This article has been written by Ms. AGRATA CHATURVEDI, a 1ST year student of LLOYD LAW COLLEGE, GREATER NOIDA.

Abstract

Innovations in digital health are revolutionizing the healthcare industry by providing fresh approaches to better patient outcomes, expedite the delivery of care, and increase overall effectiveness. Examining the relationship between innovation and intellectual property rights (IPR) protection is essential as digital health projects proliferate in India. This article explores the state of digital health technologies in India, looks at IPR protection issues, and suggests ways to create an atmosphere that is supportive of long-term innovation.

Introduction

The convergence of technology and healthcare has given birth to digital health innovations that include a wide range of solutions such as telemedicine, health information systems, mobile devices and artificial intelligence in diagnostics. With its growing population and increasing healthcare services, India is at the forefront of this digital healthcare revolution. However, the success and sustainability of these innovations depends on strong protection of intellectual property. The World Health Organization defines the concept of digital health as andquot; a broad umbrella term that includes eHealth as well as emerging areas such as the use of advanced IT. in big data, genomics and artificial intelligence. But in the 21st century, people tend to group all technological advances in healthcare as “digital health”. Therefore, it can be said that the concept of digital health includes devices and services that use information and communication technology (ICT) for health-related purposes. These goals broadly include improving the accuracy of diagnosis, careful monitoring of chronic diseases  and improving patient care processes.

Key emerging digital health technologies

Some of the key emerging technologies in India’s digital health system include: digital diagnostic tools such as wearables; Remote monitoring software and hardware and remote monitoring diagnostic tools; telemedicine; mobile health; machine learning; medical imaging; Big Data; Internet of Medical Matters (IoMT); robot-assisted surgery; health self-monitoring  devices; electronic health records (EHR); targeted advertising; personal genomics; personalized or precision medicine; biomarkers; electronic pharmacies; Cloud computing; artificial intelligence (AI); and augmented and virtual reality solutions.

Core legal issues in digital health for our jurisdiction

Data security is critical to ensuring the confidentiality of health information, recommendations and results communicated between patients and healthcare providers. The Information Technology Act  2000 (IT Act), the Data Protection Regulations 2011 and the Mediation Guidelines  2011 are intended to be incorporated by reference in all circumstances and to meet this need; However, no standards have been developed which, due to their strict adherence, force the implementation of data protection and security. In addition, as the number of digital and other innovative health technologies increases,  concerns about patient privacy and information security increase. Data misuse and data protection obligations are major concerns  despite the fact that most data collection, storage and use by healthcare providers would comply with existing data protection laws in India. The current situation is also affected by the lack of proper  training of employees responsible for collecting, handling and processing patient data on the digital health platform. The Personal Data Protection Act was introduced to Parliament on 11 December  2019. The bill established a data protection authority whose purpose is to protect the personal data of individuals. In addition, the main problem is the absence of a comparable law. On 4 August  2022, the Government of India withdrew the Personal Data Protection Act, 2019 (PDP)  from Parliament. According to the government, the new law is likely to be one of four new laws on social media, digital technology, telecommunications and privacy. Instead of a comprehensive law, the government plans to draft special regulations for certain areas of  digital technology. In addition, the new law, which is part of a “comprehensive legal framework”, would replace the PDP law. DISHA has not yet become law.  DISHA establishes national and state health authorities  to prevent  disclosure of health-related information to third parties.  MoHFW has also developed a health information management policy linked to the National Digital Health Mission to protect the privacy of people’s digital health information.

Core healthcare regulatory schemes related to digital health 

There are a number of laws, guidelines and standards governing digital health in India. Digital health technology is generally subject to multiple regulations, although each digital health tool or business model is governed independently. The relevant legislation is the Information Technology Act, the Information Technology (Reasonable Security Practices and Procedures and Sensitive Personal Data and Information) Regulations 2011 (SPDI Regulations) and the Information Technology (Intermediary Guidelines) Regulations 2011 (Intermediary Guidelines). The IT Act, SPDI Rules and Mediation Guidelines form the overall data protection framework in India. Electronic transactions and transmission of electronic data are now permitted thanks to the enhanced security provisions of the Information Technology Act. The IT Law regulates a wide range of online activities, including the authentication of digital signatures and the legal status of electronic documents. The IT Act deals with various types of cyber crimes including hacking and denial of service attacks.

