National Digital Health Blueprint 2020 needs a review?

With an aim to fix the ailing healthcare facility of the country, Indian government (like other sectors – Finance, Public Distribution System etc.) has opted for digitization as a solution. In January, 2020, the government released a National Digital Health Blueprint which sets out a comprehensive framework for “Federated National Health Information System”. In March, soon enough the COVID-19 pandemic struck the country and underlined the importance of having the National Digital Health Blueprint in action. However, the pandemic situation has also highlighted the many areas of improvement for the Blueprint and the need for urgent action on such improvements. This blog post will put forth the author’s views on the need of studying the Blueprint again and including the concepts like digital therapeutics, digital diagnostics and telemedicine in its scope. The blogpost will also aim to present a picture of the diverse elements of a futuristic digital health ecosystem for India and the role that science, scientists and technology can play in establishing such an ecosystem.

Introduction

It seems like that Indian government has developed a formidable belief that technology is solution for all the deep-seated problems which are haunting the country’s socio-economic growth since independence. In 2015, the ambitious Modi government launched the “Digital India” programme with an aim to transform India into a knowledge economy, empowered with on-the-go access to information, governance and essential services. This ambition quickly received a reinforcement in the form of JIO’s success, which resulted in increasing the smartphone penetration rate and making India the second-fastest digital adopter in the world. Around the same time, the image of India’s healthcare remained pitiful and harrowing. In the Healthcare Access and Quality (HAQ) Index, India ranked below what can be considered as dismal position – 145th out of 195 countries.

India significantly lacks in implementing most of the World Health Organisation’s (WHO) recommendations regarding the adequacy in terms of doctors, nurses, medical technicians and healthcare facilities as required to cater the population. Owing to such inefficiencies, the country’s healthcare policy has been inconsistent such that India is overburdened with the task of eradicating infectious tuberculosis disease. It is only in this decade that India was able to get the polio-free status for itself. Our country is also facing exponential rise in cases of lifestyle disorders ensuing the endemic of diseases like diabetes and clinical depression. Simply put, these statistics are omen for India as a contender to be in the league of top three fastest growing economies of the world. The government of India itself has noted that in order to realize the real growth potential, the country has to fix the health systems on priority basis by investing adequate finance and manpower. Presently, Indian labor workforce is performing far below its optimum productivity due to many ill-health issues.

Therefore, the government, considering the nation’s emerging forte in digital space, has decided to go digital in healthcare reforms as well in order to analyse the consumption of health services by the population. As per the GoI, the future is technology, and India cannot accomplish its goal of ‘Health for All’ in the absence of digitization of health infrastructure and delivery. India is seeing Artificial Intelligence or Machine Learning as the foundation of accessible, affordable and quality health solutions at the intersection of technologies like biotechnology, robotics and computer science. The digital approaches for upgrading the conventional healthcare infrastructure could definitely be an antidote for the frail healthcare infrastructure given the nation’s population  is increasingly on-boarding various digital platforms. It can also be a great overall strategic direction for India to shape its influence in terms of policy-making in the context of global health. It is indeed a possibility given India’s competitive position in technology innovations and the fact that health-tech market is in a nascent stage, with all the countries almost on level playing field.   

The National Digital Health Blueprint 2020 (NDHB)

The ruling government is envisioning the digital health infrastructure as a system that will fit well or accurately with its larger aim to modernize (specifically ‘digitize’) the public health welfare system. In this line, the missions that have been already initiated by government are Ayushman Bharat, Swachh Bharat, Digital India, and Make in India.

The Ministry of Health and Family Welfare of India (MoHFW), pursuant to its afore-mentioned digital health policy initiatives, released NDHB in January 2020. This is the only detailed official explanation of PM Modi’s proposed National Digital Health Mission. It provides a picture of the entire framework of a “Federated National Health Information System”. It elaborates that the envisioned framework will inter-link systems of private and public health provider organisations serving across primary-, secondary- and tertiary-healthcare services. As the blueprint specifies, this is clearly in alignment with one of the objectives envisaged under the National Health Policy of 2017 i.e., to create an integrated health information system for all stakeholders in the health system, to improve efficiency, transparency and citizen experience.

The NDHB is indeed a well drafted document as it comprehensively shows the way the reformers have to tread in order to carry out the colossal task of developing an extensive database of electronic health records, which will be available as single source repository of health data per unique patient within India. Beyond this, state-wise datasets containing information of health-workers (doctors, nurses, paramedics) and health facilities, disease registries, inventories, and insurance claim records will also form the essential element in federated system. The blueprint provides that the database hub and key facilities will be hosted by the Health-Cloud (H-Cloud). Similar to the Aarogya Setu’s API release, the federated system will also be interoperable to allow seamless data exchange.

The blueprint obviously lists the standards for maintaining the privacy and security of the digitized health data (The next blogpost on the National Digital Health Mission will exhaustively deal with privacy and security related aspects – we also have interesting classified updates for you in that post). Project implementation will not be gradual or stage-wise, but it will follow the scheme of technology sandbox to test and roll-out the massive data-management infrastructure. The infrastructure will be further used for tracing the real-time stats related to population-wide health status. The customized and timely interventions will be made if the predictive analytics of the stats forecast community outbreaks or disease spread propensity by region. The running algorithms will be deployed to optimize data analysis and allocate scarce resources at district and state level, and more.

