Ruling on dermatology app could have massive impact on...

Ruling on dermatology app could have massive impact on…

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/picture alliance, Dermanostic GmbH

Berlin – A legal dispute between the two competitors Onlinedoctor and Dermanostic could have a fundamental impact on the telemedicine market. The umbrella organization for digital healthcare accuses the court of not having examined the case correctly.

The Hanseatic Higher Regional Court (OLG) in Hamburg had ruled that asynchronous telemedical services must also be certified as medical devices of risk class IIa if they do not collect their own data for the purpose of medical diagnosis, but transmit patient data in a structured manner.

The legal dispute originated with Onlinedoctor. The company had taken legal action against its competitor, accusing it of not being sufficiently certified for the teledermatology services it offered.

Both companies had applied in parallel for a tender from Techniker Krankenkasse (TK). In 2020, Onlinedoctor was awarded the contract and has since been able to offer TK policyholders a so-called digital skin check.

Onlinedoctor itself does not yet have certification as a medical device in risk class IIa under the EU Medical Device Regulation (MDR). However, the company says it launched its product in February 2021, when the predecessor regulation to the current MDR was still in force, according to which software products such as asynchronous skin checks were to be classified as class I medical devices.

Transitional regulations apply to products that were already on the market before the MDR came into force, and Onlinedoctor is also subject to these. This does not apply to Dermanostic, the company argued. The structure of the product therefore requires certification as a Class IIa medical device, which is why Dermanostic must take its product off the market.

However, the Hamburg Regional Court (LG) rejected an application for a temporary injunction to this effect last August. According to the Chamber for Commercial Matters, the Medical Devices Regulation requires that the software itself generates the information required for the medical decision.

An application that, for example, collects blood pressure or other vital data and sends it to a doctor would therefore fall under risk class IIa. However, with Dermanostic – as with Onlinedoctor – patients upload photos of skin lesions that they have taken themselves and then fill out a form. Both are sent to dermatologists, who make diagnoses on this basis and, if necessary, issue private prescriptions.

Onlinedoctor filed an appeal against the LG’s decision and thereby achieved an amendment, whereby Dermanostic was prohibited from continuing to distribute its software without certification according to risk class IIa, IIb or III. Dermanostic, in turn, filed an appeal against this.

The company was ultimately concerned with the interpretation of the word “provide”: “Software intended to provide information that is used to make decisions for diagnostic or therapeutic purposes belongs to class IIa,” the MDR states. The term is ambiguous, argued Dermanostic, which is why the purpose of the regulation and the will of the regulator are crucial.

Accordingly, a pure data transmission and communication solution cannot create any kind of patient risk that needs to be mitigated by a higher classification. Rather, the software must at least make some kind of diagnostically relevant contribution of its own in order to be classified in Class IIa.

This is not the case with the anamnesis questionnaires in the app, as these were developed exclusively by professionally trained people, so that the app does not make any independent decisions about the type and extent of the questions asked, but merely displays the questions specified by human doctors for the specific clinical picture in question.

Dermanostic was successful with this argument: At the beginning of the year, the regional court lifted the temporary injunction. Now Onlinedoctor has appealed, pointing out that the software decides which further questions to ask a patient based on predefined programming and previous answers.

The app therefore influences the medical history and the diagnosis of an illness, which the patient must first classify themselves. This is not done on the basis of a medical decision on a case-by-case basis – the software intervenes in the diagnostic process and influences it.

In addition, the app requires the patient to make their own assessment of the clinical picture, initially stating the possible illness. The patient is then given a choice of possible answers or diagnoses such as acne, rosacea, psoriasis or moles.

Based on this, the patient receives the questions that the app considers relevant for the selected illness. The Higher Regional Court largely followed this argument: the app provides doctors with the results of a structured collection of medical data.

“If the defendant objects in this context that a team of experts ultimately considered the questions, so that there is no difference to the dermatologist on site, it must be countered that software is always a program created by people who have hopefully programmed it on the basis of sufficient expertise, so that the fact that an ‘expert team of dermatologists’ developed the questions or specified the programming cannot be a suitable criterion for differentiation,” says the judgment, which was given to the German Medical Journal is present.

In addition, the principle of interpretation “effet utile” created by the European Court of Justice (ECJ) speaks against Dermanostic’s interpretation of the word “supply”: According to this principle, EU law provisions always have the greatest possible effect in the event of doubts about interpretation. If it is not clear whether “supply” only includes the collection of data or also the pure transmission, the latter applies.

Onlinedoctor sees this as “a groundbreaking ruling for telemedicine in Germany,” as the company says. It is a key decision for the healthcare industry, as most asynchronous telemedicine providers in Germany have not undergone certification and the costs and resource expenditure for classification as a Class IIa medical device are considered very high in expert circles.

“Even though the OLG ruling is an individual case, it is a guideline for all providers of comparable software products,” explained Theresa Sieverding, Chief Legal Officer at Onlinedoctor. The OLG has for the first time established general guidelines for interpreting the MDR classification rule for software products. “It is highly likely that other courts will follow the guidelines of this decision if they have to assess similar products.”

Managing Director Tobias Wolf also expressly welcomed the decision as an important signal. “The ruling now provides clarity and a clear guideline for asynchronous teledermatology,” he said. “For us as a team, the ruling confirms that we should invest the high amount of time and money in certification as a medical device in risk class IIa.”

Dermanostic, however, contradicts Onlinedoctor’s claim that the competitor must now withdraw its offer from the market. “We are still available online,” stressed managing director Alice Martin when asked. In fact, Dermanostic had to take the previous app off the market and replace it with a new app in which adjustments had been made to the intended purpose and the questionnaire so that the data from the patient’s answers would no longer reach the doctors in a pre-structured form.

“We now have to ask small children, for example, whether they have had unprotected sex. That is absurd, but according to the ruling of the Higher Regional Court, it is necessary,” said Martin. In medicine, there are a large number of paper questionnaires used, the results of which are then used in the medical diagnosis. “None of these questionnaires is a Class IIa medical device. Why an app questionnaire should be a medical device is absolutely incomprehensible.”

She also considers the ruling to be potentially fundamental and fears that it could have enormous implications for the entire market for telemedicine, but also for digital health applications (DiGA). According to the court’s legal opinion, every application and every questionnaire that transmits structured data from patients to doctors would fall into Class IIa.

“This would have massive consequences for many providers who would have to apply for certifications and would again unnecessarily slow down the digitization of the healthcare system,” criticized Martin. “It is not clear what added value or safety gains patients would get from this, as the requirements for the quality management system and the safety and performance requirements for risk classes I and IIa are identical.”

This makes the topic highly relevant for the umbrella organization for digital healthcare, which represents the majority of DiGA providers. Board member and legal advisor Julian Braun criticizes the OLG: The court did not even examine the central question of whether the software in question is actually a medical device within the meaning of the MDR.

If it had carried out this examination and based its decision on the regulatory guidelines, Braun said it would have had to come to the conclusion that it was not a medical device. Then the question of risk classification would have been obsolete. “Because the Hamburg Higher Regional Court did not carry out this examination step, it ultimately – logically – reached the wrong conclusion,” he explained when asked.

Association head Paul Hadrossek, on the other hand, contradicts the assessment of Onlinedoctor managing director Tobias Wolf: The ruling did not create any clear clarity, but rather showed the considerable differences in the assessments by various authorities and institutions, explained Hadrossek.

“It is urgently necessary to create future-proof regulations that enable doctors to work digitally, provide contemporary, effective patient care and create a sustainable basis for innovation.” © lau/aerzteblatt.de

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