying cash [cuts] back to the practitioner. 'aap ko pata hai, cash to ab hai hi nahin Doc saab'. As per some estimates cut practice forms 80% of their income but hidden from income tax. About 60% of total health expenditure in India was paid by the common man from his own pocket. Almost all of this out of pocket was cash, out of which I think 70% will get converted to Digital that will show in the books and attract relevant tax. 
3. Sales of OPD prescriptions and OTC has become Digital! Pharmacies were already geared for Digital payments but now the % of Cash payments has gone down to minimal. This is a good thing because now the traceability of the sale has gone up. Each transaction has a unique number and can be traced by batch number. Out of all health expenditure, 72% in rural and 68% in urban areas is for buying medicines for non-hospitalised treatment. Almost all of this was cash, out of which I think 70% will get converted to Digital that will show in the books and attract relevant tax. 
4. IPD Medicines are fully Digital now. Whatever came through the HIS was Digital anyways. Now the medicines being bought directly by the patient are also Digital. Soon Pharma companies will have access to reliable Digital data for forecasting, which was a struggle thus far. Organised retail Pharmacy stores can handsomely monetize this Digital data.
5. Hospital consumables and materials are about 30% of the operations cost; where the procurement has gone Digital! Where is the cash to pay for all the material supplies? Hence forced to do direct funds transfer to the bank.
6. Medical consumables and material supplies to primary care and secondary care sector were all cash transactions. Now becoming cashless online payment. Small material suppliers risk getting wiped out as their business margin [< 8%] is lesser than the total tax liability!
7. Although P&C/Gen Insurance saw heavy FDI inflow after the amended law last year; but same didn't happen to Health Insurance thus far. This is because the Actuaries can't calculate the risk when the Indian Healthcare relies on hidden cash transactions and under the table deals. It's happening now because of demonetization. Insurance feels more comfortable dealing with claims that have a Digital footprint. i.e. 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. Full traceability. Hence I saw a large Healthcare group offering OPD Insurance cover. Now that is a commendable change! Thus far private Health Insurance coverage is between 3-5% and total Health Insurance coverage is between 14-18% of India's population; this is expected to grow exponentially because insurance becomes attractive in a clean business environment.
8. MNC Medical device OEM want to sell directly in India now. Not through dealers because the payments have become Digital and 100% FDI is allowed and overboard. As per FICCI the Medical Devices and Equipment industry, valued at US$ 2.5 billion contributes only 6% of India’s US$ 40 billion healthcare sector. It was growing at a annual rate of 15%. The need for Digital records, Digital payments and with IoT coming in, I expect it to grow @ over 20% annually.
9. Labs were already Digital ahead of other Healthcare stakeholders. Now thinking of leapfrogging to SMAC, IoT, Automation and AI in a big way. LOINC standardsapproved and notified for India! International Lab chains eyeing India as a viable market.
10. Radiology business is falling. Unnecessary imaging is going down. Traceability and transparency is reducing repeat tests. Obviously Patient benefit and Insurance wins.
11. Drug counterfeit market that was expected to be 50% of the market in India has been hit badly as it was all cash market. Pretty much struggling to survive. Obviously plugging such a leak is a huge benefit for all. Recognised Pharma companies should be celebrating. The total yearly drug spend of US$ 36.7 billion currently should see a huge jump this year as the market spend shifts from counterfeit to genuine drugs. It will be interesting to watch if this shift will benefit generic or patented drugs!
12. All the ad-hoc or lower level staff were daily wagers and are on daily or weekly cash payments. No one really knew if these daily wagers were real or existed only on paper. Salary payments under 30K per month did not attract TDS and hence were mostly used as a buffer or to siphon the black money. Now the ordinance of all Salary to be paid Digital brings all this out in the open! Going forward 'Ram lal 1, Ram lal 2, Babu Ram x, Babu Ram y' will no longer exist.
13. National Health Protection Scheme - Health Insurance cover of up to INR 1 Lakh per family for the poor and BPL has been hanging fire for a year now; But PM Modi announcing INR 6K direct benefit transfer [DBT] for every pregnant woman in the country is the last straw on the corrupt public healthcare systems back. The Govt will need to establish unique Digital Identifiers and registries for Services, Patient, Provider and Facility; hence EHR v2 and MDDS Standards notified. Where the DBT will be done by Jandhan, AADHAAR and mBanking [JAM]. This is start of the Public Health Transformation!
14. Real estate use for Healthcare is suddenly in demand! The dealers and builders are calling me and offering spaces at 75% discounted rentals, the same were unwilling to talk because they could get higher prices elsewhere. Now I tell them I dont have the cash to rent/buy.
15. Didn't you wonder - !! - when the balance sheets of large hospital/healthcare chains were showing losses year-on-year? Obviously this was a siphon going on. Demonetization wiped out the [black?] cash stores of HNI and traditional Indian business houses. Hence Demonetization has given a major blow to the investment confidence in green field and brown field hospitals and other capital intensive Healthcare businesses. Soon these siphon businesses will start getting sold out or wiped out of the game. Hence democratisation of funds creates a level playing field for new age digital healthcare business to compete with the old boys club. Let's bet on the winning horse now!
16. 80% of healthcare infrastructure is in public sector whereas 80% of healthcare spend is in the private sector. Majority of the spend in private sector was in cash. These cash based revenue sources for private Hospitals have taken a big hit. Value of volumes from Govt Insurance programs like CGHS, ECHS etc. have gone up. With demonetization and Digital payments the corruption is expected to come down significantly. Hence the public sector hospital functioning is expected to improve and give private sector hospitals a run for their money. Nalayak beta bhi ab layak ho gaya ;-)
17. India sovereign is now ready to become probably one of the largest Reinsurers in the world. Banking system is flush with unprecedented funds. Insurance companies will be fools to not notice! Health Insurance is no exception. Hence sets the stage for rolling out one of the world's largest Universal Health Coverage [UHC]. The number of Indians falling below the poverty line [BPL] every year due to health spending is anything between 2 to 7% of the nation’s population, and this total is on the rise. Hopefully UHC will stem this.