It has to be kept in mind, and can be inferred from the blueprint, that there are three prerequisites for successfully initiating the exercise that the NDHB proposes:

Uniform internet and telecommunications availability across the country;

An extensive network of primary healthcare centres for service delivery; and

Trained health workforce.

Presently, all these three are work in progress in India wherein Second and Third points really require a special focus.  Internet penetration in India has picked up a good rate but healthcare on field is definitely lacking. The government has to create a solid foundation through uninterrupted support, spirit and funding.

The envisioned integrated national-health data hub will be a vital asset to run process and analyze all the complex health data, which can be leveraged for creating accurate policy-designs and well-gripped implementation control. For example, through algorithms, timely automated intervention within the health system will increase cooperation. As soon as certain stat will touch a determined threshold, the notifications will trigger the appropriate health-crisis management authorities. The entire process will include relaying of targeted messages within the population, automated stock and inventory management warnings, and virtual medical training and research, to create a strong foundation for affordable and efficient healthcare. Once operational, the database is expected to connect and expedite India’s slow-moving fragmented health system. While this will not immediately fix the system entirely, it is surely a step towards making it efficient and future-ready.

Is everything right with the Blueprint?

The Blueprint definitely mentions about the great plan of futuristic healthcare infrastructure. However, it is still far from being an “all-encompassing vision document” which is needed to provide solution to two-fold issues: (a) A launch pad for India’s digital health ambition, and (b) Need of resolving the deeply entrenched issues with healthcare that persist for years now. Therefore, it is needed to trace specific to context use cases recognizing the problems that are unique to India.

Even the WHO’s guidance has made the point that digital-health interventions must be treated as supplements, not substitutes, for functioning health systems. The Blueprint requires major upgrades to its dimensions- which means priority push for digital policy on therapeutics, diagnostics and medicine.

Policy action needed to reform therapeutics and diagnostics in India must be aligned with the broader AI policy of India. The current version of India’s AI policy provides “healthcare” as one of the most promising areas but admits the obstacles it will face in creating a new path. India is not alone in this predicament. Recognizing best practices around the world and picking out unique use-cases, the following points must be considered to strengthen the policy in terms of therapeutics and diagnostics:

1. Promoting indigenous innovation in health-tech while maintaining technological sovereignty;

2. The use-cases with respect to healthcare must be selected keeping in mind the inherent infrastructure limitations and resource shortages;

3. While going digital, it is important to keep patient safety as priority through adopting regulatory frameworks that mandate scientific and clinical validation of products/services;

4. One thing that is essential to the traditional doctor-patient relationship is trust. The approach must invest in creating a reliable infrastructure.

5. Real-world transparency, data confidentiality, cyber security and ethics should be the foundational principles when an innovator envisages a health-tech innovation. Proper guidelines for medical software developers and policy on transparent data-sharing agreements wherein, rights of patients are protected must be rolled out at the earliest.

Conclusion

Therefore, it is important to say it again, the Digital Health is not the immediate relief given the limitations of the India’s healthcare, i.e. inadequate infrastructure and resource shortages. However, one thing we have learnt for sure is that a better-connected and digitized nation is better-prepared to achieve sustainable development goals if policy’s approach is inclusive in real sense, and to face unprecedented black swans of magnitude like Covid-19 pandemic. Digital health adoption will bring many changes in the functioning of the current system across the value chain. The benefits of public goods, products and services under this category must be maximized, with minimum disruption to the society. If all goes well i.e. policy implemented properly and limitations checked promptly, the NDHB could be a chance for India to get rid of its ailing healthcare infrastructure.

(These are personal views and opinions of the author and do not necessarily reflect views of any organisation)

Let us talk about E-Contracts (II): E-Commerce Business Models

Without any argument, new communication systems, especially digital payment technologies, have supplanted the snail-paced conventional systems of communication and transactions. Business communities and consumers are increasingly using digital means to send and receive information in electronic form. The reason is that the information technology (IT) has abridged the time and distance factor in transacting business. Nowadays, inflow and outflow of information have become instant and momentary. Therefore, one principal contribution of IT is in the field of contract-formation.

Electronic contracts (e-contracts) are born out of the need for speed, convenience and effectiveness. The law has already recognised contract-formation using facsimile, telex and other similar technologies.

Let us envision a contract between an Indian businessman and an English businessman. Away from digital means, one option is that one party first draws up two copies of the contract, signs them and sends (through postal or courier service) them to the other, who, in turn, signs both copies and sends one copy back. The other option would be that the two parties meet somewhere and sign the contract. However, within the digital world, the whole process can be completed in seconds, with both parties simply affixing their electronic signatures to the electronic copy of their contract. There is, thus, no need for tardy dispatching mechanism (postal or courier services) and/or supplementary travelling costs in such a situation.

Before proceeding with the E-Contracts, let us have a brief look at the basics of the business model and kinds of transactions under which e-contracts are mostly used.

E-Commerce Business Models

Electronic commerce (e-commerce), in a very general sense, refers to buying and selling products and services over the internet and the World Wide Web (www). E-commerce, however, in actuality, includes all forms of commercial transactions involving both—organisations and individuals—that are based upon the electronic processing and transmission of data including text, sound, and visual images; and involves transactions over the internet as well. In addition, e-commerce also refers to the effect that the electronic exchange of commercial information may have on the institutions and processes that support and govern commercial activities.

