What happened

The attackers supplied the security portal Zaufana Trzecia Strona with a data sample suggesting that they hold PESEL numbers (Polish national identification numbers) and at least fragments of prescription information.

To date, the company has not publicly confirmed the full scope and nature of the compromised data, referring instead to a pending forensic analysis. The investigation is being conducted by the Central Bureau for Combating Cybercrime under the supervision of the Warsaw Regional Prosecutor’s Office, and the President of the Personal Data Protection Office (UODO) has opened an inspection covering the technical and organisational measures applied and the underlying risk analysis. Since 29 August, the dataset from the incident has been available on the government portal bezpiecznedane.gov.pl, where anyone can check whether their data was affected.

The scale of the incident prompted the Ministry of Digital Affairs to announce, within three weeks, a legislative package branded the “Cyber Five”. Its key elements include certification of entities processing medical data within the existing national cybersecurity certification framework; a mandatory risk assessment before processing begins and at least every two years thereafter; new obligations for entities serving more than 100 controllers or processing data of more than 100,000 individuals (including rapid transfer of affected persons’ data to CSIRT NASK and a duty to inform client facilities about the level of their own security); and notifications of medical events via the mObywatel and mojeIKP applications. The amendments are to cover the Act on Patients’ Rights and the legislation governing the National Cybersecurity System.

Why roles in the processing chain decide everything

From a legal standpoint, the critical point is that, in relation to medical records, MyDr acts as a processor, while each facility – from a large clinic network to a single-doctor practice – remains the controller. The consequences of this structure became fully apparent after the incident:

• The obligation to notify UODO (Article 33 GDPR) and to communicate the breach to patients (Article 34 GDPR) rests with the controller, i.e. the facility. The processor is merely required to inform the controller “without undue delay” (Article 33(2) GDPR). In practice, thousands of healthcare providers had to assess risk and communicate with patients on the basis of fragmentary information from the supplier.
• Liability for damages (Article 82 GDPR) is joint and several: a patient may sue the facility, the supplier, or both. The processor is liable where it has failed to comply with obligations specifically imposed on processors by the GDPR or acted contrary to the controller’s instructions – but the facility is liable for having entrusted data to an entity that did not provide sufficient guarantees (Article 28(1) GDPR).
• Sector-specific requirements under the Act on Patients’ Rights (Article 24(4)) impose on any entity entrusted with the processing of medical records a duty of confidentiality and data security – this is precisely the provision now slated for extension to include certification and minimum technological standards.

Deputy Minister of Digital Affairs Dariusz Standerski stated openly that in this case, liability under the contract remained entirely with the controllers, i.e. small medical practices. This is the most important lesson of the incident: a data processing agreement is not a formality but the document that, on the day of a breach, determines who pays.

How a healthcare service provider can protect itself

1. The data processing agreement and the main contract as risk-allocation tools. Standard DPA templates offered by software vendors focus on satisfying the minimum requirements of Article 28(3) GDPR. A healthcare provider should negotiate further: a precise deadline and format for incident notification (e.g. 24 hours, with a defined scope of information enabling a risk assessment); audit and penetration-testing rights; an obligation to maintain specified certifications (ISO 27001 and, in future, certification under the National Cybersecurity System Act); a duty to cooperate in communications with patients and the supervisory authority; liability and recourse clauses not capped at the annual fee; and a requirement that the vendor hold cyber insurance with a defined sum insured, with the facility named as a co-insured or beneficiary.

2. Cyber and liability insurance. Standard professional liability policies for healthcare providers typically do not cover the cost of notifying patients, crisis management, administrative fines or claims arising from data breaches. A dedicated cyber policy covers these elements, but its exclusions must be read carefully: insurers increasingly condition cover on the implementation of MFA, system patching and backups, and an incident at an external supplier (a so-called third-party breach) is often covered only under an express extension. It is also worth verifying whether the software vendor’s own policy actually exists and what its limit is – given the number of facilities relying on a single system, such amounts may prove illusory.

3. A map of relationships between entities. In a real-world e-health ecosystem, patient data flows between the facility, the EMR vendor, the hosting or cloud provider, the e-prescription and e-referral operator, laboratories, IT subcontractors and billing companies. Each link is a distinct legal relationship: processing on behalf of the controller, sub-processing (Article 28(2) and (4) GDPR) or joint controllership (Article 26 GDPR). A facility should maintain an up-to-date register of these entities, know where the data is physically located and control the chain of sub-processors – a “general” consent to sub-processors without a list and without a right to object is, in practice, an abdication of control.

4. Anonymisation, pseudonymisation and data minimisation. Data that is not in the system cannot leak. Healthcare providers and vendors should separate identifiers (PESEL numbers, contact details) from clinical data, apply pseudonymisation (Article 4(5) and Article 32(1)(a) GDPR) in test, analytical and research environments, and store statistical data exclusively in anonymised form. It should be remembered that anonymisation is an irreversible process and only such a process removes data from the scope of the GDPR; pseudonymisation remains processing of personal data, but it significantly limits the consequences of a breach and is a valuable argument both in proceedings before UODO and in litigation over damages.

5. Internal obligations and incident readiness. A breach response procedure should be tested, not merely written down: who decides on notifying UODO within 72 hours, who communicates with patients, who with the media, who secures the evidence. Regular risk analysis and a data protection impact assessment (DPIA) for EMR systems – which, given their scale and the categories of data involved, almost always meet the criteria of Article 35 GDPR – is an obligation already today, and once the “Cyber Five” enters into force it will additionally become a sector-specific requirement with a prescribed frequency.

