India Is At A Very Critical Stage Of Novel Coronavirus Or COVID 19 Pandemic As Community Spread Is Taking Place

Update 1: Read the related article in this regard titled “Community Transmission Of Novel Coronavirus In India Is In Progress And Real Fight Would Begin Soon“.

Update 2: Today (05-04-2020) is the 12th days of national lockdown that is also coinciding with the community spread phase of novel Coronavirus or COVID19 in India. The lockdown has been imposed so that community spread can be suppressed under the guise of lockdown. After the community spread lockdown period of 21 days, almost 80% of Indian population would have already developed temporary immunity against the virus and only 20% would remain that would require serious medical care and hospitalisation.

Update 3: We at Perry4Law Organisation (P4LO) have already informed that the PCR test would become redundant for 80% of the population as due to forced and draconian lockdown, the community spread would have already resulted in creation of immunity among the 80% and their bodies must already have antibodies proving that they were infected by the community transmission and have recovered or are recovering.

Update 4: Now rapid tests (supplemented with PCR wherever needed) would be limited to only remaining 20% of the population and even among it the test would be targeted and focused upon hotspots and vulnerable areas and population only. So the remaining 80% population would neither face any problem nor would be subjected to any tests or treatments.

Update 5: Exceptional cases of serious illness and hospitalisation among the 80% population would be taken up for proper action in due course as it would remain subject to supervision, surveillance and tracing by the govt.

Update 6: Community transmission of novel Coronavirus is now subsiding in India and after the 21 days community transmission lockdown period, 80% of Indians would gain temporary immunity against the virus. But 20% population of India, especially the poor, migrant labours, etc, are more vulnerable to COVID19 infections and deaths. We at Perry4Law Organisation (P4LO) request Indian Govt to take special care of these vulnerable segments.

REQUEST UPDATE 7 (06-04-2020): Please read this update/caution very carefully. While 80% of Indian population may have already developed temporary immunity against COVID19 yet people are not risk free. This population may include people who are asymptomatic. This population may include people who would be re-infected. This population may include people who are still carriers. So entire India must take all precautions like washing hands, maintaining social and family distancing, wearing masks, etc for not only your own safety but also safety of others. 

Update 8 (06-04-2020): The temporary immunity that we have developed against COVID19 is not permanent at this stage. It may last for few months or a year. This temporary immunity may become permanent in future, either through multiple natural infections, recoveries and development of permanent immunity or through vaccination. However, we have to see who would be needing vaccination in future as it would become useless for majority of global population once it acquires permanent immunity. Vaccination is different from cure for a disease.

Update 9 (06-04-2020): There are chances that COVID19 may become a seasonal disease for few years or lifetime but our permanent immunity would be developed for the same, one way or the other. Just like common cold, it may trouble us after few years for lifetime or it may mutate further and disappear once the global population is infected and becomes immune to it.

Update 10 (11-04-2020): We have lost the containment and community transmission battles in India and now we must brace for the tragic impact. We at Perry4Law Organisation (P4LO) hope that the 21 days community transmission lockdown period was used by Indian Govt sensibly to strengthen the inadequate healthcare infrastructure of India.

Update 11 (11-04-2020): We at P4LO believe that continuance of complete lockdown would be a remedy worst than malady. We ignored testing and committed a big blunder, we ignored migrant workers and caused  big chaos. Our actions now onwards must be focused and practical in nature and not rhetoric like lockdown. 

Update 12 (11-04-2020): Stage 4 is activated when it is determined likely that COVID-19 is not contained. People stay at home, schools and all non-essential businesses are closed, rationing supplies and requisitioning facilities, limiting travel, etc. India is doing this for past 21 days as community transmission was already going on. 

Update 13 (11-04-2020): Community Transmission Stage Of Novel Coronavirus In India Is Already Over And Real Fight Would Begin Soon. We Are At Stage 4 And We Have Not Done Any Meaningful Testing So Far. This Gross Negligence Would Cost Us Many Lives.

Update 14 (12-04-2020): Almost 80% of Indians must have developed IgG antibodies as community transmission has been going on In India for long. The 21 days community spread lockdown period was imposed to contain that. We are now in stage 4, whether Indian Govt admits it or not.

Update 15 (12-04-2020): PCR tests would become useless for 80% of Indian population that has already developed antibodies due to community transmission lockdown period of 21 days. So PCR test would now be limited to 20% population, especially those living in slums, hotspots, quarantine centres, detention centres, migrant labours, etc. They are the vulnerable poulation that need urgent help and financial assistance.

