With advancement of technology, software has rapidly become an essential part of human daily life and became an important part of healthcare products serving both medical and non-medical purposes. With this respect, use of software as a medical device (“SaMD”), which is on its own a medical device, is continuing to increase, and the subject is being addressed by global actors. As SaMD, previously referred to as stand alone software, medical device software, health software, etc., has features particular for the subject matter, regulators have recognized the need to establish a common framework and principles for SaMD. With this article, regulatory approach of global actors to the term SaMD and intellectual property protection matters with this respect is aimed to be discussed.
International Medical Device Regulators Forum (“IMDRF”), a voluntary group of medical device regulators from around the world, established in October 2011, which has created a Working Group on SaMD (“SaMD WG”) has published non-binding documentation providing guidance with respect to stand alone software and SaMD. With the intention to identify commonalities, establish a common vocabulary and develop approaches for appropriate regulatory controls that promote prospective convergence in areas of advanced and innovative technologies in this topic area (i.e. SaMD), SaMD WG has published “Software as a Medical Device (SaMD): Key Definitions” (“IMDRF SaMD: Key Definitions”) in 2013. Accordingly, term SaMD is defined by the 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. The SaMD WG has also agreed upon the framework for risk categorization of SaMD, quality management system of SaMD and the clinical evaluation of SaMD.
European Union’s Regulatory Approach to SaMD
With respect to this subject area, the European Commission services has released a Guidance Document on the Qualification and Classification of Stand Alone Software used in Healthcare within the Regulatory Framework of Medical Devices in January 2012 (and updated in July 2016) (“Guidance Document on Stand Alone Software in Healthcare”), which provides advice on how to determine when a software falls under the definition of a medical device or of an in vitro (In vitro is Latin for “within the glass.” When something is performed in vitro, it happens outside of a living organism) diagnostic medical device. Such criteria apply also to mobile applications. Accordingly, “software” is defined as a set of instructions that processes input data and creates output data; “stand alone software” is defined as a software which is not incorporated in a medical device at the time of its placing on the market or its making available; and with this respect, SaMD is defined as software intended to be used for one or more medical purposes that perform these purposes without being part of a hardware medical device, in parallel with the IMDRF SaMD: Key Definitions.
Pursuant to the European Union (“EU”) Council Directive 93/42/EEC on Medical Devices (“MDD”) “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of: (i) diagnosis, prevention, monitoring, treatment or alleviation of disease, (ii) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, (iii) investigation, replacement or modification of the anatomy or of a physiological process, (iv) control of conception; and which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means. With the Guidance Document on Stand Alone Software in Healthcare, it is explained that not all stand alone software used within healthcare can be qualified as a medical device, accordingly, medical software may be; (i) part of a medical device or an in vitro diagnostic medical device, (ii) accessories of such, (iii) stand alone software, or (iv) not a medical device. Stand alone software can directly control an apparatus (e.g. radiotherapy treatment), can provide immediate decision triggering information (e.g. blood glucose meters), or can provide support for healthcare professionals (e.g. electrocardiogram interpretation).
Pursuant to recital 6 of the EU Directive 2007/47/EC that amended the definition of the term "medical device" under the MDD, "it is necessary to clarify that software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. Stand alone software for general purposes when used in a healthcare setting is not a medical device." With that respect, the intended purpose of the manufacturer would in fact help determine if a software, or wearable in that respect, qualify as a medical device
The United States Food and Drug Administration’s Regulatory Approach to SaMD
The United States (“U.S.”) Food and Drug Administration (“FDA”) also adopts the SaMD definition provided by the IMDRF. According to the explanation provided by the FDA, SaMD is one of three types of software related to medical devices; (i) SaMD, (ii) software that is integral to a medical device (Software in a medical device), and (iii) software used in the manufacture or maintenance of a medical device. However, contrary to the Guidance Document on Stand Alone Software in Healthcare which embrace both software and mobile applications as medical device, the FDA introduces the term "software functions" which includes mobile applications and provides a separate mobile medical application (“MMA”) definition. Accordingly, the FDA defines MMA as a mobile application, which meets the definition of a medical device, and is an accessory to a regulated medical device or transforms a mobile platform into a regulated medical device.
Pursuant to the Section 201(h) of the Food, Drug, and Cosmetic Act, a “medical device” is determined as an instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part, or accessory which is (i) recognized in the official National Formulary, or the U.S. Pharmacopoeia, or any supplement to them, (ii) intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, or (iii) intended to affect the structure or any function of the body of man or other animals, and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
As per the FDA’s Policy for Device Software Functions and Mobile Medical Applications issued on September 25, 2013 and updated on September 27, 2019, the FDA intends to apply its regulatory oversight to only those software functions that are medical devices and whose functionality could pose a risk to a patient’s safety if the device were to not function as intended. This approach to overseeing device software functions is consistent with the FDA’s existing approach to overseeing medical device functionality of a product and the risks it poses to users regardless of the platform. With this respect, it is possible to imply that the FDA considers that device software functions poses the same or similar potential risks to the public health as currently regulated devices if they fail to function as intended.
Turkey’s Regulatory Approach to SaMD
Under Turkish legislation, in parallel with the EU directives regarding medical devices, along with other various means, software including the software intended by its manufacturer to be used specifically for diagnostic and/or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of (a) diagnosis, prevention, monitoring, treatment or alleviation of disease, (b) diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap, (c) investigation, replacement or modification of the anatomy or of a physiological process, or (d) control of conception; which does not achieve its principal intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its function by such means is considered a medical device pursuant to the Regulation on Medical Devices. In addition, under the Annex IX on Classification Criteria of the Regulation on Medical Devices (“Classification Criteria”) it is specified that software which drives a device or influences the use of a device would fall automatically in the same class of such medical device. As per the Classification Criteria and in parallel with the MDD, stand alone software that qualify as a medical device is considered to be an active medical device, which is defined as any medical device operation of which depends on a source of electrical energy or any source of power other than that directly generated by the human body or gravity and which acts by converting this energy.
However, “software” or the term “stand alone software” which is mentioned under the Classification Criteria are not defined under the Regulation on Medical Devices or other Turkish regulations, Regulation on in vitro Diagnostic Medical Devices or Regulation on Active Implantable Medical Devices. As Turkish regulations regarding medical devices are prepared in accordance with the EU legislation, EU approach to software intended for healthcare and SaMD as explained above should be taken into consideration regarding the subject matter.
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