AI-enabled attacks

The healthcare sector is particularly exposed to a new generation of AI-supported attacks. Large language models enable the mass generation of credible phishing messages in flawless Polish, personalised on the basis of data from previous breaches – a PESEL number, a surname and information about a prescription are enough to construct a convincing message “from your clinic” or “from the National Health Fund”. AI tools also automate the discovery of vulnerabilities in systems and the generation of malicious code, shortening the window between disclosure of a vulnerability and its exploitation. There is a growing number of cases involving voice deepfakes used to impersonate medical staff or IT administrators in order to obtain access credentials.

For vendors and facilities, this means that traditional “don’t click suspicious links” training is no longer sufficient. Technical mechanisms are required (phishing-resistant MFA, network segmentation, AI-assisted anomaly monitoring on the defensive side), together with identity verification procedures for every request for data access or a change of permissions. Regulatory risk should also be kept in mind: AI systems deployed in healthcare facilities – including tools supporting diagnostics or triage – fall under the AI Act, and their integration with EMR systems constitutes yet another link in the processing chain that must be reflected in contracts and in the risk analysis.

How we support institutional clients

KG Legal advises healthcare providers, medical networks, telemedicine platform and e-health software vendors, and investors in this sector on managing liability for data. Our support includes auditing existing data processing agreements and IT supplier contracts for risk allocation; negotiating liability, recourse and insurance clauses; mapping the chain of processors and vetting subcontractors; preparing and testing breach response procedures; handling notifications to UODO and communications with patients; and representation in inspection proceedings and in damages litigation. For medical technology vendors, we prepare documentation and contract templates meeting the requirements of the GDPR, the Act on Patients’ Rights, NIS2 and – once enacted – the “Cyber Five” provisions, and we assess the compliance of AI-based solutions with the AI Act and the MDR. Our aim is that, on the day an incident occurs, the client knows exactly who is responsible for what and has evidence of having exercised due diligence.

Facts as at 2 September 2026, based on statements by MyDr, the Ministry of Digital Affairs and UODO, and press reports. This article is for information purposes only and does not constitute legal advice.

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Artykuł The MyDr Data Breach – Lessons for Healthcare Service Providers and e-Health Platforms pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

The development of artificial intelligence in medicine is no longer just a futuristic vision. Algorithms now support diagnostics, test result analysis, and disease prevention, and Polish medical law is beginning to address the challenges involved. The 2025 amendment to the Code of Medical Ethics explicitly addresses the use of AI by physicians for the first time, imposing obligations regarding patient information, obtaining informed consent, and the use of certified systems. However, the question arises: where does the role of technology end and the physician’s responsibility begin?

Amendment to the Code of Medical Ethics from 2025

The 2025 amendment to the Code of Medical Ethics addressed the use of artificial intelligence in medical practice for the first time in the history of Polish medical law. Because AI systems are defined as high-risk systems in the EU regulation on artificial intelligence, necessary procedural steps are identified before their practical application. The Code of Medical Ethics stipulates that four criteria must be met: informing the patient about the use of AI in the therapeutic process or when making a diagnosis; obtaining the patient’s informed consent to the use of AI. According to the AI Act, algorithms approved for medical use and holding appropriate certificates should be used. It is recommended that AI systems support physicians in their work rather than replace them. Therefore, the final decision regarding the use of AI algorithms in medicine rests with the physician. This emphasizes the need for continuous improvement in medical knowledge and the ability to adapt to new technologies.

The obligation to inform the patient that artificial intelligence will be used in the diagnosis or therapeutic process

Properly informing a patient about the use of artificial intelligence is understood as providing accurate information about the fact and characteristics of the AI system being used. This obligation also involves obtaining the patient’s informed consent to the use of AI systems, which means informing the patient about the possible benefits and risks of the proposed actions and the possibility of using other actions, as well as ensuring the patient knows and understands how the AI system being used works. Physicians should consider the circumstances and personality traits of the individual patient, ensuring that information is provided in an appropriate manner that allows for understanding the content of the message being communicated. The essence of the need for information is that AI systems are not infallible, and although the physician makes the final decision, the patient is aware of the potential risks arising from the use of AI systems. It is fundamentally crucial to respect two important patient rights: the right to information and the right to consent to healthcare services.

The obligation to obtain informed consent from the patient to use artificial intelligence in the diagnostic or therapeutic process

A written declaration of intent is not necessary to obtain patient consent; an oral statement or conduct that leaves no doubt as to the expression of intent is sufficient, although this can pose numerous evidentiary challenges in the event of a lawsuit against the doctor. If patients have been informed of the use of artificial intelligence in the diagnostic or therapeutic process, their consent to the provision of healthcare services will also include consent to the use of AI to provide these services, without the need for separate consent for the initial use of AI. When using AI systems in clinical practice, a distinction must be made between situations where the algorithm is crucial to the service being provided, for example, influencing the patient’s subsequent decisions without the doctor’s consent or with minimal consent. In such cases, informing the patient and obtaining their consent is essential. However, when algorithms merely support the doctor’s work, patient consent is not strictly required, but it is recommended to inform them about the use of AI systems.

