This article is written by Srishti Bansal, a Fourth Year B.A. LL.B (Hons.) Student at Ideal Institute of Management and Technology (GGSIPU), Delhi.
In the 21st century every individual tends to group every technological advancement in healthcare under the head of “Digital Health”. With the onset of covid-19 pandemic, the use of digital health solutions can revolutionize how people worldwide achieve higher standards of health and access services to promote and protect their health and well-being. Digital health provides opportunities to accelerate progress in attaining health and well-being related sustainable development goals.
Meaning of Digital Health
The World Health Organisation defines the term Digital Health as “a broad umbrella term encompassing eHealth, as well as emerging areas such as the use of advanced computing sciences in big data genomics and artificial intelligence.”
It is a process to use information technology or electronic communication tools and processes to deliver health care services or to facilitate better health. The purpose widely includes improving accuracy in diagnosis, monitoring chronic diseases meticulously and improving treatment processes for the patients.
What exactly is Intellectual Property?
Intellectual property is generally non- tangible property. It cannot be physically held or touched. Protections available for intellectual property can be divided into four areas: trade secrets, trademarks, patents and copyright. Patent protection offers a layer of protection for digital health solutions.
IP Considerations in Digital Health
Digital health is rapidly changing the healthcare sector by the way patients interact with doctors and making healthcare services accessible to more people. The major significant change is the use of data to assist in identifying and diagnosing disease as well as detection of factors that may assist in managing and preventing disease. The development of digital health led to lower health care costs and achieved better patient outcomes.
Various aspects of the digital health product may be protected using IP, such as the hardware, the software and any data analytics that may be involved. An example of a digital health product that is typical of those being developed in this area is as follows:
A research team in a medtech company have developed a non-invasive wearable sensor that can measure blood glucose levels over programmed time intervals. The sensor will transmit high or low blood glucose alerts to the sensor wearer or to an individual identified by the wearer. The sensor also stores the collected data in a database that is accessible by the sensor wearer and medical professionals via a web-based application on either a mobile device or a computer. Additional data such as prescription medication, weight, daily exercise and diet can be added and stored in the database.
In the above example, the areas of IP that may be used to provide protection are patents (for example, to protect the mechanical aspects of the device), designs (to protect the appearance of the device), copyright (for example, to protect the programs and algorithms that are used by the device), database right (to protect the data stored in the database). These forms of protection are discussed in greater details below:
Digital health products often comprise mechanical, chemical and/or electrical components which may be patentable if they are novel and inventive. In addition, further aspects of the device, methods and protocols associated with using the device may be patentable. However, digital health products often comprise a software and/or a computer-based element which may be difficult to protect using patents. Therefore, developing a meaningful patent portfolio around these innovations can be challenging.
In Europe, in order for a patent to be granted for a computer implemented invention, a technical problem needs to be solved in a new and inventive manner. Thus, when considering patent protection in Europe, it is necessary to demonstrate that the software component of the digital health product has a technical effect.
In the US, developments over recent years have increased the difficulty associated with protecting innovations where the underlying software or technology is built on abstract ideas or laws of nature. This is due to the finding of the US Supreme Court case Alice v CLS Bank International 134 S. Ct. 2347 (2014) which found that a patent is invalid if the claims relate to an abstract idea, since such abstract ideas are excluded from patentability. Following Alice, it is important for digital health companies to think more strategically about how to acquire patent protection.
Registered and Unregistered Design Protection
Due to the competitive nature of the digital health industry, it may be important to protect aspects of the appearance of the digital health device. For example, it is possible that the customer may be drawn to the product due to its size, colour, or a feature of the design of the user interface of the device. If there are aspects of the appearance of the digital health device that may be important in driving sales of the device, design protection should be considered.
The use of trademarks may be important in protecting the brand of the product, for example, where the user associates the product with its name. This can be seen with brands such as Fitbit ® where the product is associated with the name of the device.
Copyright and Database Right
Digital health devices often collect and store data which may be transmitted to a healthcare professional or a hospital. Data is one of the grey areas of IP and establishing the ownership of the data may be complex. Patients often own their own data and medical records. However, consolidated and anonymised data often belongs to the NHS. In addition, data sets that are licensed from third parties will be subject to the terms of those licenses and the restrictions of any copyright that may apply.
Digital health devices may be linked to a database in which the data is collected and stored. Database Rights are defined in Directive 96/9/EC.
The data stored in a database may be protected: (1) under the law of copyright and the rules that apply in relation to databases; and (2) under the UK Copyright and Rights in Databases Regulations 1997.
Contracts and Licensing
As in other sectors, the development of digital health products and services may involve a number of parties. It is therefore important to assess any contracts and licences that may apply and to be clear about the ownership of any IP that may arise.
The digital health sector is rapidly growing and many medtech companies are moving into this area. Thus, the use of IP to protect innovations in this sector is increasingly important. Whilst there may be challenges associated with IP protection of digital health innovation, many companies are successfully navigating these challenges. The 2030 agenda for sustainable development recognizes that health and development are inter -related and investment in health and other sectors are reinforcing the economic and social inequalities, rapid urbanization and damage to the environment. The government needs to make an effort in harmonizing the IT laws and health care sector that would create an impact on digital health policies.