There are several ways of looking at e-commerce:

(1) From a communications perspective, it is the ability to deliver products, services, information, or payments via networks like the internet.

(2) From an interface view, it means information and transaction exchanges: business-to-business (B2B), business-to-consumer (B2C), consumer-to-consumer (C2C), and business-to-government (B2G).

(3) As a business process, e-commerce means activities that support commerce electronically by networked connections. For example, business processes like manufacturing and inventory and business-to-business processes, like supply chain management is managed by the same networks as business-to-consumer processes.

(4) From an online perspective, e-commerce is an electronic environment that allows sellers to buy and sell products, services, and information on the internet. The products may be physical, like cars; or services, like news or consulting, etc.

(5) As a structure, e-commerce deals with various media: data, text, web pages, internet telephony, and internet desktop video.

(6) As a market, e-commerce is a worldwide network. A local store can open a web storefront and find the world at its doorstep—customers, suppliers, competitors, and payment services. Of course, an advertising presence is essential.

Types of Online Transaction

Online transactions can be recognised and categorised in four ways:

Business to Customer (B2C)

It is the transaction where a business entity on one side and an individual customer, on the other hand, conduct business. The expression B2C has been commonly used to refer to a sale by a business enterprise or retailer to a person or ‘consumer’ conducted through the internet. For instance, Flipkart.com which provides facilities for customers to buy goods from the website—is an example of a B2C e-business. In this situation, the website itself serves the purpose of a shop. The B2C transactions can be in relation to both—tangible and intangible products. The focal point of this e-commerce application is on the consumer’s use of a merchant’s web storefront or website. Consumers from any place can browse and order for goods and services online at any time. B2C is an electronic equivalent of the conventional mail-order or telephone-based ordering system.

Business to Business (B2B)

It is the type of e-commerce where there is an exchange of products, services, or information between businesses using the internet, rather than between businesses and consumers. Alibaba.com is the prominent example of B2B model.

Customer to Business (C2B)

Customer to Business (C2B), also known as Consumer to Business, is the most recent e-commerce business model, where individual customers offer to sell products and services to companies that are prepared to purchase them. It is the opposite of the traditional B2C model. Example of this model is blogs or internet forums where the author offers a link back to an online business facilitating the purchase of some product (like a book on Amazon.com), and the author might receive affiliate revenue from a successful sale.

Customer to Customer (C2C)

It is the transaction which involves two or more customers with business entity merely providing a web-based interface to facilitate the consumer to consumer transactions (B2C). The expression C2C generally refers to the sale of a product pertaining to a consumer to another consumer either directly or through an intermediary exclusively dedicated for this activity. One best example of C2C website is Ebay.com, which is an online auction site, where any person can buy and sell, and exchange goods and articles using this website. This website provides the web-based interface (i.e. the website with its database and other functions) and users can transact freely with each other. Another example is Amazon, which in fact, acts as both a B2C and a C2C marketplace.

Recommended Readings

  • Alan Davidson, The Law of Electronic Commerce, Cambridge University Press, (2009).
  • R K Singh, Law Relating To Electronic Contracts (2017)

Simplifying FinTech and FinTech Laws: Regulatory Initiatives taken by Government and Regulators in India for FinTech

No industry in the economy can boom unless it is supported by the Government in the country it wishes to further expand in. A fine line exists between regulation and obstacles for the industry to boom. In light of this, the Government of India has begun to take initiatives and steps toward the stronger building of fintech in the country, paving the path for this industry to a brighter future. This post will give you a brief overview of all the regulatory initiatives that the Government and Regulators have taken to promote the FinTech in India. This is the fourth post in the series of ‘Simplifying FinTech and FinTech Laws’.

Fintech in the past decade has expanded rapidly. What once emerged as merely as an intersection point of financial services and technology, has now become an important aspect of India’s economy. With the vision of the country towards a digitized and less dependent economy with ‘make in India’, fintech has gained a larger space to expand in and function smoothly. According to the NASSCOM Report ‘Fintech Landing- Unlocking Untapped Potential’, it is because of initiatives in India that have led India to emerge as a leader for the fintech industry worldwide. According to this research by NASSCOM, India alone harbours 2% of the largest start-up base for fintech in the world and also leads in the rate of adoption of fintech at 87% adoption rate.

Not only the initiatives by the Government adversely affect the success of the fintech industry in the country, but the allied regulators of financial institutions play a role as well. These include regulators such as SEBI, RBI, Insurance Sector, etc. Such an encouraging atmosphere for the development of fintech in the country has increased faith in fintech among the consumers in the country, for easier and grass-root adoption and acceptance of fintech.

Initiatives by the Central Government

Encouragement for the Start-Ups

With the policies such as that of make in India and to boost the Indian economy, the start-ups are increasingly supported by the Government. In 2015 itself, over 12,000 start-ups in the area of fintech emerged across the world. In India, the initiative to support the start-ups was launched by the Central Government in 2016, reserving USD 1.5 billion funds to support the start-ups. Under the increased support, he start-ups began to receive in the country, there are more than 600 startups in fintech at present in India. It is in light of such an initiative begun by the Government and supported by the allied stakeholders that India progresses towards the vision of a completely digitalised economy, promoted innovation and leading economy with sustainable growth.
In further aid of this initiative that the Government has now introduced tax reliefs such as 3-year exemption from paying tax for the start-ups along with other exemptions, credit guarantee, etc.

