I. Introduction
The promise of telemedicine lies in its ability to decouple medical expertise from physical geography.Footnote 1 As the European Union (EU) is founded on the four fundamental freedoms, cross-border telemedicine should represent the ultimate expression of a truly integrated internal market. However, a significant legal paradox remains: while digital services easily overcome national borders de facto, the medical act remains legally confined within them.Footnote 2 Telemedicine, thus, eludes a monolithic definition, appearing instead as a complex legal operation where health, technology and market interests converge. Positioned at the intersection of public health protection and the advancement of digital policy, its inherently hybrid nature challenges traditional legal categories and serves as a primary observatory for the current tensions within the European integration process.
With its judgement of 11 September 2025, in Case C-115/24,Footnote 3 UJ v Österreichische Zahnärztekammer (the hereafter DrSmile case), the Court of Justice of the European Union (CJEU) delivered its first-ever ruling specifically addressing the implementation of cross-border telemedicine. The Court was tasked with mediating a high-stakes clash between traditional professional dental regulations in Austria and a business model involving the cooperation between an Austrian dentist and a German-based digital platform.
By challenging this partnership’s legality, the Österreichische Zahnärztekammer (the Austrian Dental Chamber) forced the Court to clarify the interplay between Directives 2011/24/EU (Patients’ Rights),Footnote 4 2005/36/EC (Professional Qualifications),Footnote 5 and 2000/31/EC (E-Commerce).Footnote 6 The relationship between these instruments is highly controversial, as they often dictate conflicting country-of-origin or destination-country principles for telemedicine.
This case note first outlines the factual and procedural backdrop of the dispute before identifying the core legal findings – specifically the legal definition of “telemedicine” and the affirmation of the country-of-origin approach – that offer genuine added value to the evolving digital health landscape. Finally, it situates the ruling within the broader societal and legislative context by arguing that while the Court provides the necessary judicial scaffolding for market integration through its affirmation of the country-of-origin approach, its formalist insistence on separating digital and physical components inadvertently carves a clinical-legal gap into the reality of modern care, potentially muddying the waters of expert-led governance in an era of increasingly blended treatment.
II. The factual background
The core of the dispute lies in a hybrid business model for orthodontic treatment involving transparent aligners that challenges traditional dental practice boundaries. Under this arrangement, UJ (the Appellant) operated an authorised dental practice in Austria, where she performed the physical, chairside components of the treatment. Central to the conflict is UJ’s collaboration with two German-based entities (the Interveners): Urban Technology, the commercial engine behind the DrSmile brand, and DZK Deutsche Zahnlinik (DZK), which handles the clinical and contractual aspects of these treatments, including ongoing monitoring of aligner usage and progress through a mobile app.
This service model functions as a digital–physical hybrid. First, patients use the DrSmile website to book appointments with “partner dentists” like UJ for initial consultations, diagnostics, and preparatory procedures. The resulting clinical materials are transmitted to DZK in Germany, which acts as the sole contracting party, provides the treatment plan, and supplies the aligners. While UJ performs the physical clinical work in Austria, ongoing monitoring is conducted via a mobile application managed by DZK, constituting the Information Communication Technology (ICT) element that brings the arrangement into the sphere of cross-border telemedicine. Consequently, while the physical clinical work was anchored in Austria, the specialised orthodontic planning, medical oversight, and progress monitoring were conducted remotely from Germany, setting the stage for a jurisdictional tug-of-war.
The Austrian Dental Chamber challenged the legality of this cooperation, contending that it violated the Austrian Dentists Act (Zahnärztegesetz), which strictly requires the “personal and direct” practice of dentistry.Footnote 7 This creates the central pivot of the case: whether these hybrid services constitute “telemedicine” under EU law. If classified as such, the service would be governed primarily by the country-of-origin principle (the laws of Germany); if classified as traditional healthcare, the model remains subject to the more restrictive professional and corporate regulations of the Member State of treatment (Austria).
The Austrian Dental Chamber initiated legal proceedings seeking a provisional injunction to compel UJ to cease her participation, arguing she was effectively enabling a foreign corporation to practice dentistry on Austrian soil. The lower courts initially struggled with whether the involvement of a German-based platform shifted the regulatory jurisdiction. Upon reaching the Oberster Gerichtshof (Supreme Court of Austria), the latter recognised that the resolution depended entirely on the interpretation of EU secondary law. Acknowledging that the legal definition of “telemedicine” remained undefined in a hybrid context – where chairside and remote care are inextricably linked – the Supreme Court of Austria suspended the proceedings and referred several questions to the CJEU to define the autonomous concept of “telemedicine” under Article 3(d) and assign a definitive regulatory home to these “complex medical treatment”.
III. The ECJ’s reasoning: mapping the digital frontier
The Court of Justice’s (the Court) findings in DrSmile case provide a definitive interpretation of the legal boundaries governing digital health, specifically clarifying the autonomous definition of “telemedicine” under Article 3(d) of the Patients’ Rights Directive. This ruling is pivotal because it determines the switch between the country-of-origin principle, which consists of the country where the provider is established and favours the expansion of digital platforms, and the destination-country principle, namely, where the telemedicine services are “consumed” and which protects national regulatory sovereignty.