The obligation to use artificial intelligence algorithms that are approved for medical use and have appropriate certificates

According to the AI Act, algorithms approved for medical use and with appropriate certificates must be used, given that medical practice may impact the health or life of the patient. The European system for the safety and market approval of products meeting EU requirements requires testing products using AI systems for compliance with standards and obtaining a certificate of conformity with the CE marking. Most medical software produced in the European Union requires external auditing and certification. A medical device can be software whose manufacturer has intended for use in at least one of the specific medical applications specified in the Medical Devices Regulation. The use of scientifically unverified therapeutic methods is prohibited. Software can be used for various purposes, for example, to control other medical devices, provide information that supports further therapeutic or diagnostic decisions, or assist in the interpretation of results generated by other devices.

The final diagnostic and therapeutic decision is always made by the doctor

The fourth regulation, Article 12 of the Code of Medical Ethics, aims to emphasize that artificial intelligence supports physicians in their work, rather than replaces them. Because scientific considerations about artificial intelligence are relatively new, societies still harbor many doubts about increasing the use of artificial intelligence, especially in classified high-risk systems. Furthermore, it is currently impossible for artificial intelligence to replace certain traits that physicians are capable of exercising, such as empathy and intuition.

Prospects and forecasts for the use of artificial intelligence in the work of doctors

The use of artificial intelligence in preventive medicine offers broad prospects thanks to the rapid analysis of millions of data points, which aims to enable early detection of disease. In such cases, the same conditions specified in Article 12 of the Code of Medical Ethics must be met as for treatment and diagnostic procedures. Currently, AI algorithms are increasingly equal to or even superior to qualified physicians in their preventive care. However, the novelty of the technology and the suggestion that AI is solely intended to facilitate physicians’ work contribute to many people’s skepticism about the further development of AI in preventive medicine. According to researchers, AI is ideal for preventing cardiovascular disease through remote monitoring of hypertension, and the algorithms can analyze, in addition to individual parameters, medical history, genetic predisposition, and lifestyle factors.

Legal status of Code of Medical Ethics

The Code of Medical Ethics was adopted in 1991 during the Extraordinary Second National Congress of Physicians. It is adopted and amended by the Supreme Medical Chamber. Although it is an important act for the medical profession, it does not have the status of a statute and, within the meaning of the Constitution, is not a legal act; instead, it is based on the Act on Medical Chambers. Physicians, as a professional group, have professional self-government, which influences regulations related to professional ethics. Resolutions in the Polish legal system are internal acts, regulating, among other things, the ethical principles of individual professions. The resolution addresses general ethical standards, respect for human rights, and upholding the dignity of the medical profession, which is further defined as physician conduct that does not undermine trust in the profession.

Liability for diagnostic errors of artificial intelligence systems

The dynamic development of artificial intelligence systems in medicine raises significant questions regarding liability for erroneous diagnostic or therapeutic decisions made using AI algorithms. This issue remains one of the most challenging in contemporary medical law, as current regulations do not yet provide a uniform model for liability for damages caused by AI systems.

Generally, according to Article 12 of the Code of Medical Ethics, the final diagnostic and therapeutic decision rests with the physician. This means that even when using advanced AI algorithms, the physician is not released from the obligation to exercise due diligence and critically evaluate the obtained results. If a physician thoughtlessly bases a diagnosis solely on the AI system’s indications, they may be subject to civil, professional, and in certain cases criminal liability for harm caused to the patient.

However, liability may also apply to healthcare providers, especially when the damage results from improper organization of the treatment process, the use of an uncertified AI system, or a lack of appropriate oversight procedures for the software used. The hospital or clinic is responsible for ensuring the organizational security of the healthcare services provided and for using tools that meet legal requirements and safety standards.

In certain situations, the manufacturer or supplier of an AI system may also be liable. This applies primarily to software malfunctions, design errors, improper model training, or the product’s noncompliance with the requirements of the AI Act and medical device regulations. In such cases, product liability or contractual liability provisions may apply.

Particular difficulties arise, however, when an incorrect diagnosis results from the so-called autonomous learning process of an AI system. Artificial intelligence systems lack legal personality and therefore cannot be held accountable independently. This necessitates determining which of the participants in the process – the doctor, the medical facility, the manufacturer, or the technology provider – actually contributed to the damage.

The doctrine emphasizes that with the further development of artificial intelligence, it will be necessary to create clearer regulations regarding liability for damage caused by AI systems in healthcare. The current legal framework relies primarily on the application of provisions analogous to traditional medical liability and product liability.

Other legal acts supplementing the issues of artificial intelligence in medicine

Act on Patients’ Rights and the Patient Ombudsman

The 2008 Act on Patients’ Rights and the Patient Ombudsman contains regulations complementary to the Code of Medical Ethics, but without addressing the topic of artificial intelligence. Patients have the right to information regarding, among other things, diagnosis, proposed diagnostic and treatment methods, and the foreseeable consequences of their use or omission, as well as the right to information about the type and scope of healthcare services provided by the healthcare provider.

Act on the Professions of Physician and Dentist

The 1996 Act on the Profession of Physicians and Dentists regulates the obligation to practice the profession in accordance with current medical knowledge, available methods and means of preventing, diagnosing, and treating diseases, in accordance with the principles of professional ethics, and with due diligence. In the case of the use of artificial intelligence in medicine as a high-risk system, this means the obligation, stipulated in the KEL, to use certified and approved systems.

Other legal acts relating to the issue of artificial intelligence in medicine

Because the field of artificial intelligence is a relatively new field of study and few legal acts have been created to date to regulate its operation, the vast majority of clinic and hospital regulations still do not directly address the use of artificial intelligence systems in healthcare services. However, indirect references can be found, such as specifying the institution’s purpose as, among other things, teaching and research activities in connection with the provision of healthcare services and health promotion, including the implementation of new treatment methods and medical technologies, which include artificial intelligence systems.