Digitization of the Economy

The current Government fiercely promotes the digitization of the economy. Whether intended or not, the unprecedented demonetization has acted nothing less than a catalyst in increasing the digital payments in the country. Having scaled the benefits of digital payments, it is now increasingly used by the country than retreating back to the physical currency. Such an environment is an ideal environment for the fintech ecosystem to thrive in.

Taxation Reliefs

Apart from the policies of the Government to support the fintech, taxing regime plays a major role in the growth of the fintech industry in the country. The 2016 Budget introduced tax rebates for those traders who transacted more than 50% of their bill digitally. The Ministry of Finance further proposed withdrawal of surcharge on digital payments of cards and online used to avail government services. The surcharges as of now stay relaxed.

Protection of Intellectual Property

The fintech start-ups are supported with ease in the procurement of intellectual property (IP) acquirement. The facilitation in the acquirement of trademarks, patents, designs, etc. has led to an increase in the start-ups under the fintech industry in the country. Moreover, under the start-ups initiative, the Government offers 80% rebates for the patent costs required for the start-ups.

Infrastructural Plans

The Government’s plans to accelerate the economy of the country with digital India and Smart Cities have led to an increase in reliance upon fintech in the country more than ever. Not only the local fintech industry is expected to benefit out of his but the outsourcing and foreign investment are also expected to be increased to further the advancement of the fintech industry in the country.

National Payments Council of India

It is the umbrella organisation for all retail payments in India, under the guidance of RBI and Indian Banks Association. With the increase of multiple usages of mobiles in India and increased acceptance of Unified Payment Interface (UPI), there was a paved way for the National Payments Council in India (NPCI). The expected userbase of smartphones is by 2020 is 500 million. Thus, the digital footprint is expected to rise as well. Initiatives by the NPCI such as that of Rupay Cards have led to fintech adopting such technologies, penetrating further into the traditional banking system in the country.

India Stack

India Stack is a set of Application Program Interfaces that allow entities such as businesses, start-ups, governments and developers to engage in the utilisation of the digital infrastructure. This unique feature of India Stack helps to solve problems in ground level in India and promote the paperless, cashless and presence-less delivery system in India. India Stack mirrors the support system offered to the telecom industry back in the 1990s for the fintech industry in the country. This has enabled the manifold increase in fintech in the country and has facilitated easy adoption of fintech by the innovators, entrepreneurs, other industries and companies. However, after the Aadhaar judgment, the India Stack programme has stopped.

Initiatives by Financial Market Regulators

The financial market regulators (FMRs) role has gravely impacted the fate of the fintech industry in the country. Some of the primary FMRs are discussed herein:

Reserve Bank of India (RBI)

One of the most recent initiative by RBI for the adoption of fintech in the financial market is allowance to set up the regulatory sandbox. This refers to the controlled environment in which live testing of digitally innovative techniques may be conducted in the arenas of e-KYC, retail payments, management of wealth, etc. RBI has also acknowledged the possibility of fintech disruptions in the financial market, in light of which certain regulatory norms have been introduced. However, it is to be noted that these are purely regulatory in nature in benefit of the consumers and fintech industries, without creating a hurdle for the boom of the fintech industry. Moreover, to better understand the nitty-gritty of fintech in influencing the traditional financial market, RBI set up an inter regulatory working group to come up with an appropriate framework for fintech without disrupting its functions. RBI in 2017 released a ‘Report on Working Group on Fintech and Digital Banking’ acknowledging fintech to be a point of attention in today’s era and uncertain regulatory regime to stunt its growth. Thus, RBI persuades other sectors to be better apprised with fintech to come up with better and definable regulatory regime so as to not cause unprecedented or unforeseen loss to this industry and continue with its growth.

However, with no uniform set of guidelines and no particular authority to govern fintech, fintech at present faces loss in this area. The aforementioned market regulators have their own policies for fintech which often overlap and defeat the purpose of facilitating policies to obstacles fintech needs to overpower to ensure its smooth functioning. The grey areas of fintech require to be urgently addressed so that the booming growth does not reduce to stunted growth of the industry India expected to lead in future. It is expected with RBI’s report and acknowledged lacuna in the current fintech ecosystem, changes are soon to begun to take place across all sectors in the financial market to ease the functioning of fintech for greater benefits.

The RBI has also introduced several small fintech spaces in order to invite comments from general stakeholders before issuing any regulation governing new technologically innovative financial products. The RBI has released a ‘Draft enabling Framework for Regulatory Sandboxes’ which proposes guidelines on governing regulatory sandboxes to be established by RBI to check on the R&D of new fintech products and services.
The RBI, as well, has recognized the need for confidentiality and data protection. The RBI’s “Master Circular on Mobile Banking Transactions in India” states that “technology used for mobile banking must be secure and should ensure confidentiality”.

Below is the table that represents how well are such fin-tech regulatory sandboxes faring. This is an independent research initiative by the author.