Update 16 (22-04-2020): As predicted by us, Indian govt would no more conduct PCR tests for more than 80% of Indian population. Indian govt has already failed on the fronts of containment and community transmission stages/efforts and now the efficacy of its healthcare facilities would be tested soon.

Update 17 (22-04-2020): India was over relying upon the misguided and dangerous “Herd Immunity” concept that has put lives of many Indians in danger. Despite two draconian and useless lockdowns, Indian situation has not improved and cases of infections and deaths are rising sharply in India. India is facing highest death rate in the world for similarly situated countries vis-à-vis number of infections. Deaths in India were highest when we had 5000 infections and deaths in India are still highest when we have crossed 20000 infections. What has made this worst is that the testing rates of India are worst in the world and we are clearly underreporting both number of infections and actual deaths. Even Central Govt has shown suspicion about actual infections and deaths in West Bengal but that is not a State only issue. All over India neither we are testing enough people so there are much more infected people in India than shown nor we are reporting actual numbers of infections and deaths.

Update 18 (22-04-2020): While India failed on the front of PCR testing long back it has failed on the front of rapid tests as well. India has been using faulty testing kits that are giving false negative. While test accuracy of such kits is estimated to be 90% but in India their success rate is 5.4%, as reported by Rajasthan. West Bengal has also alleged that Central Govt has supplied defective rapid test kits to it. ICMR has suspended use of rapid test kits for two days and many States like Haryana have refused to use them temporarily. So as on date we have almost nil PCR and rapid testing in India.

Update 19 (22-04-2020): There is very bad situation at Indian hospitals. Patients with clear symptoms of COVID 19 are not tested by 90% of Indian hospitals. Even if they are tested and found positive, they are not immediately admitted for treatment and after much efforts they are admitted reluctantly. But the real problem arises here. Many patients have informed that hospital staff have ignored them completely. So bad is the situation that they are not getting even water for many hours/day. On lodging complaint by family members they are given false assurances that everything is fine and in many cases family members of such patients received the bad news of death of the admitted patients few days later. People are now cautious to go to govt and private hospitals due to lack of proper healthcare facilities and care.

Novel Coronavirus or COVID 19 is a pandemic that has made everybody in the world worried about it. The World Health Organisation (WHO) declared it a pandemic but the efforts and preparations of various nations are still not up to the mark.

We at Perry4Law Organisation (P4LO) started working upon a techno legal blueprint for the Coronavirus in January 2020 and offered our help to Indian Govt and PMO India too. We have been sharing our suggestions and insights regarding the novel Coronavirus continuously.

A very comprehensive thread has been created by me to discuss the past, present and future implications of novel Coronavirus that has received global applause and acceptance.

There are some crucial facts that have to be understood about novel Coronavirus. These are:

(1) It is a highly infectious disease that spreads through human-to-human transmission. This transmission can be aerosols or airborne based and medical professionals are at a severe risk of contacting the same through both modes/mechanisms,

(2) The fatality or death rate of novel Coronavirus is 3.4% as per WHO. However, it has been shown to be greater than that in many countries like Italy, Iran, etc. This is irrespective of the fact whether such countries have good or bad healthcare systems,

(3) Novel Coronavirus is “Asymptomatic” and people without any symptoms can and are transferring the virus to other people,

(4) Novel Coronavirus is more “Virulent” that other flu and that is why it is infecting so many people in such a short time,

(5) Nations are saying that novel Coronavirus has an incubation period of 14 days. In my personal opinion, it has an incubation period of more than 28 days and even in months. Cases of January 2020 are now visible in March 2020 in India and other jurisdictions,

(6) It is believed that novel Coronavirus can cause mild symptoms among 80% of the population and serious illness among remaining 20%. Out of this 20%, minimum 5% people would need intensive care unit (ICU) treatments,

(7) Novel Coronavirus can infect all age groups and there is no truth in the claims that only elderly people are vulnerable. From new born babies to people of 100 years of age, anybody can be infected, admitted to ICU and die,

(8) No country of the world has the capabilities to manage even 1% of the 5% population needing ICU support. India is more vulnerable due to big population and high density of population. For around 6 crore Indians, we just have 40000 ventilators, etc.

This list is endless but I cannot keep on going as I have to discuss a very crucial aspect of novel Coronavirus with Indians. Novel Coronavirus is neither a one time pandemic nor it can be contained by mere isolation. The most crucial action against novel Coronavirus is “Mass Testing” of people with symptoms and targeted medical facilities and services. Unfortunately, India lacks on both the fronts and as a result we have just locked a big percentage of global population at their homes who are already infected with novel Coronavirus.