Summary

The dynamic development of artificial intelligence in healthcare means that existing legal regulations may prove insufficient in the coming years. Developing clear rules of accountability for AI-supported decisions and maintaining a balance between innovation and patient safety will be crucial. Despite technological advances, humans – physicians – should continue to play a central role in the diagnostic and therapeutic process, bearing responsibility for the patient’s well-being.

Artykuł Can AI Diagnose Patients? Medical Law and the Artificial Intelligence Revolution pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.

Biostimulants in aesthetic medicine – current regulatory challenges for manufacturers, distributors and clinics

The aesthetic medicine market is currently one of the fastest-growing healthcare segments in Europe. Particularly dynamic growth is observed in so-called tissue biostimulants, preparations used to stimulate the body’s natural regenerative processes. While traditional fillers dominated just a few years ago, today both manufacturers and physicians are increasingly turning to preparations containing poly-L-lactic acid (PLLA), calcium hydroxyapatite, polynucleotides, and collagen preparations, whose mechanism of action is based on the stimulation of tissue regeneration processes rather than solely on mechanical effects.

The growing popularity of these products, however, raises a number of legal questions. These concern not only their qualification as medical devices, but primarily the manner of communicating their properties and permissible forms of promotion. In practice, manufacturers, importers, distributors, and aesthetic medicine clinics increasingly face the dilemma of drawing the line between providing reliable product information and advertising, which is subject to stringent legal restrictions.

This issue has become particularly important following the entry into force of the Act of April 7, 2022, on Medical Devices and the issuance of the Regulation of the Minister of Health on the Advertising of Medical Devices. Polish legislators have decided to introduce some of the most detailed regulations regarding the advertising of medical devices in Europe. These restrictions directly impact the activities of manufacturers, distributors, importers, healthcare providers, and marketing agencies serving the aesthetic medicine industry.

At the same time, it’s important to remember that advertising medical devices does not operate in isolation from other legal regulations. Businesses must consider not only the provisions of Regulation (EU) 2017/745 on medical devices (MDR) and the Medical Devices Act, but also regulations on consumer protection, combating unfair market practices, combating unfair competition, personal data protection, and sometimes regulations governing the practice of medical professions and healthcare activities. Consequently, a single marketing campaign may be subject to simultaneous assessment under several different legal regimes.

Particular difficulties arise with products used exclusively by individuals with appropriate professional qualifications. In practice, most biostimulants are administered via injection by a physician or other qualified medical professional. This raises the question of whether products intended exclusively for professional use can be advertised at all, and if not, how can businesses legally present information about their offerings on websites, social media, or at industry conferences.

The purpose of this study is to present practical aspects of applying regulations regarding the advertising of medical devices, using tissue biostimulants as an example. Particular attention will be paid to the boundary between advertising and information, the obligations of manufacturers and distributors, the most common marketing errors, and compliance solutions that can reduce the risk of violating applicable regulations.

Biostimulants – why do they raise so much legal controversy?

From a legal perspective, biostimulants constitute one of the most interesting categories of medical devices. Their specificity lies in the fact that, although formally subject to regulations specific to medical devices, their method of use, risk profile, and patient perception often resemble medicinal products more than traditional medical devices.

In market practice, patients often fail to recognize the difference between a medicinal product and a biostimulant. Both types of products are administered in a doctor’s office, require medical qualifications, involve intervention in the body, and may cause adverse reactions. Therefore, for the average consumer, the difference between a medicinal product and a medical device remains almost invisible.

From the perspective of EU law, however, what matters most is not the method of administration or the site of use, but the mechanism by which the principal intended action is achieved. The MDR is based on a fundamental distinction between medicinal products and medical devices. If the principal action is achieved by pharmacological, immunological, or metabolic means, the product will generally be classified as a medicinal product. However, if the mechanism of action is based on other properties – for example, physical or mechanical – the product may be classified as a medical device, even if its use leads to long-term biological effects.

This very boundary has been the subject of numerous interpretational disputes for years. In the case of biostimulants, the preparation does not replace natural processes occurring in the body nor does it produce a therapeutic effect through a pharmacological mechanism. Its purpose is to create conditions enabling the activation of natural regenerative processes, such as stimulating fibroblasts to produce collagen or rebuilding the extracellular matrix. It is this mechanism that causes most currently available biostimulants to be classified as medical devices.

This does not mean, however, that all products marketed as “biostimulants” automatically fall into the same regulatory category. Legal classification is determined by a case-by-case analysis of the specific product, its intended use, and the mechanism of action specified by the manufacturer. In practice, there are also products that, despite similar aesthetic applications, may be subject to different legal regimes, including regulations concerning medicinal products, cosmetics, and medical devices.

This is fundamental for subsequent marketing communications. Already at the product qualification stage, the manufacturer should consider the target audience, the information that can be conveyed to recipients, and the advertising restrictions that will apply. Mistakes made at this stage often result in the need to redesign the entire marketing strategy after the product has been launched.

Can biostimulants be advertised? Limitations under the Medical Devices Act and the MDR Regulation

One of the most frequently asked questions by manufacturers, importers, and healthcare providers is whether biostimulants can be advertised to a broad audience. The answer to this question is ambiguous and requires consideration of both the provisions of the EU MDR Regulation, the Polish Medical Devices Act, and implementing regulations governing advertising.

