With the increasing digitalisation of all aspects of our lives and the high level of adoption of smartphones and smart watches, also the use of digital devices to monitor and improve our health is ever growing. And this does not only cover the privately used smartphone apps for basic health and wellness, which are available in all Appstores, but also software which can be used by professionals to treat, monitor and diagnose patients. This new Software as a Medical Device comprises for example applications monitoring data provided by medical sensors, processing medical images or individualizing drug medications. Since medical technology is falling under various regulations to protect the health of patients such software is heavily regulated, which creates various challenges for the manufacturers including patent related challenges due to its dual nature as software and medical device.

A new emerging product category in the field of medical technology is Software as a Medical Device (SaMD). SaMD is defined by the voluntary regulatory organizations in the International Medical Device Regulators Forum (IMDRF) as “software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device.” Medical devices can be all devices, which can be used from the diagnosis to the treatment of diseases, from the diagnosis to the treatment of injuries, from the investigation to the modification of a physiological process or of the anatomy, for life support, for birth control, for medical disinfection and the in vitro examination of human specimen. Excluded from this definition are pharmacological, immunological and metabolic means.

The manufacturers of those devices are affected by a wide range of regulations. Manufacturers of SaMD are in this case defined as: ““Manufacturer” means any natural or legal person with responsibility for design and/or manufacture of a medical device with the intention of making the medical device available for use, under his name; whether or not such a medical device is designed and/or manufactured by that person himself or on his behalf by another person(s).”

For example in the EU, SaMD is regulated by the Medical Device Coordination Group (MDCG) as part of the Article 103 of Regulation (EU) 2017/745. An important part of this regulation is controlling the potential risks of the use of the software for the patient’s health. Therefore, SaMD is put into various risk categories according to rule 11, such as the highest risk category III for “Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes if such decisions have an impact that may cause death or an irreversible deterioration of a person’s state of health” and the second highest category IIb for “Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes if such decisions have an impact that may cause a serious deterioration of a person’s state of health or a surgical intervention” as well as “Software intended to monitor physiological processes if it is intended for monitoring of vital physiological parameters, where the nature of variations of those parameters is such that it could result in immediate danger to the patient.” The medium risk category IIa is reserved for all other “Software intended to provide information which is used to take decisions with diagnosis or therapeutic purposes” or all other “Software intended to monitor physiological processes”. Finally, the low risk category I comprises all other types of SaMD.

The combination of software as a Medical Device underlying this large amount of regulations as well as being software causes many practical challenges to protect the products properly with patents, which is very important to secure a return on investment and prevent being copied by a competitor. More precisely, one challenge in highly regulated industries such as the medical devices industry lies in the fact, that regulators typically require disclosure of much information, which can create problems acquiring the desired patent protection. Additionally, SaMD is primarily a software product, which can also pose in many jurisdictions challenges for patent protection. What makes the situation on international markets even more complicated is that both medical device regulations and laws for software patents are drastically varying between markets and are also often updated within few years.