India's demographics playing in favor of shift to Digital payments. About 70% of India now is below the age of 40. Over 900 Million mobile phones in India. Over 60% are smart phones. AADHAAR has crossed over 1 Billion mark; its coverage is now at 93 percent among adults, 67 in children in the 5-18 age group and 20 percent of those aged zero to 5. Massive spread of Jan Dhan accounts, RuPay Cards in rural India, BHIM payment platform, Tax incentives for Digital payments, India's own GPS [NAVIC] are all preparations for the Digital onslaught on traditional lala and cash ka dhanda.

This year all balance sheets will show huge jump in revenue, assets and tax! win win for all. India will be soon ready for Universal Health Coverage! All the Healthcare MNC big boys are already eyeing India as it emerges from the shadows.

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Healthcare will have to learn Cashless Business! CBDT as per Amended Sec 285BA read with Rule 114E of The IT Rules 1962: has made it mandatory to report on Cash Transactions recorded on or after 01st April, 2016.

1. Tax Assessees (covered under the Tax Audit Norms) have to mandatorily report to the Authorities " Receipt of Cash Payments exceeding Rs. 2 Lacs for sale of goods or services of any Nature".

2. The FINANCIAL INSTITUTION must report cash Deposit or Cash Withdrawal (including through bearer cheques) aggregating valued to Rs. 50 Lacs or more in one F.Y. in one or more Current Account of any person."

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MAXimising Benefits

Max Healthcare IT Transformation Cover Story in Ehealth Magazine Eletsonline. Perot systems corporation Total ITO. Largest VistA EHR implementation outside the Veterans Health Administration (VHA) - U.S. Department of Veterans Affairs and outside the USA. The institutional memory of the grand success was lost in the merger of Perotsystems with Dell Services further merged with NTT Data. Though the success achieved in Max is unprecedented and still largely unmatched. Lot of firsts here. First Indian Hospital chain to go on a private cloud. All Hospitals working from the same HIS/EHR/LIS with common IDs for Patients, Doctors, Facilities. Records having Diagnosis, Procedure, Lab Standard Code Sets.

Published in eHealth Magazine : 01 October, 2010, Read the details

The IT outsourcing deal puts Max Healthcare on the roadmap for becoming the best IT-enabled hospital chain in the country The Indian healthcare system has recently realised the potential of information and communication technologies in completely transforming care delivery at hospitals. The industry witnessed its first complete IT infrastructure technology outsourcing deal in September 2009, when Max Healthcare and Dell Services (formerly Perot Systems) partnered for developing IT operations at all Max Hospitals. The cost of the deal, Rs 90 crore (excluding infrastructure cost), is an indicator of the increased priority that is now being given by Indian hospitals to IT, which is an extremely positive sign. As per the agreement, the deal will last for ten years, out of which one year has already passed, and a lot of positive transformation has already been noticed. The unique partnership is not only expected to provide a lot of value to Max Healthcare in terms of enhancing the quality of services and reducing treatment costs, but it will also be a great learning experience for Dell, which marked its entry into the Indian healthcare market with this deal.Status update Post its inception in September 2009, the ITO deal will last for 10 years and which, according to Dell, will comprise of three major phases – transition, improving productivity and optimisation.

As one year has passed, the transition phase is almost over. During this phase Dell installed the entire IT infrastructure for Max, by migrating the already existing IT infrastructure to a modern infrastructure. The entire data centre of Max, which was housed in their Okhla office, was migrated to the Dell facility in Noida. To reduce hassles, the shifting work was done during off hours on weekends, so that the work at the hospitals does not get affected. The entire process lasted for a couple of months and currently all Max Hospitals are running from the data centre housed in the Dell facility in Noida. The servers and network devices have been installed with monitoring devices that generate alerts in case a problem arises. There is also a situation management process in place to ensure that even the problems of highest criticality get resolved within a definite period of time.