In practice, a certain pattern can be observed. Many entrepreneurs equate the fact that a product has been legally introduced to the market with the ability to freely promote it. However, this assumption is incorrect. Approval of a medical device for marketing does not automatically mean that the manufacturer or distributor can use any marketing tools. On the contrary, the more specialized the product and the greater the risk associated with its use, the greater the restrictions on its communication.

In the case of biostimulants, it is particularly important that the vast majority of these products are intended for use only by individuals with appropriate professional qualifications. Treatments using them require medical qualification, maintaining appropriate aseptic conditions, and injections performed in accordance with medical knowledge. Therefore, the recipient of the product is not the patient, but a medical professional who then uses the product while providing healthcare services or aesthetic medicine treatments.

This circumstance is of fundamental importance from the perspective of advertising law.

Advertising of medical devices is not advertising of consumer products.

The Medical Devices Act adopts different assumptions than the regulations governing the advertising of ordinary consumer goods. The legislator’s goal was not to create freedom in marketing activities, but to ensure that decisions regarding the use of medical devices are made primarily based on medical knowledge, not advertising messages.

For this reason, the legislator decided to introduce numerous restrictions on both the content of advertising and its target audience. In practice, this means that, already at the design stage of a marketing campaign, entrepreneurs should answer three fundamental questions:

• who is the actual user of the product,
• to whom the message is addressed,
• whether the information provided is of a promotional nature or purely informational.

Only a combined analysis of these elements allows us to assess the compliance of the planned communication with applicable regulations.

The intended use of the product is crucial.

In practice, there’s a common misconception that advertising opportunities are determined solely by how a product is sold. This isn’t the correct approach.

The manufacturer’s intended use of the product and the user group specified in the technical documentation and instructions for use are of much greater importance. If the manufacturer has specified that the product should only be used by professionals, this also influences the assessment of the admissibility of directing marketing messages to individuals without medical qualifications.

This is precisely the situation with most biostimulants. These products are intended for procedures requiring appropriate professional training, knowledge of anatomy, aseptic techniques, and the ability to recognize contraindications. From a regulatory perspective, it would be difficult to justify extensive advertising campaigns aimed at the general public when the product itself cannot be used independently by the average consumer.

This doesn’t mean, however, that businesses cannot provide any information regarding such products. On the contrary, the law permits the provision of information about medical devices, but the line between information and advertising requires individual assessment.

Advertising and information – why is the distinction so important?

In practice, the vast majority of disputes concerning medical device advertising do not focus on obvious promotional campaigns. Much more often, the problem arises with materials that businesses define as “informational,” while from the perspective of regulatory authorities, they may be considered advertising.

Importantly, neither the MDR nor the Medical Devices Act provide a legal definition of medical device advertising. However, the lack of a statutory definition does not imply any freedom of interpretation. Case law and doctrine assume that the nature of a message is primarily determined by its actual purpose, not the name given to it by the trader.

If the primary purpose of the message is to increase interest in the product, build a positive image of the product or encourage its purchase or use, there is a high probability that the message will be classified as advertising, regardless of whether it contains a direct call to purchase.

In practice, this means that even seemingly neutral materials may be considered advertising if they are prepared in a way that highlights only the advantages of the product, ignores its limitations or uses characteristic marketing techniques.

Is the manufacturer’s website itself an advertisement?

This is one of the most frequently asked questions in the practice of law firms advising manufacturers of medical devices.

There is no single universal answer to this question.

The mere presence of product information on a website does not constitute advertising. A website can function as a product catalog, a database of technical documentation, or a platform for communicating with medical professionals. However, if the product’s presentation goes beyond providing objective information and begins to utilize typical marketing mechanisms, the risk of such communication being classified as advertising significantly increases.

For example, posting instructions for use, declarations of conformity, technical data, or information on how to use a product on a website will generally be informative. However, a situation in which the same website includes slogans such as “revolutionary rejuvenation method,” “the most effective biostimulator available on the market,” “instant lifting effect,” or “spectacular results guaranteed” should be assessed differently. In such cases, the message goes beyond neutral information and begins to serve a promotional purpose.

Therefore, designing websites for medical device manufacturers requires close collaboration between marketing departments and legal and regulatory affairs departments . In practice, even seemingly minor changes in product presentation can result in a different legal classification for the entire message.

The boundary between advertising and information – practical problems of producers and aesthetic medicine clinics

While the distinction between advertising and information seems intuitive, in practice it is one of the most problematic issues related to the functioning of the medical device market. This stems primarily from the fact that contemporary marketing communication rarely takes the form of classic television or print advertising. Businesses much more frequently utilize websites, social media, newsletters, podcasts, webinars , expert blogs, and educational materials. Each of these forms can—depending on how it is prepared—be considered both neutral information and advertising.

In practice, there is no single element that automatically determines the classification of a given message. Supervisory authorities and courts analyze all the circumstances, taking into account the content of the message, its form, presentation, audience, and the actual purpose of the publication. This means that even a message containing only truthful information may be considered advertising if its primary purpose is to encourage the purchase or use of a product.

For this reason, businesses should move away from the simple question: “Are we allowed to publish this information?” and instead ask themselves: “How will the average recipient perceive this message?” It is the recipient’s perspective, not the business’s intention, that will in many cases determine the legality of the message.

Website – an entrepreneur’s business card or an advertising tool?

The first place where doubts arise is almost always the manufacturer’s, distributor’s, or clinic’s website. For many businesses, it is their primary channel of communication with the market, yet it is also one of the most frequently scrutinized elements during inspections conducted by regulatory authorities.

