Regulatory Overview of Wearable Technologies in Healthcare

Wearable technologies, used in various sectors including health, fitness, security, gaming, fashion, etc., enable the continuous monitoring of human physical activities and behaviors, as well as physiological and biochemical parameters and are becoming a substantial part of daily life. This article aims to discuss regulations under Turkish law which may be applied to wearable technologies to monitor health and disease.

Use of Wearable Technology to Monitor Health

Wearable technology is a broad concept both in terms of the technology used and the intended purpose. With use of wearable technology in health and medical sectors, effectiveness, quality of life, and service providing rates have increased whereas the costs have declined. It is predicted that the dominant sector in the wearable technology industry will remain the health care sector, which merges medical, fitness, and wellness and that the wearable technology market is now entering a rapid growth phase based on leading indicators such as patent filings over the years, cost reduction of key enabling technologies, and increased functionality of devices.

Wearable technologies enable the continuous monitoring of human physical activities and behaviors, as well as physiological and biochemical parameters during daily life. The most commonly measured data include vital signs such as heart rate, blood pressure, and body temperature, blood oxygen saturation, posture, and physical activities. Some wearable technology applications are designed for prevention of diseases and maintenance of health, such as fall identification and prevention, physical activity monitoring, and mental status monitoring. Wearable devices are also used for patient management for patients with stroke, brain and spinal cord injuries, and chronic pulmonary diseases; and disease management for heart disorders, blood disorders, diabetes, Parkinson’s disease, autism, etc. In addition, researchers have already managed to use nanotechnology to improve biological imaging so that clinicians can detect accumulations of minuscule particles or molecular signals associated with health problems.

Regulatory Framework of Medical Use of Wearable Technologies under Turkish Law

Using wearable technology to monitor health would raise the question whether such use would necessitate wearable technology to be considered as a medical device and the relevant legislation to be applied. There are examples around the world with respect to widely used wearable technologies to be deemed medical devices: the U.S. Food and Drug Administration (“FDA”) has cleared Apple Watch that incorporates heart monitoring capabilities such as heart rate and heart rhythm detection and a personal electrocardiogram (“ECG”) and fall detection along with other consumer ECG devices. In addition to receiving De Novo clearance in the U.S. from the FDA, the ECG application and irregular rhythm notification of the Apple Watch (“ECG App”) has also been CE marked and cleared in the European Economic Area.

In order to be able to discuss whether wearable technology to monitor health may be deemed as a medical device, the definition of medical device under Turkish law should be examined. There are three distinctive regulations regarding medical devices under Turkish law, which are coordinated with the European Union (“EU”) directives regarding medical devices: (i) Regulation on Medical Devices –prepared in accordance with EU Council Directive 93/42/EEC on Medical Devices (“MDD”), (ii) Regulation on in vitro Diagnostic Medical Devices –prepared in accordance with EU Council Directive 98/79/EC on in vitro Diagnostic Medical Devices (“IVDMD”), and (iii) Regulation on Active Implantable Medical Devices –prepared in accordance with EU Council Directive 90/385/EEC on Active Implantable Medical Devices (“AIMDD”).

Regulation on Medical Devices

Pursuant to the Regulation on Medical Devices, “medical device” means any instrument, apparatus, appliance, software, accessory or other material, 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 (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; 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. Consequently, in order a wearable technology product to qualify as a medical device as per the Regulation on Medical Devices, such product would need to meet the criteria determined under the definition given above. With this respect, wearable technology intended for monitoring health, which may be considered as a means of use for wellbeing may not be considered a medical device, whereas wearable technology intended for monitoring disease, injury, or handicap as defined under the Regulation on Medical Devices may qualify as a medical device provided that other aspects of the definition is also met.

According to the Turkish Medicines and Medical Devices Agency (“TMMDA”), “pharmacological effect” can be defined as the effect that occurs between the molecules of the substance in question and the cellular components, often expressed as receptors, that directly respond or eliminate the response to another agent; “immunological effect” can be defined as the events that occur within or on the surface of the body through the stimulation or activation of products or cells that create specific immune reaction; whereas “metabolic effects” can be defined as the effects that cause changes in body functions by initiating, terminating or changing the rate of chemical reactions that normally take place.  As defined by the TMMDA in parallel with the European Medicines Agency, a “medicinal product” is defined as a substance or combination of substances that is intended to treat, prevent or diagnose a disease, or to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action. Subsequently, as per the Regulation on Medical Devices, in cases where the above explained principal intended action is achieved by pharmacological, immunological or metabolic means, the product would not fall under the definition of medical device but medicinal product.