While I support the containment actions but mere containment without any testing and medical support is a sure recipe of disaster that India just committed. At this community spread stage what we need is the following on priority and in same order:

(1) Provide masks, protective gears and adequate medical apparatus to our Doctors, nurses, medical staff and front line warriors. This includes people coming into direct contact with the infected patients,

(2) Build temporary hospitals with adequate beds so that the sudden surge in patients can be accommodated in the best possible manner,

(3) Arrange for more testing kits, ventilators, etc along with a good supply of medicines. Even basic and over the counter medicines must be in sufficient quantity as people would start panic buying the same soon. A quota must be set for the OTC medicines per person,

(4) General export of crucial medical equipments and medicines must be stopped by India. At the same time, countries in need of such medical equipments and medicines must be directly supplied the same through a dedicated plane in this regard,

(5) Lockdown has severe impact upon the Psychology of people and they would look for occasions to move out. A draconian restraint may be counter productive in India and the Govt must draft a techno legal policy to tackle this situation. Declaration of lockdown and imposition of Section 144 would not serve in the long run,

(6) Economy has taken a major hit due to novel Coronavirus. A relief package must be given by Govt. As we have limited financial resources, we at P4LO recommend that first priority should be daily wagers, poor and those living below poverty lines. We can revive industry and big players once we take care of the needy one. Ration of 2 months must be given free to such needy people so that they can stay at home and help in lockdown.

This article is part of the Techno Legal Blueprint of Perry4Law Organisation (P4LO) that we have released in public interest. More would follow soon.

PHRFC Has Been Recognised As A LegalTech, EduTech And TechLaw Startup By MeitY

Healthcare is a very wide field and it has many aspects. Legal compliance and adoption of technology are two of the most prominent aspects of modern healthcare ecosystem globally. This makes modern healthcare industry techno legal in nature and a healthcare stakeholder ignoring either is heading for a trouble. We at Perry4Law Organisation (P4LO) have been dealing in techno legal issues of healthcare for more than a decade and we are now in  a position to share our expertise with global healthcare stakeholders.

To make our efforts holistic and comprehensive, we enacted two legal entities recently. These are PTLB Projects LLP and TeleLaw Private Limited and they have been recognised as legaltech, edutech and techlaw startups by both DPIIT and MeitY. So our healthcare projects have now not only a legal backing but they have also been recognised as startups by highest possible authority of India in this regard. This makes taxation issues of angel investment and seed funding very easy and investor friendly. There would not be any angel tax on investments made in our healthcare startups.

One of our oldest healthcare projects is Perry4Law’s Healthcare Research and Facilitation Centre (PHRFC). We are proud to announce that it has recently been recognised as a startup by MeitY. So not only PHRFC is part of our existing startups but it has also been independently recognised as a techlaw, legaltech and edutech startup by MeitY.

Now that the basic background work has been done, we are now planning to officially launch it soon. It has a dedicated Twitter handle and more dedicated web resources would be launched soon. We are also in the process of seeking like minded collaborators and partners who are dealing in techno legal healthcare services. We are also looking for seed funding and angel investment for our healthcare startup. If you are interested in collaborating or funding our healthcare startup, please contact us in this regard.

We would also use latest technologies like artificial intelligence, block chain, internet of things, machine learning, big data, etc for our healthcare projects. Due to confidentiality of the same we cannot disclose the details to public at large at this stage. We hope national and global healthcare stakeholders would find our healthcare projects useful.

National E-Health Authority (NeHA) Of India May Be Constituted In Future

Healthcare can be significantly improved with the use of information and communication technology (ICT). Examples of combination of healthcare with ICT are e-health, m-health, telemedicine, online pharmacies, etc. However, with the use of ICT there are certain techno legal issues that have to be managed by various stakeholders especially the Indian Government.

As a matter of fact it is absolutely essential to formulate e-health laws in general and Digital India Laws in particular. Similarly, actual implementation of proposed or declared projects and policies is more important as otherwise polices and projects remain mere declarations. For instance, a proposal to constitute an e-health authority of India was mooted in June 2014. However, till August 2016 there is no sign of such an authority.