Core regulatory schemes (e.g., data privacy, anti-kickback, national security, etc.) apply to digital health

The current eHealth legal framework in India is governed by the IT Act and the SPDI Rules, which provide some protection to the collection, disclosure and transfer of sensitive personal data such as medical records and registries. In contrast, legislation  lagged behind technological developments and failed to address several key issues. As a result, medical facilities and healthcare providers in India are increasingly storing patient data in electronic medical records (EMRs) and EHRs. The Clinical Establishments (Registration and Regulation) Act 2010 requires all clinical establishments to maintain an EMR for each patient whose record they wish to keep. EHR standards were first published by MoHFW  in 2013. In December 2016, they were updated and published. EHR Standards are a set of global standards that  healthcare providers can use to create and manage EHR standards. Some of the key ongoing digital health initiatives being implemented by  MoHFW are: Reproductive Health (RCH); Integrated Disease Surveillance Program (IDSP); Integrated Health Information System (IHIS); e-hospital; e-Sushrut; Electronic Vaccine Intelligence Network (eVIN); Central Government Health Scheme (CGHS); Integrated Health Information Platform (IHIP); National Health Portal (NHP); National Identification Number (NIN); and online registration system. These programs are well established in the medical field and continue to produce vast amounts of information that can be used in the public interest. Since health care is a national responsibility, the National Health Mission (NHM) supports countries with related services such as telemedicine, teleradiology, teleoncology, tele-ophthalmology and hospital information systems.

What are the principal regulatory authorities charged with enforcing the regulatory schemes?  What is the scope of their respective jurisdictions?

CDSCO is the primary regulatory agency responsible for enforcing the “Drug and Cosmetic Act of 1940” and “rules made thereunder”. In addition, medical practice is regulated by the Medical Council of India. In addition, the Office of the Controller General of Patents, Designs and Trademarks (CGPDTM) is responsible for intellectual property protection, while the Copyright Office is responsible for copyright. Both are divisions of the Ministry of Promotion of Industry and Domestic Trade (DPIIT). The Indian Council of Medical Research (ICMR) has also done a lot to  support MoHFW’s National Digital Health Plan (NDHB) to promote research. In general, the legal and regulatory framework is governed by the following important actions: 

• Information Technology Act,  SPDI Rules and Information Technology Rules 2011 are contained in the Information Technology  Act. 
• The requirements of the new telecommunications policy of 1999  for other service providers. 
• The Narcotic Drugs and Cosmetics Act, 1940 and the Narcotic Drugs and Cosmetics Act, 1945.  
• The  Medical Council of India is governed by the  Medical Council  of India Act, 1956 and the  Medical Council of India (Professional Conduct, Ethics and Ethics) Regulations, 2002.  
• The Drugs and Magic Remedies Act  1954 and the Drugs and Magic Remedies Regulations 1955 regulate the use of drugs and magical remedies.  
• The Commercial Communications Preferences Regulations  2010 and the Unsolicited Commercial Communications Regulations  2007.  •  Clinical Devices Act  2010  

NOTABLE EXAMPLES OF DIGITAL HEALTH

1. TELEMEDICINE

The use of telecommunications technology to provide health care is called telemedicine. Telemedicine in itself is not recognized as a special innovation, but its use in  providing health services to  patients makes it useful today. Telemedicine broadly includes remote radiology, remote consultation, remote nursing, remote surgery, etc., which acts as a mechanism to connect  doctors and  patients and reduce the gap between them. 

1. HEALTH EQUIPMENT  

The development of intelligent devices integrated with  the development of technology can control changes in the functioning of the human body. The raw data used as  input in these devices leads to self-monitoring of various changing health indicators and highlights potential problems that may occur near the property. In addition, such wearable and modern devices  also warn of approaching threats and alert the human body through continuous body tracking and sensors. 

1. M – HEALTH  

It refers to mobile health services offered on a mobile platform under the umbrella of digital health. This is a lucrative option for service providers considering India as the world’s second largest smart hub. The accessibility of digital health combined with the flexibility of m-Health expands the opportunities for online healthcare providers to change the digital healthcare trend  in India.  

4. E – PHARMACY  Recently, a trend has emerged in India that online pharmacies or online pharmacies operate on an online platform  and receive and send orders to customers through mail, courier or delivery personnel. With the help of such online pharmacies, a pharmacist or druggist can meet the needs of a larger number of people outside the regional limitations of an online business model. Online pharmacy models can be of two types where:  
5. me only online pharmacies and  
6. physical pharmacies online.

What are the key issues to consider for use of personal data?

From the point of view of the use and application of personal data, data protection is of primary importance. In 2013, India’s first EHR standards were proposed. Considering the applicability in India, these have been selected from among the best available international EHR standards that have been implemented in the past. As a result, the  EHR Standards document (2016) was alerted and made available in national IT systems for use by healthcare facilities and providers.  MoHFW facilitated its adoption by making standards such as Systematized Nomenclature of Medical Clinical Terminology (SNOMED CT) freely available in India and appointed an interim National Publishing Center to manage the clinical terminology standard, which is gaining global recognition among health IT stakeholders. communities The MoHFW has also proposed a new DISHA Act to regulate data security in the health sector. The purpose of this law is  to protect the privacy, confidentiality, security and standardization of EHRs.  MoHFW plans to establish  DISHA  to promote and implement eHealth standards, monitor eHealth privacy and security, and regulate eHealth storage and exchange.