In addressing the preliminary reference, the Court moved beyond the mere facts of the dispute to establish a principled framework for cross-border care, stripping the case down to its regulatory essentials.
1. The strict criterion of “exclusivity” and legal fiction of location
The Court first addressed Question 2, seeking to clarify whether telemedicine encompasses hybrid treatments or only services delivered entirely via ICT. Adopting a strict interpretation of Article 3(d) of the Patients’ Rights Directive, the Court ruled that the prefix “tele-” marks a conceptual boundary: healthcare must be provided at a distance.
This interpretation is rooted in a systematic understanding of Article 3(d).Footnote 8 While sentence 1 establishes the general rule that the “Member State of treatment” is where healthcare is actually provided, Article 3(d) sentence 2 creates a vital exception:
In the case of telemedicine, healthcare is considered to be provided in the Member State where the healthcare provider is established.
The Court views this rule as a distinct exception rather than a mere clarification. The phrase “is considered to be” indicates the creation of a legal fiction. Under normal circumstances, if a doctor in Germany treats a patient physically located in France via a screen, the “service” is arguably being consumed in France. Without Article 3(d), the provider might be forced to comply with the complex regulations and licensing laws of the patient’s home country. To facilitate the internal market, the EU legislator uses this fiction to legally anchor the service at the provider’s seat instead.Footnote 9
However, because this is an exception to the general rule of physical location, the Court argues it must be interpreted narrowly. If a service requires the patient’s physical presence at any stage, the need for the fiction vanishes because the treatment is no longer happening purely “at a distance.” Consequently, for this legal fiction to be triggered, the service must be exclusively remote; any physical component brings the service back under the general rule of physical location.
2. Deconstructing “hybrid” models: the irrelevance of predominance
Building upon this narrow definition, the Court addressed the complexity of modern hybrid treatments. It determined that where a medical treatment consists of a sequence of interconnected steps, it cannot be categorised as a single telemedical act if it necessitates “healthcare provided in person” at any point simply because they are part of a broader digital treatment plan.Footnote 10 The Court clarified that the “predominance” of ICT elements is irrelevant; legal classification depends strictly on the physical or digital nature of each individual act. The Court stated that while the components shared the same therapeutic purpose, they were not so integrated as to form a single, indivisible service.Footnote 11 By maintaining this distinction, the Court ensured that traditional healthcare, implying physical examinations in the presence of the patient, remains under the national competence of the Member State of treatment, as provided by Article 168(7) TFEU.
3. Broadening the jurisdictional scope of Article 3(d)
Having demarcated the service, the Court turned to Question 1, addressing the broader applicability of the “Member State of treatment” concept. The Court confirmed that Article 3(d) of the Patients’ Rights Directive is not merely a narrow provision limited to cost reimbursement; rather, it functions as a comprehensive jurisdictional rule. This interpretation is reinforced by Article 7(7), which explicitly clarifies that cross-border healthcare may encompass services provided via telemedicine. By extension, under Article 4(1), these services must be rendered in accordance with the legislation, standards, and guidelines for quality and safety established by the Member State of treatment. In the specific context of telemedicine, this effectively anchors the regulatory oversight within the legal framework of the provider’s Member State of establishment – the “fictional” place of treatment.
For telemedicine, the Member State of treatment is the state where the provider is established, thereby solidifying the country-of-origin principle.Footnote 12 Integrating this with the E-Commerce Directive, (Question 1.3), the Court ruled that telemedicine qualifying as an Information Society Service (ISS) is anchored in the provider’s Member State – meaning German quality rules apply to the remote services provided by DrSmile, even if the patients reside in Austria.Footnote 13
4. Professional qualifications and the “physical movement” requirement
The final questions addressed the reach of national professional regulations over remote providers. Regarding Question 3, the Court ruled that the Professional Qualifications Directive, specifically Article 5(3), does not apply to telemedicine because the service involves no physical movement of the professional. The Court rejected the idea that a contractual link between a local dentist and a foreign clinic constitutes “movement” under the Directive, noting that UJ remained the recognised provider for services rendered physically in Austria.Footnote 14 Finally, addressing Question 4, the Court found that Austrian rules requiring the “direct and personal” exercise of dentistry cannot apply to remote care provided from Germany. For the in-person acts performed by UJ in Austria, the Court held that the situation was purely domestic and did not trigger the freedom to provide services under Article 56 TFEU.Footnote 15
IV. Commentary: the triumph and tensions of the country-of-origin principle
The DrSmile judgement is a masterclass in judicial tightrope walking. By anchoring telemedicine in the country-of-origin principle, the Court has provided a “digital passport” for health tech platforms, yet it has done so by slicing the medical act into fragments that may struggle to hold together in a clinical setting.