The mere presence of information about a medical device on a website is not prohibited. Businesses have the right to present information about the products offered, their properties, methods of use, technical documentation, and instructions for use. However, problems arise when the presentation method goes beyond providing objective information.

A good example is comparing two descriptions of the same product.

The first one could be as follows:

“A preparation intended for the reconstruction of tissue volume in accordance with the instructions for use. The product is intended for use by qualified medical professionals.”

This description is for informational purposes only. It is limited to presenting the product’s intended use and user group.

The following message should be assessed differently:

“The most innovative biostimulator on the market. It instantly rejuvenates the skin and provides a spectacular lifting effect after just one treatment.”

Although both messages refer to the same product, the second employs typical marketing tactics. It uses evaluative terms (“the most innovative,” “spectacular effect”), promises of effectiveness, and suggests a competitive advantage. This type of message is difficult to consider as neutral technical information.

In practice, this means that entrepreneurs should analyze not only the content of the information, but also the way it is expressed. Often, it is individual marketing terms that determine the overall nature of the message.

Newsletters and mailings to customers

Another tool increasingly used by manufacturers and distributors is newsletters and emails directed to customers. Again, not every message can be considered advertising.

If a newsletter contains information about changes in regulations, new regulatory requirements, announcements from supervisory authorities, or changes to product instructions, it will generally serve an informative purpose. However, messages whose primary purpose is to increase sales of a specific product should be assessed differently.

For example, a message titled “Changes to MDR requirements for technical documentation” would be educational in nature. An email with the slogan “Discover the most effective biostimulant available on the market – order today” would undoubtedly serve an advertising function.

This does not, of course, prohibit commercial communication. However, entrepreneurs should remember that such communication is subject to all restrictions applicable to advertising medical devices.

Webinars and training – education or product promotion?

The significant increase in the popularity of webinars organized by medical device manufacturers has also led to this form of communication starting to attract the attention of supervisory authorities.

Organizing training for doctors and other medical professionals is nothing unusual. On the contrary, in many cases, proper user training is an essential element in ensuring the safe use of a device.

The problem arises, however, when a webinar described as a “scientific training” actually focuses almost exclusively on promoting one product, highlighting its advantages while omitting limitations, contraindications, and alternative methods of treatment.

In practice, it is worth adopting the principle that the more educational the material is, the greater the emphasis should be on presenting objective medical knowledge, and not only information beneficial to the manufacturer.

Scientific conferences

Similar problems apply to industry conferences. Sponsorship of scientific events by medical device manufacturers is common practice and raises no objections in itself. However, risks arise when the scientific component is subordinated to marketing objectives.

In practice, particular caution should be exercised when presenting research results for a specific product. Results should be presented honestly, taking into account methodological limitations and the full clinical context. Selectively presenting only favorable data may be viewed as misleading.

LinkedIn – professional communication can also be advertising

Many content creators assume that since LinkedIn is primarily a professional platform, the content published there is strictly business-related. However, this assumption is far-fetched.

If a LinkedIn entry is limited to information about participation in a conference, obtaining a certificate, a scientific publication or organizational changes in the company, it is generally difficult to attribute an advertising nature to it.

However, if a publication contains incentives to use a specific product, comparisons with competitive products, promises of specific clinical effects or highlights the advantages of a product in order to increase sales, it may be considered advertising, regardless of the fact that it was published on a professional website.

LinkedIn is increasingly being used as a marketing platform for the healthcare market. Therefore, communications conducted via this platform should also be subject to the company’s internal compliance procedures.

Social media – the biggest challenge for the biostimulant market

Social media has completely transformed the way patients make decisions. Just a dozen or so years ago, the primary source of information was a doctor’s consultation and manufacturer-provided materials. Today, many patients primarily seek information on Instagram, TikTok, Facebook, and YouTube, guided by the opinions of influencers , physicians with educational profiles, and other users’ testimonials.

For entrepreneurs, this represents a huge marketing opportunity, but also significant regulatory risk. Traditional regulations regarding medical device advertising were designed with press, radio, and television advertising in mind. Modern online communication is much more dynamic and often combines elements of education, personal branding, and product promotion. As a result, assessing the legality of a specific message requires a case-by-case analysis of its actual purpose and context.

Instagram – where does education end and advertising begin?

Instagram remains the most important communication channel used by aesthetic medicine clinics and physicians performing biostimulant treatments. This platform relies primarily on visual communication, which inherently has a stronger impact on audiences than traditional product descriptions.

From a legal perspective, however, it cannot be assumed that every post about a procedure constitutes advertising. Physicians have the right to conduct educational activities, explain the mechanisms of individual procedures, discuss indications and contraindications, and comment on scientific publications. Such activities contribute to increasing patient awareness and should not, in and of themselves, be equated with advertising.

The line is crossed when communication begins to focus on promoting a specific medical device or building its commercial appeal. This applies particularly to publications containing marketing slogans, incentives for procedures, information about price promotions, comparisons with competing products, or emphasizing the exceptional effectiveness of a specific product without providing the full medical context.

In practice, it is worth adopting the rule that the more a post resembles advertising material prepared by a marketing agency, the greater the risk of it being classified as an advertisement for a medical device.

TikTok – short form does not exempt from responsibility

Just a few years ago, few medical device manufacturers considered TikTok a business communication tool. Today, the situation is completely different. More and more clinics are publishing short videos demonstrating treatment procedures, patient reactions, and the aesthetic effects achieved after using specific products.