Original publication for Reference: http://ehealth.eletsonline.com/2010/10/11436/

Summary of outcomes beyond the published article: Max Healthcare was the largest ever full ITO and Clinical Transformation Account of Perotsystems International. $20M deal across multiple years. Total Business Transformation done including technology, process, people and business. This includes Enterprise Architecture, Operations and Projects:

Phase I: Infrastructure Upgrade completed

1. Centralized Service Desk for L1 support and triage to L2 and L3 teams
2. Converted the P2P network to a MPLS private cloud
3. HIS and all other software applications of 7 Max hospitals are now running from the Dell data centre
4. HIS re-engineered and stabilized to take the load of new environment
5. Physical, Network and Data level security established
6. Operations management as per SLAs
7. Governance process for decision making
8. Integration with Medical Devices - ICU, ECG, EEG, LIMS, Lab Analysers, CT, MRI, Modalities, RIS, PACS, Surgery, Scopes etc.
9. Bar Code, Medication Administration and Nursing Devices
10. Computer on Wheels, Mobile CPOE Orders Devices
11. Retail Pharmacy, CRM, Physician Mobile, Remote Monitoring Devices

Phase II:

1. Customization of Opensource VistA Electronic Health Record System. Max Healthcare is the largest VistA implementation outside the VA and anywhere outside the USA.
2. Implementation of CPOE, CDSS, BCMA, ePrescription
3. Developed standard master data e.g. Service master, Lab master, Drug master, etc.
4. Order sets, Notes Templates
5. HL7 based Enterprise Application Integration using Mirth.
6. Clinical transformation as per ADOPTS methodology

Business Benefits realized by Max Healthcare:

1. Private Cloud IT Infrastructure: plug-n-play environment for new facilities
2. Business downtime due to infrastructure and HIS outages is history
3. Process Re-Engineering -- 1000 beds in 7 Hospitals; expanded to 1500 beds in 11 Hospitals.
4. Standardized operations without disruptions reduced the waste and improved the topline.
5. Near paper-less, > 95% Adoption in Clinical.
6. Achieved full NABH and HIMSS Stage 6 accreditations later.
7. Hospital was able to attract FDI investments.

The institutional memory of the grand success was lost in the merger of Perotsystems with Dell Services further merged with NTT Data. Though the success achieved in Max is unprecedented and still largely unmatched.

Read the details

Indian Pharma companies on US FDA lens

Why are so many Indian Pharma companies failing on Data and Quality standards and getting warnings that can lead to 483? Currently, 40+ Indian manufacturing sites are listed on FDA’s import alert list..

Global Supply-Demand issues: Indian Pharma is a major supplier of Generics to the world. If shun atleast 2/3 of the world runs a risk of demand-supply gap in Generics. Hence it is in the interest of UN, WHO and Developed Economies to help Indian Pharma climb the FDA compliance.

Cultural Issues: Traditionally Indian Pharma industries lack respect for Data and Quality paradigm. IT and Quality are the least paid and lowest in Hierarchy. Compare it to the Global Pharma MNCs where the IT and Quality hold Director or C-level positions.

Regulatory Issues: Highlighting weak regulation and monitoring of the domestic drug industry, three recently-introduced medicines are being prescribed and sold though there is a lack of rigorous trials on crucial safety and efficacy parameters. The pharmaceutical industry in India should face the same stringent regulations as elsewhere in the world, rather than continuing to allow patient safety to be put at risk by unproven drug treatments, says an article published in TOI. The Quality issues arise because Pharma Industry is under Ministry of Chemicals not under Ministry of Health @MoHFW_INDIA. This is a huge accountability gap in India. It will be in the interest of Public Health agencies like WHO and Global Fund and Global Pharma MNCs to demand the Dept of Pharmaceuticals to be located under the Ministry of Health with proper accountability established.

Data Reliability: Majority of the FDA observations are for relatively commonplace documentation or procedural issues...so many of the observations are for egregious errors like altering official documents in front of an inspector, or documenting important manufacturing or electrical data on scrap paper in pencil. Manipulated clinical trials data. “Generic” user accounts had been created in the Laboratory Information Management software system.

QA/QC Issues: Manager has admin rights on the software to edit or overwrite the data. Fudging of attendance records such as same employee working in 2 different sites at the same time. Even unauthorized QA document control stamps are reported. 

Other issues: Partially completed and/or unofficial training records. No response to consumer complaints. Incident reporting cover ups. 

References:

• FDA Form 483s From India: A Deep Dive Into the Problems: http://www.raps.org/Regulatory-Focus/News/2015/11/09/23562/FDA-Form-483s-From-India-A-Deep-Dive-Into-the-Problems/#sthash.bMMKjjGv.dpuf
• The Rs1 trillion FDA impact on Indian pharma: http://www.livemint.com/Companies/zcSsHW6iNvlulIW5K1qk9N/The-Rs1-trillion-FDA-impact-on-Indian-pharma.html
• Cadila Healthcare shares slump 15% on warning letter from USFDA http://www.financialexpress.com/article/markets/indian-markets/cadila-healthcare-shares-slump-over-15-on-warning-letter-from-usfda-december-31-2015/185907/
• Indians face risk from unproven drugs: Lancet http://timesofindia.indiatimes.com/india/Indians-face-risk-from-unproven-drugs-Lancet/articleshow/49029617.cms