It is only now that the Union health ministry recently conducted a National Consultation on NeHA under the chairmanship of secretary, ministry of health, to give a final shape to the e-health authority. Obviously, it would take some more time, may be years, for the NeHA to be finally operational. Even then it is not clear whether the Indian Government would be able to provide a techno legal framework for NeHA with adequate procedural safeguards as till now that is missing from all its projects, including the Digital India. Perry4Law Organisation (P4LO) strongly recommends that such a techno legal framework must be formulated by Indian Government as soon as possible.

The Ministry of Health and Family Welfare has released a concept note discussing establishment of the National eHealth Authority (NeHA) for India in the past. According to the note, NeHA will be the nodal authority that will be responsible for development of an Integrated Health Information System (including Telemedicine and mHealth) in India, while collaborating with all the stakeholders, viz., healthcare providers, consumers, healthcare technology industries, and policymakers. It will also be responsible for enforcing the laws and regulations relating to the privacy and security of the patients health information and records.

Healthcare laws and regulatory compliances are long overdue in India. For instance, telemedicine and online pharmacies related regulatory issues are ignored by the e-health and m-healthy entrepreneurs in India. Websites selling medicines online are openly flouting the laws of India. Mobile application developers in India are also required to comply with privacy, data protection and cyber law requirements. These regulatory compliances are not adhered to by healthcare industry and entrepreneurs of India.

Similarly, healthcare cyber security issues in India are still not priority area for businesses and entrepreneurs. Healthcare industry is facing diverse range of cyber attacks these days. The prominent among them is ransomware that encrypts the sensitive healthcare information and decrypts the same only once the ransom is paid. So much is the nuisance these days that the National Institute of Standards and Technology (NIST) has released a guide for IT developers on integrating security measures into the development process, which could influence healthcare cyber security management.

Recently the cabinet approved the draft national IPR policy of India. This would facilitate intellectual property creation in favour of e-health and m-health entrepreneurs in India. This would also ensure that IPRs of others are not violated by the e-health and m-health entrepreneurs of India

Indian government has started ambitious initiatives like Digital India and Internet of Things (pdf) that intend to bridge the digital divide in India on the one hand and enabling e-delivery of services in India on the other. There are many segments of Digital India projects and e-health is one of them. E-health initiatives of India government aim at providing timely, effective and economical healthcare services to Indian population. E-health is particularly relevant for masses that have little access to healthcare services in India.

While the objectives of Digital India are laudable and deserve full support yet we at Perry4Law Organisation (P4LO) also believe that the shortcomings of Digital India project of India cannot be ignored or bypassed by Indian government. Similarly insisting upon Aadhaar number for healthcare services in India would be a terrible idea especially when Aadhaar is not mandatory for government services in India.

As per the concept note, NeHA would be responsible:

(a) To guide the adoption of e-Health solutions at various levels and areas in the country in a manner that meaningful aggregation of health and governance data and storage/exchange of electronic health records happens at various levels in a cost-effective manner,

(b) To facilitate integration of multiple health IT systems through health information exchanges,

(c) To oversee orderly evolution of state-wide and nationwide Electronic Health Record Store/Exchange System that ensures that security, confidentiality and privacy of patient data is maintained and continuity of care is ensured.

In the light of the above, NeHA has been envisaged to support:

(a) Formulation of policies, strategies and implementation plan blueprint (National eHealth Policy / Strategy) for coordinated eHealth adoption in the country by all players; regulation and accelerated adoption of e-health in the country by public and private care providers and other players in the ecosystem; to establish a network of different institutions to promote eHealth and Tele-medicine/remote healthcare/virtual healthcare and such other measures;

(b) Formulation and management of all health informatics standards for India; Laying down data management, privacy & security policies, standards and guidelines in accordance with statutory provisions; and

(c) To promote setting up of state health records repositories and health information exchanges (HIEs);

(d) To deal with privacy and confidentiality aspects of Electronic Health Records (EHR).

Functions of National eHealth Authority

(1) Core Functions

(a) Policy and Promotion

(i) Working out vision, strategy and adoption plans, with timeframes, priorities and road-map in respect of eHealth adoption by all stakeholders, both Public and Private providers, formulate policies for eHealth adoption that are best suited to Indian context and enable accelerated health outcomes in terms of access, affordability, quality and reduction in disease mortality & morbidity

(ii) To engage with stakeholders through various means so that eHealth plans are adopted and other policy, regulatory and legal provisions are implemented by both the public and private sector stakeholders.

(iii) It shall provide thought leadership, in the areas of eHealth and mHealth.