The specific nature of this platform, however, means that the message is necessarily simplified. A video lasting several dozen seconds rarely allows for the presentation of contraindications, possible side effects, or limitations of the product’s use. As a result, there is an increased risk of creating a one-sided image of the product, highlighting only its benefits.

From a compliance perspective , businesses should therefore exercise particular caution when preparing materials published on platforms based on short audiovisual forms. Merely shortening the message does not exempt them from ensuring its compliance with regulations on advertising medical devices.

Influencer Marketing – New Regulatory Risk

influencers remains one of the most dynamically developing areas of marketing. This phenomenon has also impacted the aesthetic medicine market. Increasingly, individuals with significant social media followings are publishing treatment reports, presenting their recovery processes, and describing their own experiences using specific products.

From a legal perspective, such collaboration requires special caution. Even if the influencer doesn’t mention a specific product, the way the treatment is presented can lead to increased interest in a specific technology or manufacturer. If the publication is created as part of a commercial collaboration, additional obligations arise under regulations regarding labeling advertising content and consumer protection.

In practice, the producer should remember that responsibility for the legality of the message is not always limited solely to the influencer. Depending on the cooperation model, the entrepreneur initiating the campaign may also be responsible for the manner in which marketing communications are conducted.

Doctor as a product ambassador

The use of physicians’ authority to promote medical products remains a particularly sensitive issue. Public trust in medical professionals means their statements have a much greater impact than traditional advertising messages.

This doesn’t mean, however, that doctors cannot publicly comment on the technologies they use. On the contrary, sharing medical knowledge, clinical experience, and research results is a crucial element in the development of medical science and practice. The problem arises only when a doctor’s statement ceases to be expert-based and begins to serve a marketing function.

The risk increases especially when a physician appears in manufacturer-produced materials, uses promotional language, or explicitly encourages consumers to choose a specific product. In such cases, the regulatory authority may determine that the use of the medical profession’s authority serves to increase the product’s commercial appeal, which requires assessment from the perspective of regulations governing the advertising of medical devices.

Before – after photos – an effective marketing tool or a source of risk?

One of the most distinctive elements of communication in aesthetic medicine is photographs depicting the patient’s appearance before and after the procedure. From a marketing perspective, this is an extremely effective tool for influencing potential clients. However, from a legal perspective, its use raises a number of concerns.

Firstly, such materials often lead the recipient to believe that the treatment will provide a guaranteed result. However, the results of medical procedures depend on numerous individual factors, such as the patient’s health, age, biological predispositions, and adherence to post-treatment recommendations . Presenting single, spectacular results can lead to unrealistic expectations.

Secondly, publishing patient photos requires compliance with regulations on personal data protection and the protection of personal rights. Consent to perform a procedure does not constitute consent to the dissemination of the image. The provider should obtain separate, informed, and voluntary consent covering the publication of photographs in specific communication channels.

Third, it’s important to remember that even properly obtained patient consent doesn’t eliminate the risk of a publication being considered an advertisement for a medical device. If a photo is used to promote a specific product or increase interest in a specific procedure, the entire message should be assessed in light of advertising regulations.

In practice, this means that the use of ” before – after ” photography requires simultaneous analysis from the perspective of medical device law, personal data protection, civil law, and consumer protection regulations. Failure to consider even one of these aspects can lead to significant legal risk.

Misleading advertising – why can a truthful message also violate the law?

One of the most common mistakes made by businesses operating in the medical device market is the belief that because all information contained in an advertisement is truthful, the message is automatically legal. However, this assumption is far-fetched and is not supported by either the EU MDR or national regulations regarding medical device advertising.

Assessing the legality of advertising is not limited to verifying the veracity of individual claims. Equally important are the manner in which they are presented, the context of the overall message, and the potential impact on the recipient’s decisions. Advertising can be misleading not only by providing false information, but also by selectively presenting facts, omitting important limitations, or emphasizing only the positive aspects of a product’s use.

This is why Article 7 of the MDR should be considered one of the key regulations governing the marketing communications of medical device manufacturers. This provision prohibits the use of texts, names, trademarks, images, symbols, or other markings that could mislead the user or patient regarding the intended purpose, safety, or performance of the device. This prohibition applies not only to labels and instructions for use but also to advertising materials and other forms of market communication.

In practice, this means that an entrepreneur should analyze each message not only in terms of compliance with the product’s technical documentation, but also from the perspective of how the average recipient might interpret the information presented.

Not only falsehood, but also silence

One of the most frequently underestimated aspects of advertising is the responsibility for omitting information that is important to the recipient. Businesses typically focus on avoiding false claims, much less on analyzing the consequences of omitting specific information.

Imagine an advertisement for a biostimulator in which the manufacturer presents excellent aesthetic results achieved after the treatment. All photographs are authentic, and the description of the effects reflects the actual experiences of selected patients. At the same time, the advertisement contains no information about the need for medical qualification, possible contraindications, the risk of side effects, or the body’s varied response to treatment.

Formally, none of the claims presented are false. Nevertheless, the recipient may be misled into thinking that achieving the presented effect is typical, predictable, and practically guaranteed. Consequently, the message may be considered misleading because it creates unrealistic expectations regarding the product’s performance.

A similar risk arises when using terms such as “safe,” “non-invasive,” “natural,” or “side-effect-free.” Even if a product has a high safety profile, using such phrases can imply an absence of risk, which is difficult to reconcile with clinical reality.

Can we use the terms “best”, “most effective” or “revolutionary”?