1. Legal certainty vs. clinical fragmentation: the breakdown of integrated care
The Court’s most significant contribution is its surgical definition of telemedicine. By insisting that only acts performed strictly via ICT qualify as telemedicine, the Court has provided much-needed legal scaffolding. However, this formalist victory comes at a clinical cost. Modern healthcare is increasingly blended; a treatment plan is not a series of isolated events but a continuous flow. By legally severing the physical 3D scan in Austria from the digital monitoring in Germany, the Court has created a regulatory decoupling of what is medically an indivisible process. We are left with a legal fiction where a single patient journey is governed by two different sets of national laws simultaneously. This clinical-legal gap risks creating a fragmented patient experience where the right hand of the law doesn’t know what the digital left hand is doing.
2. The “Trojan Horse” and the risk of forum shopping
The affirmation of the country-of-origin principle is undoubtedly a win for the internal market, but it invites the spectre of forum shopping. By confirming that the Member State of establishment holds the regulatory reins, the Court has effectively allowed digital platforms to “import” their preferred regulatory environment into more restrictive markets like Austria. This creates a “Trojan Horse” scenario: under the guise of the E-Commerce Directive, platforms can bypass local professional prohibitions. If a provider can establish itself in a jurisdiction with the most flexible dental oversight to serve the entire Union, the high-water marks of national healthcare protection may begin to erode under the weight of market integration.
3. The liability vacuum: who owns the digital error?
Finally, the ruling exposes a widening liability vacuum. To understand the accountability gap, one must distinguish between the two pillars of EU primary law: the freedom of establishment (Article 49 TFEU) and the freedom to provide services (Article 56 TFEU).
In national law, this distinction determines who holds the legal reins: on one hand, the freedom of establishment applies to permanent domestic activity. If a clinic is “established” in the patient’s state, it must follow all local medical, safety and liability regulations. On the other hand, the freedom to provide services allows a provider to practice temporarily or remotely from another Member State. Here, the provider largely answers to the laws of their “home” state, not the patient’s.
The liability vacuum arises because of how modern health-tech platforms split their operations between these two pillars. In the DrSmile model, the local dentist is an “established” entity (Article 49), while the digital planning centre operates under the “freedom to provide services” (Article 56) from abroad.
By categorising telemedicine strictly as a service provided at the provider’s seat, the Court reinforces this jurisdictional labyrinth. If a treatment fails, the patient is caught in a tug-of-war: the local dentist is responsible for the physical act (under local law), while the foreign platform is responsible for the digital plan (under the laws of its home state).
If a DrSmile treatment goes wrong, this division of labour, while legally neat, is a patient’s nightmare. As we move towards a multi-actor digital ecosystem, the Court’s reliance on twentieth-century establishment rules to govern twenty-first-century “liquid” business models suggests that our legal compass may need more than just a judicial recalibration; it needs a complete digital upgrade to address the direct accountability of the platform itself.
V. Conclusion: beyond judicial scaffolding
The DrSmile case represents a watershed moment for the digital internal market, offering what might be termed a defensible equilibrium between the forces of market integration and the stubborn persistence of national medical autonomy. By providing the first clear judicial map for cross-border telemedicine, the Court has moved the conversation from whether such services can exist to how they must be governed. The ruling successfully anchors digital health within the established EU legal architecture, protecting the country-of-origin principle while simultaneously throwing a lifeline to Member States by keeping physical medical acts firmly under local territorial control.
However, this victory for regulatory clarity also shines a harsh spotlight on a significant legislative gap. The triumph of the country-of-origin principle in this case serves as a poignant reminder of the recent failure of the European Health Data Space (EHDS) RegulationFootnote 16 to provide a more tailored alternative provision due to significant differences between national telemedicine regulations and resistance from Member States. The deletion of Article 8 from the final EHDS text – which originally sought to institutionalise a “country-of-destination” approach – means that the EU has retreated from legislative harmonisation just as the judiciary has finished paving the road for cross-border expansion. This leaves a landscape where the Court’s interpretation is forced to do the heavy lifting that should, by rights, belong to the EU legislature.
Ultimately, the DrSmile ruling provides the scaffolding, but not the house. While the Court has clarified the jurisdictional boundaries for digital health platforms, judicial interpretation remains a reactive tool. By adhering to a strict, binary interpretation of the Patients’ Rights Directive, the Court maintained legal certainty and avoided “judicial activism.” However, this binary approach is ill-equipped to manage the granular complexities of multi-actor clinical pathways and the resulting liability vacuums.
This suggests that the solution cannot come from the Court alone. While the judgement is legally sound under the current text of Article 3(d), it highlights an urgent need for legislative intervention. To prevent a fragmented patchwork of patients’ rights, the EU requires a unified framework specifically designed for hybrid cross-border telemedicine. Such a framework would move beyond the twentieth-century fiction of a single location of treatment and instead address the reality of liquid business models where digital planning and physical execution are inseparable.
As telemedicine transitions from a pandemic-era necessity to a structural pillar of twenty-first-century care, the clinical-legal gap identified in this case will only widen. If the promise of a truly integrated European health market is to be realised, it will require more than just landmark judgements; it will require the legislative courage to build a unified framework that is as fluid and borderless as the digital medicine it seeks to govern.
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