Dr Fiona Kellas and Reuben Jacob (pictured below) write about how digital health is a rapidly evolving industry which shows great potential for improving the quality and accessibility of healthcare services that will be available to patients in the future.
Digital health is being driven by two main factors: (1) the increasing use of mobile technology; and (2) the large demands that are being placed on the healthcare industry, for example, due to an ageing population. Digital health can cover the use of data to assist in diagnosis, treatment, prevention and monitoring of diseases, as well as providing for healthcare practitioner support. Thus, the development of digital health technology is expected to lead to lower health care costs, personalised treatments and quicker diagnosis, resulting in better patient outcomes.
The rapid development and evolution of digital health technology means that businesses will need to carefully consider use of Intellectual Property to protect innovations. In contrast to some other healthcare industries which are often developed over a slower period of time, product life cycles in the digital health industry are typically much shorter. Thus, digital health businesses need to develop and regularly revise their IP strategy.
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In addition, businesses should ensure that contracts are put in place when working with any third parties, and that procedures are set up to establish ownership of any IP that may arise during development of a digital health product. Potential inventions should be treated as confidential until the IP situation is understood and any patent and/ or design application relating to the invention are filed. In addition, when developing a product, it may be beneficial to carry out a freedom to operate analysis to check that there are no existing IP rights that relate to the same invention.
Various aspects of a digital health product may be protected using IP, such as the hardware, the software and any associated data analytics. Each of the IP rights that may apply to digital health will be discussed in greater detail below.
Patents
Mechanical, chemical and/ or electrical components of a digital health product may be patentable if they are new and inventive. Methods and protocols associated with using the digital health product may also be patentable. However, digital health products often comprise software and/or a computer-based element which may be difficult to protect using patents. 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. Advantageously, digital health software innovations may be able to overcome this problem since the software is often integrated into a hardware device or used directly by patients, such that they may be considered to have a technical effect.
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Recent case law developments in the US have made it more difficult to protect innovations where the underlying software or technology is built on abstract ideas or laws of nature (Alice v CLS Bank International 134 S. Ct. 2347 (2014)). As a result, it is important for digital health companies to think more strategically about how to acquire patent protection.
Despite the above challenges, many successful digital health companies have been able to secure patent protection for their inventions.
Designs
It may be important to protect aspects of the appearance of a digital health device (such as the shape and/ or colour of the device), especially in light of the competitive nature of the digital health industry. As a result, design protection should be considered if there are aspects of the appearance of the digital health device that may be important in driving sales of the device.
Trade marks
Trade marks may be important in protecting the brand of the product, for example, where a user associates the product with its name.
Copyright and Database Right
Copyright may exist in the programs and algorithms used by the digital health device. Software is considered to be a literary work which may be protected by copyright. However, a problem may arise if the code of the software is slightly altered but the function remains the same, since this may allow third parties to slightly change the code of the software without infringing the copyright. Due to the fact that many inventions in the area of digital health will involve at least some elements of software, technology providers will need to think carefully about their IP strategy.
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. A database is defined as “a collection of independent works, data or other materials which are arranged in a systematic or methodical way and are individually accessible by electronic or other means”. 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.
Since the copyright owner is the creator of the database, digital health companies need to be careful when using a contractor to create a database. This is because the contractor is likely to be the owner of the copyright in the database. Therefore, if a company wants to own the copyright, it must enter into an agreement with the contractor which contains an assignment of the copyright.
Digital health devices often collect and store data which may be transmitted to a healthcare professional or a hospital. 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. Furthermore, companies operating in the area of digital health to be aware of the obligations imposed under data protection legislation for the storage of data and aware of the concerns relating to patient privacy.
The development of digital health products and services may involve a number of different 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.
Conclusion
Digital health is a rapidly developing area which is expected to grow significantly over the next decade. Due to the competitive nature of development in this area, the use of IP to protect innovations relating to digital health is important. A number of IP rights may be used in parallel to protect various aspects of a digital health device and associated software and technology.