Country Name of the Regulator Date of Starting Sandbox Name/ Project Name Number of Participants Remarks
The United Kingdom Financial Conduct Authority (FCA) Launched in October 2014- First cohort of applications opened on May 2016 The regulatory sandbox is a part of the project called Innovate by FCA Nearly 375 Applications (Since 2016); Nearly 131 Applications have been accepted. Sources: FCA publication on’Regulatory Sandbox lesson learnt’ https://www.fca.org.uk/publication/research-and-data/regulatory-sandbox-lessons-learned-report.pdf. Also See, Official Webpage of the FCA Regulatory Sandbox, https://www.fca.org.uk/firms/regulatory-sandbox/cohort-1 Following sources have been referred to understand the framework of ‘Regulatory Sandboxes’ in the UK: 1) FCA publication on Regulatory Sandbox https://www.fca.org.uk/publication/research/regulatory-sandbox.pdf; 2) FCA publication on’Regulatory Sandbox lesson learnt’ https://www.fca.org.uk/publication/research-and-data/regulatory-sandbox-lessons-learned-report.pdf; 3) Guide to Financial and Regulatory Innovation https://assets.publishing.service.gov.uk/government/uploads/system/uploads/attachment_data/file/701847/UK_finanical___regulatory_innovation.pdf
Singapore Monetary Authority of Singapore Launched in November 2016 There are two kinds of Sandboxes that have been proposed under the MAS supervision: ‘Sandbox’ and ‘Sandbox Xpress’ Nearly 50 Formal Applications have been considered; Half were withdrawn; 1/3rd proceeded without the need of Sandbox; remaining being approved or under review. (till 2019) Source: NUS CBFL working paper 19/04 https://law.nus.edu.sg/cbfl/pdfs/working_papers/CBFL-WPS-1904.pdf The low figures of participation is because MAS is very specifically selective about the applicants and MAS’ view of Sandbox as a last resort to facilitate innovation,
with the primary tool being instituting facilitative regulations in the first place. Further readings are important: https://law.nus.edu.sg/cbfl/pdfs/working_papers/CBFL-WPS-1904.pdf; MAS gidelines on Sandbox https://www.mas.gov.sg/-/media/MAS/Smart-Financial-Centre/Sandbox/FinTech-Regulatory-Sandbox-Guidelines-19Feb2018.pdf?la=en&hash=B1D36C055AA641F580058339 09448CC19A014F7; The MAS Act https://www.mas.gov.sg/regulation/acts/mas-act
Australia Australian Securities and Investments Commission (ASIC) Launched in December, 2016 Fintech Regulatory Sandbox is a part of Project Innovation Hub by the ASIC As set out in ASIC’s Innovation Hub Progress Report as of October 2018, 314 entities requested and received informal assistance, and 67 new AFSLs/ACLs were granted. In 2018–19, the Innovation Hub provided informal assistance to over 190 businesses (fintech and regtech), helping them consider regulatory issues early and where relevant prepare licence or relief applications. Source:ASIC Cooperation Report 2017-18 https://download.asic.gov.au/media/4922434/annual-report-2017-18-published-31-october-2018-section5.pdf & ASIC Cooperation Report 2018-19 https://download.asic.gov.au/media/5314426/asic-annual-report-2018-19-section-5.pdf. The Treasury Laws Amendment (2018 Measures No. 2) Bill 2019 (Bill) could provide an example of ideal specific legislative framework related to Fintech Sandboxes given the number of benefits it proposes. The Bill aims to enhance the existing regime by enabling more businesses to test a wider range of financial products and services, for a longer period of time. The Federal Government anticipates that this will help drive competition in the financial services industry, incentivising financial providers to be more responsive to the needs of consumers. While the Bill broadens the types of credit products and services which are eligible for the regime, it simultaneously imposes stricter requirements on credit services which are already subject to the regime. Sources referred: ASIC expands Sandbox Regime https://www.lexology.com/library/detail.aspx?g=825aafdb-0cf4-4dfd-b6b0-be411bb5f957;
Malaysia Bank Negara Malaysia (BNM) through its cross-functional group the Financial Technology Enabler Group (FTEG) Launched in October 2016 Regulatory Sandbox Till October 2019, 80 applications have been submitted under the Financial Technology Regulatory Sandbox. Source: Assistant Governor Keynote Address at the Takaful Rendezvous 2019 – “Leading in a Disruptive World – Revolutionising Takaful” at https://www.bnm.gov.my/index.php?ch=en_speech&pg=en_speech&ac=841. In 2017, there have been four confirmed participants and while in 2018 , there have been six confirmed participants (in which 1 exited later). Source: The State of Regulatory Sandboxes in Developing Countries, Digital Financial Services Observatory, Columbia Institute for Teleinformation, Columbia University, New York, https://dfsobservatory.com/sites/default/files/DFSO%20-%20The%20State%20of%20Regulatory%20Sandboxes%20in%20Developing%20Countries%20-%20PUBLIC.pdf Sources to refer: 1) BNM has provided a regulatory framework for the ‘Fintech Regulatory Sandbox Framework”. http://www.bnm.gov.my/index.php?ch=57&pg=137&ac=533&bb=file; 2) Infographics explain it all, https://www.myfteg.com/?page_id=1129; 3) The State of Regulatory Sandboxes in Developing Countries, Digital Financial Services Observatory, Columbia Institute for Teleinformation, Columbia University, New York, https://dfsobservatory.com/sites/default/files/DFSO%20-%20The%20State%20of%20Regulatory%20Sandboxes%20in%20Developing%20Countries%20-%20PUBLIC.pdf; 4) FAQs related to Sandbox, https://www.myfteg.com/?page_id=1133.
