INTRODUCTION

Telemedicine is a broad term that inculcates the process of remote diagnosis and medication of patients through innovation and technological means, from distant locations. It is transforming the way, how the conventional healthcare system looks like and is proved as a helping hand in overcoming the issue of lack of infrastructure in public healthcare. The great assistance of cutting-edge innovations with soaring connectivity, augmented the delivery of Medicare facilities & made them accessible to an escalating multitude of citizens.

In the term "Telemedicine," "Tele" stands for "distance" whereas "mederi" stands for "curing." Furthermore, the concept of telemedicine has also been explained by the World Health Organization (WHO) as –

"The delivery of healthcare services, where distance is a critical factor, by all healthcare professionals using information and communication technologies for the exchange of valid information for diagnosis, treatment, and prevention of disease and injuries, research and evaluation, and for the continuing education of healthcare providers, all in the interests of advancing the health of individuals and their communities."

ROLE OF COVID-19 PANDEMIC

Initially the concept of telemedicine was regarded as "utopian" but it is now a reality. Netizens endorse the application of telemedicine services during the Covid-19 Pandemic, because at that time it was riskier to interact physically, and apparently, this helped in the adoption of telehealth services by the public at large. Moreover, due to the adoption of tele-health care services such as consultation via chat, video calls, etc., patients' physical appointments to the doctor's clinic have been minimized drastically. These services thereby significantly minimize medication bills and ultimately avoid the risk to the life of both the patient and the medico.

NECESSITY AND ADVANTAGES OF TELEMEDICINE SERVICES

It has been observed all around the globe, that it is frequently challenging for inhabitants of distant and isolated locales to get a prompt, high-quality healthcare treatment due to which each year there are numerous of deaths reported. Inhabitants of these locales are often exposed to harsh and adverse climatic conditions with lack of primary healthcare facilities or having access to sub-standard healthcare facilities due to concentration of physicians in areas with urban population density.

As a result of technological advancements, Telemedicine offers the ability to reduce this gap and improve access to medical treatment in these impoverished regions. Hence, in today's world Telemedicine has emerged as a practical choice of healthcare for numerous people because it is easily available and the treatment is fairly priced.

Through Med-Tech Companies and websites – Medicare practitioners, can now work remotely with patients, which speeds up access to medical decisions and can now quickly get to another opinion for patients who have serious health issues. Additionally, doctors can also share multi-dimensional experiences with their international counterpart, and provide virtual workshops for Medicare professionals from one corner of the globe to another with respect to medical treatment, community healthcare and in educational-research.

These services, further facilitates in evidently downsizing the rate of re-hospitalization as it encourages the strict adherence by patients to their prescribed treatment and medication schedules.

Healthcare education, and workshops in general are being significantly transformed by the employment of telemedicine technology. Due to advancement in technology, research work and thesis of prominent medical experts, practitioners, quantitative data, and statistics, as obtained by various National and International Public Healthcare Institutions including National Institute of Health (NIH), National health Mission (NHM), Institute of Health Metrics and Evaluation, World Health Organisation etc. can easily be availed by the Healthcare institutions and treatment facilities.

It is crucial for the doctors to analyse the complete medical records of the patients' before initiating any further treatment, but maintaining, presenting, and analysing physical copies of all medical records, such as medical reports, past consultations, and medications is way too difficult for the patients as well as for doctors. Electronic personal health record system that is a part of telemedicine services, assist in making the experience hassle-free and now both patients and doctors can avail all the medical reports at the convenience of their smartphone or web browser. This helps patient to organise their medical records and to securely store them. Further, this also helps patients to keep track of their calories, sugar count and blood pressure. Therefore, Telemedicine services form an integrated medication ecosystem, as it facilitates medical practitioners to access records, insurance policy, the claim form, and send all data with the associated drug dispensaries. There are various popular telemedicine applications that are providing their services in India such as Practo, Lybrate, 1mg etc.

Hence, Telemedicine is not just about replacing doctors with technology, it's about empowering both doctors and patients with better access to healthcare."