As per the Regulation on Medical Devices and in parallel to the MDD, medical devices are classified under four categories: Class I, Class IIa, Class IIb, and Class III. Classification rules are determined in detail under the Annex IX on Classification Criteria of the Regulation on Medical Devices (“Classification Criteria”) and accordingly, application of the classification rules shall be governed by the intended purpose of the devices. Classification rules mainly focus on a device’s invasiveness, duration of contact with a body, whether the medical device is active, and the risk the device poses to the user. As per the Classification Criteria, an “invasive device” is a device which, in whole or in part, penetrates inside the body, either through a body orifice (any natural opening in the body, as well as the external surface of the eyeball, or any permanent artificial opening or through the surface of the body) or through the surface of the body. In addition, “active medical device” 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; as per the Classification Criteria, stand alone software is considered to be an active medical device.

Classification rules which may be applicable to wearable technologies is aimed to be discussed under this paragraph, accordingly, it is important to note that not all classification criteria has been mentioned. Pursuant to the classification rules determined under the Classification Criteria, all medical devices and active medical devices that are non-invasive would be classified as Class I, provided that other classification rules regarding classes other than Class I under the Classification Criteria apply. In addition, if the device is intended to be used in combination with another device, the classification rules shall apply separately to each of the devices and software which drives a device or influences the use of a device would fall automatically in the same class. Invasive medical devices with respect to body orifices, excluding surgically invasive devices, that are not intended for connection to an active medical device or intended for connection to a Class I active medical device, would be classified as (i) Class I if (a) they are normally intended for continuous use for less than 60 minutes (“transient”) or (b) they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity, (ii) Class IIa if (a) they are normally intended for continuous use for not more than 30 days (“short term”) or (b) they are used in the oral cavity as far as the pharynx, in an ear canal up to the ear drum or in a nasal cavity and are not liable to be absorbed by the mucous membrane, (iii) Class III if normally intended for continuous use for more than 30 days (“long term”). In addition, invasive medical devices with respect to body orifices, excluding surgically invasive devices, intended for connection to an active medical device classified under any class other than Class I, would be classified as Class IIa. Active medical devices intended for diagnosis including active medical devices that are intended to allow direct diagnosis or monitoring of vital physiological processes would be classified as Class IIa, whereas medical devices specifically intended for monitoring of vital physiological parameters, where the nature of variations is such that it could result in immediate danger to the patient, for instance variations in cardiac performance, respiration, activity of central nervous system would be classified as Class IIb.

FDA, for instance, embraces a slightly different approach to definition and classification of medical device. Per 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 United States 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. Similar to the EU law and Turkish legislation, intended use and indications for use of the product is an important aspect for determination whether such product may qualify as a medical device.

FDA has classified and described distinct types of devices and organized them in the Title 21 of the Code of Federal Regulations (“CFR”) into medical specialties such as Cardiovascular devices or Ear, Nose, and Throat devices. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device, the intended use of the device, the indications for use, and the risk the device poses to the user. Accordingly, devices are classified under three categories: Class I, Class II, and Class III. Class I includes devices with the lowest risk and Class III includes those with the greatest risk. For each of the devices classified by the FDA, a general description including the intended use, the class to which the device belongs (i.e., Class I, II, or III), and information about marketing requirements is included in the CFR. FDA has granted De Novo clearance for the Apple Watch’s ECG App and classified it as a Class II medical device.

Stand Alone Software and Software as a Medical Device

Under Turkish legislation, in parallel with the EU directives regarding medical devices, 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.  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 the other Turkish regulations discussed under this article. As Turkish regulations regarding medical devices are prepared in accordance with the EU legislation, EU approach to software intended for healthcare should be considered.

International Medical Device Regulators Forum (“IMDRF”), defined the term SaMD 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 addition, 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 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. 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. To be deemed a medical device, software in its own right should be specifically intended by the manufacturer to be used for the medical purposes mentioned in the respective definition, therefore stand alone software for general purposes when used in a healthcare setting would not be considered 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. As stated above, 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 under Turkish legislation.