What is the scope of patent protection?

India enacted and implemented the Patents Act, 1970, which provides patent protection and is in line with the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). In addition to meeting the patentability requirements of novelty, inventive step and industrial applicability, an invention must be excluded from the ambit of Sections 3 and 4 of the Act to obtain patent protection in India. § 3(k) of the Patent Law, which prohibits the patentability of a computer program as such, applies because digital health applications are based on software and a computer program. The Delhi High Court further clarified that not all computer programs are exempted from section 3(k) and an invention is patentable if the computer program has a “technical effect” or a “technical addition”. According to § 3 (i) of the Patent Law, a patent cannot be granted if the program or method relates to “the medical, surgical, curative, prophylactic or other treatment  or  similar treatment of animals or humans to make them diseased. -free or to increase the economic value of them or  their products.” In contrast, the device and method of using the in vitro mechanism are patentable

What is the scope of copyright protection?

The Copyright Act, 1957 protects intellectual property rights in India. Copyright can protect original literary, dramatic, musical or aesthetic works, films and sound recordings. Although copyright registration is not required, it is preliminary evidence in the event of a legal claim. Because digital health apps are essentially software, they fall under the definition of “computer program” and are therefore protected by copyright laws.

What is the scope of trade secret protection?

There is no specific law governing the handling of confidential information and trade secrets in India. But in the new digital healthcare, non-disclosure and confidentiality agreements are commonly used to protect such sensitive information.

What are the rules or laws that apply to academic technology transfers in your jurisdiction?

The idea of ​​academic technology transfer is in its infancy in India. Despite the fact that universities and some companies have embraced the concept and developed rules to strategically deploy innovations and reward inventors, most organizations have not. In addition, the protection of intellectual property rights in  digital health  is still in its infancy; However, it is growing exponentially, and academic and research institutions are  increasingly aware of the importance of protecting and disseminating their data through technology transfer. This trend seems to be gaining momentum and producing better results. Typical rules and activities of academic technology transfer include, but are not limited to, the following steps: assessment and evaluation of patentability and commercialization of the proposed invention; protection of intellectual property in various fields related to this technology; and to seek and find the best partner to license and monetize the offered technology and how the invention works.

What is the scope of intellectual property protection for software as a medical device?

Section k of the Patent Act prohibits the patentability of computer programs in general. The Delhi High Court  clarified that Section 3(k) does not apply to all computer programs and that such programs can be patented if they have a “technical effect” or a “technical addition”. A patent cannot be granted based on Section 3 (i) of the Patent Law if the program or process relates to “the medical, surgical, curative, prophylactic or other treatment process for humans or any  similar treatment method for animals, to make them free from disease or  increase the economic value of them or products”. The hardware and working method of the in vitro mechanism are patentable. Since digital health applications are essentially software, they should be classified as “computer programs” and should be given copyright protection under Indian law. The trademark can also be registered in class 9, which covers computer programs and computer programs.

Importance of IPR Protection

Effective  protection of intellectual property rights is important to support innovation by providing the necessary incentives and rights for inventors and developers  to use their creations. In  digital health, where research and development costs are often high,  intellectual property protection ensures a return on investment, encourages more innovation and attracts investment in the sector.

Challenges in IPR Protection

1. Ambiguities in patentability criteria:  Patentability  of software-related inventions and diagnostic methods remains a gray area in India. The lack of clarity around the criteria for patenting these innovations is a challenge for digital health companies seeking protection for their inventions. 
2. Data protection issues  Digital health innovations often involve the collection and analysis of sensitive patient data. Balancing the need for data understanding with the need to protect patient privacy is a delicate task, and a lack of clear regulations could hinder industry growth.
3. Piracy and counterfeiting  The digital world is vulnerable to piracy and counterfeiting, where unauthorized use of innovative healthcare solutions can undermine the market for legitimate products. Enforcement mechanisms to curb such practices are still being developed. 
4. Challenges of the regulatory framework  The lack of a comprehensive and clear regulatory framework for digital health technologies makes it difficult to obtain and enforce intellectual property rights. Regulatory uncertainty can deter investment and stifle innovation.

Conclusion

Digital health innovations have the potential to revolutionize healthcare delivery in India, but their success hinges on robust Intellectual Property Rights protection. Addressing the challenges in patent laws, data protection, and regulatory frameworks is crucial for creating an environment conducive to innovation. By adopting clear and comprehensive policies, fostering collaboration, and building capacity, India can position itself as a global hub for digital health innovation while ensuring the protection of intellectual property rights. This synergy will not only benefit innovators and investors but also contribute to the overall improvement of healthcare outcomes for the Indian population.

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