Hong Kong Hong Kong Monetary Authority Launched in November, 2016 Fintech Supervisory Sandbox (FSS) Nearly 170 Tested Participants [By the end of 2017, 28 fintech products tested (HKMA Annual Report 2017, Pg109, https://www.hkma.gov.hk/media/eng/publication-and-research/annual-report/2017/AR2017E.pdf), then by 2018, 42 products have been tested (HKMA Annual Report 2018, Pg.7, https://www.hkma.gov.hk/media/eng/publication-and-research/annual-report/2018/AR2018E.pdf) and till October 2019, around 92 new technology projects have been tested (Usage of the FSS until the end of October 2019, https://www.hkma.gov.hk/eng/key-functions/international-financial-centre/fintech/fintech-supervisory-sandbox-fss/)%5D. Nearly 84 products have been rolled out in the Market successfully (14 in 2017, 28 in 2018 and 42 till October 2019) Following sources are required to be referred to: HKMA-FSS framework of guidelines, https://www.hkma.gov.hk/media/eng/doc/key-information/guidelines-and-circular/2016/20160906e1.pdf; HKMA Annual Report 2017, Pg109, https://www.hkma.gov.hk/media/eng/publication-and-research/annual-report/2017/AR2017E.pdf.
Securities and Futures Commission (SFC) September, 2017 SFC Regulatory Sandboxes In 2018, there have been 2 firms that have been tested. (Source: https://bfsi.economictimes.indiatimes.com/news/regtech/global-sandbox-by-gfin-to-boost-cross-border-innovation-in-financial-services-fintech-association-of-hong-kong/69376356) Checked all the official reports but they have not provided any explicit number. I have scheduled a call with Syed Musari, Chairman of the HK Fintech Assn. [On call also he said there are 2 only such firms that have been confirmed till now) Following Sources: ‘Circular to announce SFC Regulatory Sandbox’, https://www.sfc.hk/edistributionWeb/gateway/EN/circular/openFile?refNo=17EC63
Insurance Authority (“IA”) Launched in September, 2017 IA Insur-tech Sandbox Since the launch of Insurtech Sandbox until end February 2019, IA received eight sandbox applications and two were completed and rolled out to the market. Source: Discussion Paper, Legislative Council Panel on Financial Affairs, LC Paper No. CB(1) 70/18-19(04), Pg.6, https://www.legco.gov.hk/yr18-19/english/panels/fa/papers/fa20190401cb1-760-4-e.pdf Following sources can be referred to: 1) https://www.ia.org.hk/en/aboutus/insurtech_corner.html#1 ; 2) Discussion Paper, Legislative Council Panel on Financial Affairs, LC Paper No. CB(1) 70/18-19(04), Pg.6, https://www.legco.gov.hk/yr18-19/english/panels/fa/papers/fa20190401cb1-760-4-e.pdf
Bahrain Central Bank of Bahrain’s FinTech and Innovation Unit Launched in May 2017 The Regulatory Sandbox Since its launch in 2017, 35 Fintech participants have been included in the Sandbox. (As provided on the official website in the section of ‘Regulatory Sandbox Register’ at https://www.cbb.gov.bh/fintech/). Although, till 2018 CBB received 48 applications. (Source: CBB Annual Report, https://www.cbb.gov.bh/wp-content/uploads/2019/04/CBB-Annual-Report-2018-English-1.pdf) Following sources: 1) ‘Regulatory Sandbox Register’ at https://www.cbb.gov.bh/fintech/ ; 2) CBB Annual Report, https://www.cbb.gov.bh/wp-content/uploads/2019/04/CBB-Annual-Report-2018-English-1.pdf; 3) The Circular https://cbb.complinet.com/net_file_store/new_rulebooks/c/o/Cover_letter-Regulatory_Sandbox-Amended28Aug2017.pdf
Netherlands De Nederlandsche Bank (DNB) Aand Dutch Authority for the Financial Markets (AFM) as per their MoC (Memorandum of Cooperation) Launched in January 2017 Regulatory Sandbox’ under the Innovation Hub There is no specifc register or data that is available for the number of entities that are strictly part of the Regulatory Sandbox (Even in their guiding paper released in December 2016, they specifically stated in Section 4, at Pg.5, that “such requests are confidential and will be treated as such”.) Although, the regulators have shared that total 650 queries has been received by the Innovation Hub and Sandbox together till 28th August 2019 (Source: Report DNB-AFM, Continuing Dialogue, InnHub and RegSandbox: lessons learned after three years, https://www.dnb.nl/en/binaries/Continuing%20dialogue_tcm47-385301.pdf) Following Sources can be referred to: 1) De Brauw Blackstone Westbroek, https://www.debrauw.com/alert/dnb-afm-create-regulatory-sandbox/; 2) Guiding paper/Framework related to Regulatory Sandbox, https://www.dnb.nl/en/binaries/More-room-for-innovation-in-the-financial%20sector_tcm47-361364.pdf?2020011512; 3) Report DNB-AFM, Continuing Dialogue, InnHub and RegSandbox: lessons learned after three years, https://www.dnb.nl/en/binaries/Continuing%20dialogue_tcm47-385301.pd; 4) European Banking Authority, Report, FinTech: Regulatory sandboxes and innovation hubs, https://www.esma.europa.eu/sites/default/files/library/jc_2018_74_joint_report_on_regulatory_sandboxes_and_innovation_hubs.pdf.)
UAE Financial Services Regulatory Authority Launched in August 2016. Although, the first cohort started in May 2017 FinTech Regulatory Laboratory (RegLab) Until October 2019, 185 Applicants, 74 Participated – [First Cohort: 11 Applicants, 5 Selected (Official Press Release, https://www.adgm.com/media/announcements/abu-dhabi-global-market-admits-first-5-regional-and-international-reglab-applicants); Second Cohort: 22 Applicants, 11 Selected (Official Press Release, https://www.adgm.com/media/announcements/abu-dhabi-global-market-admits-2nd-reglab-cohort-with-11-more-local–global-fintech-firms); Third Cohort: 69 Applicants, 26 Selected (Official Press Release, https://www.adgm.com/media/announcements/abu-dhabi-global-market-admits-3rd-reglab-cohort-with-more-uae-fintech-firms); Fourth Cohort:83 Applicants, 32 Selected (Official Press Release, https://www.adgm.com/media/announcements/adgm-admits-4th-reglab-cohort)%5D. Following sources: 1) The official Guidance, The guidance paper, http://adgm.complinet.com/net_file_store/new_rulebooks/f/i/FinTech_RegLab_Guidance_VER01_31082016.pdf; 2) Entire legal framework and associated papers can be found here http://adgm.complinet.com/en/display/display_main.html?rbid=4503&element_id=13995.