IMPLEMENTATION OF TELEMEDICINE SERVICES

  • PRESENT STATUS:

With the deep penetration of 5G internet service and smartphones even to the most backward areas of India, Telemedicine services can be used to enhance the efficiency and accessibility of medical treatment. Consequent to its quick & convenient attributes, it helps in standardisation, optimisation, and simplification of the operations of healthcare centres and medical institutions. The technology has made the whole process more efficient and time-saving by facilitating services such as scheduling regular appointments, consultation visits, managing the dates for surgeries and operations, sending a reminder to patients for clinic visits, among others.

Therefore, in the Internet of Things (IoT) era, ultrafast connectivity allows to connect with and procure international technology from all over the world, for the purpose of providing a wide range of medical devices and equipment to enable higher-quality treatment.

Today, it is adequate to say that this innovative technology had resulted in a confidence vote of public at large and it is well said that, "Telemedicine is not just a trend, it's the future of public healthcare."

INVESTMENT AVENUES IN INDIAN TELEMEDICINE SECTOR

In 2019, the telemedicine market in India was estimated around USD 830 million. It is expected to develop at a compound annual growth rate (CAGR) of 31% between 2020 and 2025, outpacing the CAGR of the whole Indian healthcare industry, which is 22%.

I. Foreign Direct Investment

India's FDI regulation has recently been significantly liberalised. FDI is now authorised up to 100% through the automatic route in the hospital sector and medical device manufacturing. Under the automatic approach, FDI in the pharmaceutical sector is authorised up to 100% in greenfield projects and 74% in brownfield projects. Beyond 74% FDI in brownfield projects requires Foreign Investment Promotion Board authorisation.

II. Benefits on Taxation

In India there is a 250% deduction on the approved expenditure incurred on operating technology enables healthcare services such as telemedicine and remote radiology and further, there is an income tax exemption for 15 years for domestically manufactured medical technology products.

LEGALLANDS LLP have experience and skill set to help the client with the compliances of Foreign as well as domestic Investments including gathering requisite licenses & permits, international taxation, and financial structuring.

THE HINDRANCES IN ROBUST IMPLEMENTATION OF TELEMEDICINE

There are a few hurdles that prevented the widespread usage of telehealth treatment services, induced by dearth of tele-health. These hurdles can be classified into Legal Hurdles and Infrastructural Hurdles.

  • LEGAL HURDLES:

In India, there are a variety of statutory and regulatory bottlenecks that hampers the wide scale implementation and application of Telemedicine services, such as:

I. Absence of Robust Legislative Framework:

Presently, India is lacking an adequate, inclusive, and robust legislative and regulatory framework which would assist in determining the role, powers and duties of all intermediaries and establishment of a supervisory authority which also prepare guidelines for the telemedicine practitioners, their registration, and their functioning.

Existing regulations are either scattered and inconsistent, or obsolete, which fails to meet the issues specific to telemedicine services in India. Existing regulations include:

  1. Telemedicine Practice Guidelines 2020
  2. Drug & Cosmetics Act, 1940
  3. The Indian Medical Council Act, 1956
  4. The Indian Medical Council Regulations, 2002
  5. The Clinical Establishment (Registration and Regulation) Act, 2010
  6. Information Technology Act, 2000
  7. Consumer Protection Act, 1986

As Telemedicine services are considered as the future of healthcare sector, India needs a legislation that is consolidated yet simple and robust, that not only address the current challenges but also have the scope for accommodating future changes and addressing future challenges.

II. Data Protection Challenges:

While availing the Telemedicine services, a patient has to share a variety of data through online medium, ranging from basic details like, age, gender, weight, and height to specific details like, medical history, lifestyle habits etc. which is of sensitive nature, and one can use this data to exploit commercial avenues by targeting potential patients.

Lack of a proper data protection infrastructure and legal framework in the context of telemedicine, poses high risk of data security breach.