(b) Standards Development

(i) Government of India, MoHFW has published EMR/EHR standards for India in 2013. Similarly, MoHFW has become a member of IHTSDO with a view of widespread adoption of SNOMED-CT in India; MoHFW has also nominated C-DAC (Pune) as interim NRC (iNRC). As such, initial focus of NeHA would be on addressing implementation issues and promoting mechanisms in support of the same.

(ii) Concurrently, NeHA will be nurtured to undertake the role of a standards development, maintenance and support agency in the area of Health Informatics

(c) Legal Aspects including Regulation

(i) NeHA will be setup through an appropriate legislation (Act of Parliament). It is also proposed to address the issues relating to privacy and confidentiality of Patients’ EHR in the legislation. NeHA may act as an enforcement agency with suitable mandate and powers.

(ii) NeHA will be responsible for enforcement of standards and ensuring security, confidentiality and privacy of patient’s health information and records.

(d) Setting up and Maintaining Health Repositories, Electronic Health Exchanges and National Health Information Network

NeHA, while avoiding the implementation role by itself, will prepare documents relating to architecture, standards, policies and guidelines for e-Health stores, HIEs and NHIN; it may also initiate or encourage PoCs, in close consultation with government – centre and states, industry, implementers and users. Later, it would lay down operational guidelines and protocols, policies for sharing and exchange of data, audit guidelines and the like; these shall be guided by experience in operation and use of PoC, global best practices and consultations with stakeholders (MoHFW, State governments and other public and private providers, academia, R&D labs, and others).

(e) Capacity Building

Spreading awareness on Health Informatics / eHealth to healthcare delivery professionals through various educational initiatives and flexible courses according to the background of the learners will form a component of NeHA activities, as it is seen as critical to acceleration of adoption of eHealth.

(f) Other functions may be assigned to NeHA as the situation warrants.

Health being a state subject in India and much depends on the ability /regulatory framework enacted by the State governments, NeHA shall be created through legislation (Act of Parliament) that empowers it to take leadership and strategic role for setting directions for public and private eHealth initiatives, including electronic health records storage and health information exchange capabilities and other related health information technology efforts and regulation of the same.

NeHA shall ensure ongoing interagency cooperation – while engaging with various stakeholders through the Standing Consultative Committee and also through other means, in a structured, open and transparent manner to support successful evolution of national integrated health information system. We at Perry4Law Organisation (P4LO) welcome this initiative of Indian government and wish all the best to it in this regard.

E-Health Laws And Regulations In India Are Must For Successful Digital India Implementation

Healthcare is a priority aspect for governments across the world. However, despite the urgency for an effective healthcare system, timely and cost effective healthcare services are not readily available. This is more so in developing nations where healthcare services are very poor and are available to selective few only.

There are many facets of technology driven healthcare industry in India. These include online pharmacies, telemedicine, e-health, m-health, etc. India is yet to start working on these aspects on the fronts of technology and legal frameworks. We have no dedicated online pharmacy, telemedicine, e-health, m-health, data protection (pdf), privacy and other related techno legal framework in India as on date.

However, some positive steps have been taken by successive governments in India. For instance, the Electronic Health Record (EHR) Standards of India have been prescribed and establishment of a National E-Health Authority (NeHA) of India has also been proposed. Further, if we remove the shortcomings of Digital India project then the same can be used for e-health purposes as well. Digital India is presently suffering from lack of cyber security and absence of civil liberties protection in India. Another limitation of Digital India that it inherited from its predecessor National e-Governance Plan (NeGP) is absence of mandatory e-delivery of services in India. As on date there is no mandatory obligation to provide e-delivery of services in India and this is sufficient to avoid the same.

It has been reported that the health ministry of India has worked out a detailed e-health project under digital India initiative of the government. The project would include hospital information system, electronic health record facilitated with health information exchange, online delivery of services, citizen portal, online monitoring systems for services and others. The health ministry is also developing a digital platform – Integrated Health Information Platform (IHIP) – to enable creation of inter-operable health record which can be made available and accessible nationwide.

Perry4Law Organisation (P4LO) welcomes this initiative of health ministry. However, we also strongly recommend that a techno legal regulatory framework must be urgently formulated by Indian government to manage the complicated issues of Indian cyberspace and Digital India. We also recommend that telemedicine and online pharmacy laws must be complied with by the businesses and entrepreneurs of India that are ignored presently. Similarly, legal issues of cloud computing in India must also be kept in mind by e-health service providers of India. We hope these issues would be considered by Indian government while formulating an e-health related law in India.

Source: Virtual Law Campus (VLC).