The 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. 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. 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. The ECG App’s generic medical device type is identified by the FDA as “An electrocardiograph software device for over-the-counter use creates, analyzes, and displays electrocardiograph data, and can provide information for identifying cardiac arrhythmias. This device is not intended to provide a diagnosis.” Accordingly, the ECG app is a software-only mobile medical application intended for use with the Apple Watch to create, record, store, transfer, and display a single channel ECG which determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform.

Regulation on Active Implantable Medical Devices

Pursuant to the Regulation on Active Implantable Medical Devices and in parallel to the AIMDD, “active medical device” means any medical device relying for its functioning on a source of electrical energy or any source of power other than that directly generated by the human body or gravity; and “active implantable medical device” means any active medical device which is intended to be totally or partially introduced, surgically or medically, into the human body or by medical intervention into a natural orifice, and which is intended to remain after the procedure. The definition of medical device is the same with the definition under the Regulation on Medical Devices.

As per the exemplative list of active implantable medical devices under the Guidance Document on Field of Application of AIMDD, implantable cardiac pacemakers, implantable defibrillators, implantable nerve stimulators, diaphragm stimulators, implantable active monitoring devices, etc. are covered under the Regulation on Active Implantable Medical Devices.

Regulation on in vitro Diagnostic Medical Devices

Pursuant to the Regulation on in vitro Diagnostic Medical Devices, “in vitro diagnostic medical device” means any (i) medical device which is a reagent, reagent product, calibrator, control material, kit, instrument, apparatus, equipment, or system or (ii) specimen container, whether vacuumed or not, used by their manufacturers to store and preserve specimens taken from the human body for in vitro medical diagnostic examination, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: (a) concerning a physiological or pathological state, or (b) concerning a congenital abnormality, or (c) to determine the safety and compatibility with potential recipients, or (d) to monitor therapeutic measures.

 

As per the Regulation on in vitro Diagnostic Medical Devices, the definition of medical device is slightly different than the definition under the Regulation on Medical Devices. Accordingly, “medical device” means any instrument, apparatus, appliance, accessory or other material, whether used alone or in combination, including the software necessary for its proper application and products derived from inanimate animal tissue, 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 or compensation for an injury or handicap, (c) investigation, replacement or modification of the anatomy or of a physiological process, (d) control of conception or administer a medicine 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.

Pursuant to the Regulation on in vitro Diagnostic Medical Devices in vitro diagnostic medical devices must meet the essential requirements which apply to them determined by Medical Device Advisory Committee of the EU, taking account of the intended purpose of the devices concerned.

In light of the above explanations, even though software and mobile applications used in health sector may fall under the Regulation on Medical Devices or the Regulation on in vitro Diagnostic Medical Devices, as in vitro medical devices are used for the examination of specimens that have already been taken out of the human body, in other words they do not achieve their principal intended action in or on the human body, it is possible to say that the Regulation on in vitro Diagnostic Medical Devices would most likely not apply to wearable technologies.

Since wearable technology currently used for monitoring health is non-invasive and non-implantable to a large extent, provided that it fulfills the criteria to be deemed as a medical device as explained above, the Regulation on Medical Devices would be applied. However, depending on the technical features of the wearable technology, it is possible to say that it may fall under the scope of the Regulation on Active Implantable Medical Devices.

Even though wearable technology tends to refer to items that are non-invasive and non-implantable which can be put on and taken off with ease, there are more invasive versions of the concept as in the case of implanted devices. In addition, both concepts (wearable technology and medical device) include various aspects in terms of used technology, application and use of such technology, and intended purpose. As explained in detail above, purpose of medical device under Turkish law involves monitoring of disease, injury, or handicap, however, such medical device may fall under different regulations provided that the criteria in relation to the application and use of such medical device is met. With this respect, wearable technology intended for monitoring health, which may be considered as a means of use for wellbeing may not be considered a medical device, whereas wearable technology intended for monitoring disease, injury, or handicap as per the definition of medical device under the Turkish legislation may qualify as a medical device provided that other aspects of the definition is also met. Therefore, with regard to the abovementioned regulations under the Turkish law, the applicable regulation with respect to use of wearable technologies in order to monitor disease is not categorical. Consequently, in practice, misconception or false assessment of whether a wearable technology product would be deemed a medical device or the applicable legislation with regard to a wearable technology product which may be deemed as a medical device is commonly observed.

 

Author: Simge Kılıç