Soapbox

When Health-Related Apps Qualify as Medical Devices in the European Union

By Emmanuel Garnier
August 11, 2017


• Categories: 05-Quality/Regulatory, Market Access, RC - Medical Device Audits, Certification & Verification, Soapbox

The Advocate General (ECJ case C329/16 Snitem & Philips France vs. Prime Minister and Health Minister) considers that a prescription support tool falls within the category of a medical device as defined in Directive EC/93/42 when the functionalities of the application/software provide practitioners with “information allowing the prescriber to detect contraindications, drug interactions and excessive doses”, even though it does not itself act in or on the human body.

Although the Directive provides since 2007 that software “is a medical device when specifically intended by the manufacturer to be used in one or several (…) medical purposes”, no decision from the European Court of Justice (ECJ) has ever determined, so far, the conditions under which software could qualify as a medical device. The opinion (and related decision) is thus important, as it will have, apart from the specific case at hand (see below), major impacts on manufacturers and developers of prescription support apps.

The Advocate General of the European Court of Justice determines the conditions under which health-related apps qualify as medical devices under current EU Directives.

Background

SNITEM (French medical device manufacturers association) and Philips France (Philips) have launched two actions before Conseil d’État (French administrative Supreme Court) asking for the withdrawal of French Decree n° 2014-1359 of November 14, 2014 that has created the obligation to obtain an official certification from HAS (Haute Autorité de Santé) for all prescription support app/software. Claimants have put forward notably that the certification requirement does not comply with European law since the Decree creates an additional obligation of certification issued by French authority applying to special type of software that may have already been granted CE mark.

Indeed, Philips manufactures and commercializes the prescription support software called Intellispace Critical Care and Anesthesia (ICCA), which provides physicians with information required for appropriately prescribing medicines, notably concerning contraindications, drug interactions and excessive doses. ICCA has obtained CE mark, which evidences conformity of such software to the requirements provided by the Directive.

Unsurprisingly, and before ruling on the merits of the claim, Conseil d’État has questioned whether software such as ICCA are medical devices as defined by Directives. Indeed, the argumentation put forward by SNITEM and Philips makes it relevant to distinguish between software that are not medical devices and those that need to be qualified as medical devices: Only the second category would be impacted by the arguments raised by the claimants.

Question referred to the ECJ

The Conseil d’Etat has thus referred the following question on June 13, 2016:

“Must [Council] Directive 93/42/EEC of 14 June 1993 [concerning medical devices] be interpreted as meaning that software, the purpose of which is to offer to prescribers practising in towns, a health establishment or a medico-social establishment support for determining a drug prescription, in order to improve the safety of prescription, facilitate the work of the prescriber, encourage conformity of the prescription with national regulatory requirements and reduce the cost of treatment at the same quality, constitutes a medical device within the meaning of that directive, where that software has at least one function that permits the use of data specific to a patient to help his doctor issue his prescription, in particular by detecting contraindications, drug interactions and excessive doses, even though it does not itself act in or on the human body?”

Reasoning Proposed by the Advocate General

Grounding his opinion on the interpretation of Directive EC/93/42, relevant (though scarce) case law from ECJ on this subject (notably Brain Products and Oliver Medical decisions), and available MEDDEVs, the Advocate General (Campos Sanchez-Bordona) proposes to answer to Conseil d’Etat that a software/app is a medical device if “it provides the practitioner the information allowing him/her to detect “contraindications, drug interactions and excessive doses”.

According to the Advocate General, the ICCA software is an instrumental tool for health professionals, facilitating the therapeutic and control tasks of patients under anesthesia or in intensive care. ICCA is not, therefore, a software program that would only intervene after the doctor has decided on the appropriate treatment, but precisely, a software program that helps him determine the adequate prescription: “The medical purpose required by the Directive EC/93/42 for software to qualify as a medical device appears to be clearly one of those to which the characteristics of ICCA respond”.

Consequently, in view of the aforementioned functions of the ICCA software, the Advocate General retains that ICCA falls within the definitions of “active medical device” and “active device for diagnosis” provided by the Directive, which include standalone software which, alone or in combination with others, provide “information for the detection, diagnosis, control or treatment of physiological conditions, health conditions, diseases or congenital malformations”.

In this respect, the Advocate General emphasizes that soft law guideline MEDDEV 2.1/6 (relating to the qualification of standalone software used in the healthcare sector) provides that when software does not perform any action on the data or when this action is limited to storage, archiving, communication, simple search or lossless data compression, it cannot be described as a medical device. Conversely, for the Advocate General, if the software creates or modifies medical information to help the health professional to use this information, it can be a medical device.

Furthermore, according to the Advocate General, the collection, analysis and processing of patient data—operations with which the ICCA software helps healthcare professionals detect contraindications, drug interactions and excessive doses—take away ICCA from those computer tools that have only a purely administrative type. He adds: “Based on the patient data that has been collected (and which can be derived from other systems or devices to which this patient is connected) and with the help of its calculation engines, the software automatically converts this data into useful information for the health professional, while suggesting to him the appropriate doses of the medicinal product (…)” this function thus allowing “the exploitation of data specific to a patient in order to help his practitioner to establish his prescription”.

The Advocate General finally adds: “In this way, it facilitates the work of the anesthesiologist or the intensive care practitioner in deciding the appropriate treatment to be given to the patient, even in real time and on the basis of the references provided the software”.

For the above-mentioned reasons, the Advocate General proposes to reply in the following terms to the question raised by Conseil d’Etat: “Subject to the assessment that the referring court will have to make its functionalities, prescription assistance software, such as the one at issue in the present case, can be described as a medical device within the meaning of Article 1 (2) (a) of Directive EC/93/42 and of the Council of 14 July 1993, relating to medical devices in so far as it provides the practitioner with information that will allow him to detect contraindications, drug interactions and excessive doses”.

Health-related apps in the new Regulation: Clarification needed

Beyond the present case and the future of the Decree on certification issued in 2014, the ECJ interpretation of the Directive will have immediate and major consequences for manufacturers, since the marketing, in each Member State, of software which must be qualified as medical device is subject to very strict and binding requirements.

The question asked to ECJ, which is based on the provisions of Directive EC/93/42, remains of importance in view of the application of the new Regulation 2017/745, which has preserved—by further detailing it—dual category of software for medical purposes on the one hand and general purpose software used in a medical environment on the other hand. If, unlike the former, the latter are not medical devices, the medical functionalities carried by the software will remain key in determining the medical purpose pursued and hence the qualification of a medical device.

The ECJ’s decision is expected in the coming weeks.