Securities Exchange Board of India (SEBI)

The presence of SEBI has largely affected the financial market for over two and a half decades now. The interface of technology in the financial market has only led to a rise in the financial sector. It has led to efficiency in the system of trading, reduced costs of transactions and an increase in consumer base. Not only this, technology has played a significant role in democratising the financial market. While these remain the immediate effect felt of technology as it entered the financial market, more recent are the machine-based and algorithmic trading. SEBI has warmly welcomed technology in the market with screen-based trading, dematerialisation of shares and using it as a platform to offer nationwide trading. The capital market in India with such innovations backed by SEBI has witnessed the transformation in recent years.

Insurance Sector

The innovation in the insurance sector has always been thought about twice, such that its adoption has remained the slowest in this sector in the financial market. However, the past decade with the rise of fintech has seen the regime of insurance sector change, especially with the digital channels and process automation. Technology has further led to the addition of personal touch and customised services for consumers. The fintech had led to increasing common conscience of the society to repose faith in the insurance sector due to customised services and cost-effective functions. Fintech has ensured that the start-ups in the insurance sector do not act as a tool of disruption in the insurance sector and spread a sense of insecurity amongst the existing companies but act as a collaborator, collate the efforts of all and direct services for the benefit of the consumers.

Recommended Readings:

Solve India’s problems’: Modi launches Rs 100 billion fund, generous tax breaks for Indian start-ups, First Post, 17 January 2016, http://www.firstpost.com/business/pm-modis-grandinitiative-for-indian-start-ups-a-rs-10000-cr-fund-3-year-tax-rebate-2587272.html accessed on 25 May 2016.
Budget 2016: Start-ups get 100 per cent tax exemption for 3 years on profits, 29 February 2016, DNA India, http://www.dnaindia.com/money/report-budget-2016-start-ups-get-100-taxexemption-for-3-years-on-profits-2183981(last accessed on 25 May 2019).

Manisha Shroff, Nikita Nehriya, Ankit Chavan and Praneetha Vasan, Data Privacy: Have Banking Laws in India kept pace with Technology, Indian Law News Vol 9 Issue 2, at https://www.khaitanco.com/PublicationsDocs/IndiaLawNews-KCOcoverageManishaShroff-Copy%20(2).pdf

Balancing the Regulation and the Innovation: GDPR and AI

Artificial Intelligence (AI) sector is promising an altogether new generation of technological advancement being highly disruptive and productive for the Industry 4.0. AI is a constellation of technologies performing different cognitive functions- data analysis to language learning that assists a machine to understand thoughts, experiences and senses. The major functioning of A.I is to analyse the data and provide responses in accordance to the collected intelligence, basically AI provides a sui generis ability to analyse the big data applications in its various dimensions. Therefore, AI is most about the computer-generated behaviours which is considered intelligent in human beings. The concept of AI has existed for some time now, and contemporarily it is a reason of rapidly increasing computational power in industry (a phenomenon known as Moore’s law) [i] leading to the point where AI market will surpass $100 billion by 2025.[ii] AI is significant as it will transform the medium of interaction between humans and technology resulting in overall societal advantages such as inventiveness, innovation and confidence.

With all the advancement that AI will bring in the industry, it brings a lot of concern for regulators across the different jurisdictions. One of the major concerns with the application of AI is its character of feasting on large amount of data and hence its impact on data-privacy. This is making the regulators hesitant in order to allow AI start-ups to initiate any kind of large-scale activities based on AI technology. AI start-ups are soon going to hit a major impediment as the European Union’s General Data Protection Regulation (GDPR) is in effect now. The GDPR, adopted in April 2016, is being considered as the intention of European Union (EU) to form a strengthened, integrated and unified data-privacy mechanism within the EU. It aims primarily to provide the EU citizens an instrument of more control over their personal data and its protection. It provides a framework in which individuals will have liberty to ask questions that how the companies or institutions are processing and storing their personal data. The challenge of full accountability to consumer as strictly put mentioned by the GDPR makes the collection of data by more difficult impacting the AI start-ups which are absolutely dependant on varieties of personal data for machine-learning initiatives.