III. Challenges Regarding Technology Transfer & Foreign Collaboration

A variety of statutory and regulatory challenges that might occur while transferring telemedicine technology from abroad to India or vice versa, or while forming any international alliance or collaboration for the development and commercial operations of telemedicine services. Following are some examples:

  1. International Property Rights (IPR): Transfer or exchange of IPR is a critical component of a Technology Transfer Agreement (TTA) and successful transfer of IPR and its correct documentation is must for execution of TTA. For this purpose, it is significant to get the consultation of legal counsel as well as legislation that regulates IPR in India are very complicated and can be difficult to understand.
  2. Competition Laws:There are high possibility of arising of competition law challenges during the process of Technology transfer and it is an essential part of any Technology Transfer Agreement to comply with Competition Commission guidelines and to avoid any anti-competitive practises and violation of competition laws.
  3. Foreign Exchange Regulations: Exchange of Foreign currencies is generally associated with the transaction of transfer of technology, which attracts Foreign Exchange Management Act 1999 and guidelines of Reserve Bank of India (RBI). Hence, it is crucial to comply with the above-mentioned legislation and guidelines, otherwise there are penal provisions where fine may extend up to three times of the total amount involved in the transaction or/and an imprisonment term that may extend up to 7 years.
  4. Taxation: The taxation structure of India is very volatile and complicated in nature. The Technology Transfer Transaction must have tax implications and hence seeking legal advice is a no-brainer to ensure the compliance of Indian taxation regime as well as availing benefits of tax incentives.

There is a range of additional elements which must be taken into account while entering into a Technology Transfer Transaction. These consist of:

  1. Nature of the technology

Rules and regulations regarding different types of technology is different. For example, execution of a TTA of an IT technology is much easier as compared to execution of TTA of defence or nuclear technology.

  1. Purpose of the transfer

The purpose of TTA must be bonafide in nature and should not be against public interest.

  1. Parties to the transfer

TTA must be avoided with those parties that are expressly or impliedly restricted to deal in India by the government.

Consultation of a legal counsel is crucial in the process of transfer of technology in India to ensure the proper legislative and regulatory compliance and execution of TTA. This may further avoid the chances of arising of a legal issue in the future regarding the Technology Transfer.

LEGALLANDS LLP have experience and skill set to help the client with the compliances of Transfer of technology from anywhere in the world to India including gathering requisite licenses & permits, international taxation, and financial structuring.

  • INFRASTRUCTURAL HURDLES

I. NETWORK ISSUES:

Considering the widespread deployment of 5G internet services, it was anticipated that this will facilitate telehealth due to significantly speedier data transmission speeds, but it has been observed that many outlying areas, which were more likely to be benefited from the Tele-health services, lack broadband connectivity.

II. USER INTERFACE ISSUES:

Another significant issue is the paucity of convenient and adaptive telehealth user interface and inadequate concentration of technological awareness among users. In the recent years, Broadband connectivity has improved significantly all around the globe, but developing and under-developed nations lack far behind in broadband connectivity and its adoption as compared to the developed nations. Medical professionals, developers, and programmers must work together to develop telemedicine platforms while considering the requirements and concerns of the intended audience.

III. AWARENESS ISSUES

Furthermore, Education related to telemedicine is necessary for medical practitioners, specifically in their initial days when they are still medical students. And due to the characteristic of telemedicine services, patient's conventional as well as digital literacy, can also present a challenge.

TELEMEDICINE SERVICES AND A STEP FORWARD

By all counts and proven results, it can be concluded that telehealth services can substantially transform the Indian Public healthcare system by enabling hundreds of millions of residents to obtain high-quality treatment. And even though certain constraints are to be addressed, telehealth services have numerous advantages, and with proper strategy, coordination, and funding, Telehealth services will play a significant role in the development of India's healthcare system.

But for the further enhancement and development of telehealth services, we should focus on the following aspects:

I. There is an emergent requirement by healthcare institutions as well as medical practitioners, of an online payment mechanism and a record administration service.

II. In order to provide precise treatments with intensive care, medical practitioners have to employ automation and robotics that forms a part of telemedicine services. Healthcare institutions must adopt a modern approach for management of operations of institution by creating state of the art IT solutions facility. Nevertheless, such innovations only serve to support healthcare management and delivery system

III. If telehealth technologies are integrated with Artificial Intelligence (AI), they can become much more successful since they can streamline routine operations via lessening workloads of medical practitioners.

IV. The telemedicine technologies have evolved drastically and become more comprehensive and engaging due to introduction of virtual reality (VR). It has been observed that, while conducting surgeries in VR, surgeons and their colleagues get better understanding and stimulation with the help of 3D monitor.

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