When it comes to knowing the specific limits that GDPR will put on AI start-ups and services then it can be explained in two-fold impacts. Firstly, processing of data has direct legal effects on the customer, such as credit applications, e-recruiting, or workplace monitoring, the GDPR will completely limit the usefulness of AI or these purposes as the Article 22 and Recital 71[iii] strictly provides for the requirement of explicit consent for each and every unit of data that is used making the functioning of the market slower. Secondly, the algorithms that the AI developers use for the application evolve themselves making it later not at all understandable, and this data combination becomes very complex to regulate.[iv]

The way out for AI start-ups seems to be in the organisational procedures that can standardise the obtaining of consent for the governance of the data within a well-structured data management framework. To be in compliance with the GDPR while processing the huge amount of data it is required that AI developers provide a fixed policy of filing an automated appeal to consumers. Illustrating this it is required that if a consumer is denied the service by any AI application, developers should provide a chance to know the reason to that consumer i.e. an appeal. It is worth mentioning that it is humans that have created, modified and implemented AI technology and they also have the potential to make it compliant and moderate according to the reasonable considerations of regulators. GDPR is not an evil for AI applications but it is just a regulatory initiative with which if AI technology develops, it will get more confidence of the potential consumers.

[i] ICO, Big Data, Artificial Intelligence, Machine Learning and Data Protection, Information Commissioner’s Office, https://ico.org.uk/media/for-organisations/documents/2013559/big-data-ai-ml-and-data-protection.pdf.

[ii] Todd Wright and Mary Beth, The GDPR: An Artificial Intelligence Killer?, Datanami, https://www.datanami.com/2018/02/27/gdpr-artificial-intelligence-killer/.

[iii] David Roe, Understanding GDPR and Its impact on the Development of AI, CMS wire, https://www.cmswire.com/information-management/understanding-gdpr-and-its-impact-on-the-development-of-ai/.

[iv] David Meyer, AI Has a Big Privacy Problem and Europe’s New Data Protection Law Is About to Expose It, Fortune, http://fortune.com/2018/05/25/ai-machine-learning-privacy-gdpr/.

Understanding the ‘Technology of Regulation’: Regulating the Scientific Advancements

Regulations are most often considered as adversaries of technological changes. The position of technology is to stimulate the growth of the enterprises, markets, and industries, while the periodical regulations as issued by the government, represents the limits that are imposed on this growth. This is the general conception of regulations that is no doubt everyone has regarding the regulation of technology since the 1970s when the debate started which was focused on controlling the nation-states expedition of nuclear energy, supersonic transport, and food additives. Today, the debate continues as the fears of technologies such as dark web, genetically modified foods etc. calling for regulations as precautionary measures. And to an extent, the conflict is unavoidable.

The dynamics that are induced by the technology revolution are credited with half or more productivity growth. The process of ‘creative destruction’ by entrepreneurs who devise new ways of producing goods and services is potentially a far more potent source of progress that is short-term price competition, as pointed out by Schumpeter. However, regulation can retard all of Schumpeter’s three stages of technological change: invention, innovation, and diffusion.

Every negative in the whole story is just not about the regulations. An anxiety amounts when there is talk about driverless cars, artificial intelligence, and social media, regulation is the only way to relax the stress of uncertainties that these technological changes will bring in lives of humans. These are not the views of legislators only, but also from the people who are driving these technologies and people who are driven by these technologies.

Is there a way to balance regulation and technology? The way seems to be accepting the change in the technology of regulation. Regulations are being imposed in traditional ways only such that considered to be of one type and of effecting in one way only. However, there is a way to explore more in this regard, just as there are many different types of technologies, there are many different types of regulations. Different technology instruments, such as technical requirements, performance standards, taxes, allowances, and information disclosure, can have very different effects on technological change and other important consequences.

One of the main reasons that the present regulatory technology is not rendering desired results is that the state regulators are not dedicating the time, energy, or funding to the regulations in the way the technology is developed. The key to bringing in the same creativity and inspiration into the regulations, such that the incentivized-approach must be followed, is to allow the private regulators to build the regulatory systems of the digital age.

The drivers of this shift are often ultimately regulated companies themselves- looking to define a reasonably reliable playing field on which they and their competitors meet. Private regulators are already regulating to a certain extent by having autonomy over the governance of choosing their terms and conditions of the ‘agreement’ which is the main source of the entire corporate control. Another compelling reason for bringing up the private regulators in the game is that the private entities are closer to what is happening, at increasingly high speed, on the ground, and in the cloud is not going to go away till the time they are responsible for developing new technologies.

It is very important to create a supervised cohort of private regulators. This gets the best of both worlds: the regulations that follow the incentivized approach and being accountable to the government and the understanding of these regulations to the market players in very clear terms. The question of arbitrariness because of these regulators cannot creep in as the licenses to regulate will always be in the hands of the government. Further, they have to keep their regulatory clients happy by developing easier, less costly and more flexible ways of implementing regulatory controls.

The sooner we adopt the new technology of regulation and move beyond the idea that conventional regulation can handle the challenges of our powerful new technologies, the better. The idea to regulate the innovative and disruptive technologies is a useless idea unless we figure out how to harness the power of markets, and new approaches to government accountability, to that task.

(This blog series will explore and cover all the areas of regulations that are present and required for adjusting the balance with certain scientific advancements. Suggestions and Improvements are invited from readers)