Marketing language often relies on the use of evaluative terms. Advertisements feature phrases such as “market leader,” “the most innovative product,” “the best rejuvenation technology,” or “a breakthrough in aesthetic medicine.” In the consumer goods sector, this type of communication is common. However, when it comes to medical devices, much greater caution is required.

First, an entrepreneur should have objective evidence to support any comparative or evaluative claim. Second, even the existence of scientific research does not always justify the use of terms suggesting absolute superiority over all competing solutions. In medical practice, the effectiveness of therapy depends on many factors, including the patient’s qualifications, the physician’s experience, and individual biological conditions.

From a compliance perspective, a much safer solution is to use a description based on clinical trial results and technical parameters of the product, instead of using general marketing slogans.

Practice of supervisory authorities – the growing importance of digital communication

Recent years have seen a significant increase in supervisory authorities’ interest in online communications. While previously, oversight activities focused primarily on traditional advertising materials, they now also analyze websites, social media profiles, newsletters, videos published on streaming platforms , and collaborations with influencers.

This trend is consistent with a broader trend observed at the EU level, where increasing emphasis is being placed on countering manipulative marketing practices and ensuring a high level of protection for consumers using healthcare services. Consequently, businesses should assume that online communications are subject to the same scrutiny as traditional forms of advertising.

The Polish Office of Competition and Consumer Protection and consumer protection – the second pillar of responsibility

Although the primary legislation regulating the advertising of medical devices remains the Medical Devices Act, businesses cannot limit their analysis solely to this legal regime. Consumer protection regulations also apply, in particular the Act on Combating Unfair Market Practices and the Act on Competition and Consumer Protection.

From the perspective of the President of the Office of Competition and Consumer Protection (UOKiK), the impact of a message on the average consumer is of particular importance. If a communication exploits emotions, raises unjustified expectations, or suggests characteristics that the recipient is unable to independently verify, it may be considered a practice that violates the collective interests of consumers.

In practice, this means that a single marketing campaign may be assessed simultaneously by different authorities under different legal frameworks. Manufacturers should therefore design their marketing activities to ensure compliance not only with medical device regulations but also with consumer protection and fair competition regulations.

Compliance instead of reaction after inspection

Experience in recent years shows that a significant number of violations are not the result of deliberate actions by businesses, but rather a lack of appropriate internal procedures. Marketing materials are often prepared by external advertising agencies that are intimately familiar with the mechanisms of selling consumer products but lack experience in the regulated sector.

compliance systems that encompass the entire marketing communications process is becoming increasingly important . Every piece of content – whether it’s an Instagram post, a product brochure, a webinar , or a YouTube video – should be reviewed not only by the marketing department but also by those responsible for regulatory and legal matters.

This approach allows for the identification of risks before the material is published, reducing the likelihood of initiating administrative proceedings, disputes with supervisory authorities and negative image consequences.

The most common mistakes of manufacturers, importers, distributors and clinics – what to avoid in practice?

Recent experience shows that most violations of regulations regarding medical device advertising do not result from deliberate disregard for applicable regulations. Quite the opposite – entrepreneurs operating in the aesthetic medicine market typically strive to conduct their business in compliance with the law, but they encounter difficulties resulting from ambiguous regulations and the dynamic development of modern communication channels. Marketing of medical products is increasingly conducted via social media, educational platforms, and industry events, whereas existing regulations were primarily designed with traditional forms of advertising in mind.

In practice, however, there are several recurring mistakes that occur regardless of the size of the company and which should be taken into account when designing a marketing strategy.

Mistake No. 1 – Equating commercial information with neutral information

One of the most common misconceptions is that material doesn’t constitute advertising solely because a business owner has designated it as “information.” This approach is unsupported by applicable law.

The nature of a message is assessed based on its actual function, not the name given by the author. If the material highlights the benefits of a specific product, builds its market appeal, or is intended to encourage the recipient to choose a specific product, there is a high probability that it will be classified as an advertisement, even if it does not contain a classic call to purchase.

An example would be an article published on the manufacturer’s website titled “Modern Skin Regeneration Possibilities.” If the majority of the text is devoted to a single product, highlights its advantages over the competition, and leads to a contact form allowing purchase of the product or registration for training, it’s difficult to consider such material solely educational.

In practice, entrepreneurs should remember that supervisory authorities analyze not only the content of the publication, but also its location, method of presentation and connection with the entrepreneur’s business activity.

Mistake #2 – Copying Cosmetic Product Marketing

The aesthetic medicine market is developing in parallel with the cosmetics market, resulting in many marketing activities being mutually inspired. However, from a regulatory perspective, this approach can lead to serious problems.

Cosmetics marketing relies primarily on building emotions, visual appeal, and creating a specific lifestyle. Meanwhile, communication regarding medical devices is subject to much more stringent requirements. Using identical marketing techniques for products covered by the MDR may lead to violations of advertising regulations, especially if the message ignores the limitations imposed by the product’s intended use or its method of use.

In practice, this means that the marketing department of a medical device manufacturer should not automatically use solutions used in cosmetic campaigns, even if they seem effective from a business point of view.

Mistake No. 3 – overexposing the effects of the treatment

Marketing materials for biostimulants often focus almost exclusively on aesthetic effects. Images depicting wrinkle smoothing, facial contour improvement, or increased skin firmness undoubtedly attract audiences and enhance the message’s appeal.

The problem, however, is that the results of aesthetic medicine treatments are individual. They depend on the patient’s age, health, skin condition, previous medical procedures, lifestyle, and the experience of the practitioner. Presenting individual, exceptionally positive results without proper context can lead to unrealistic expectations on the part of potential patients.

From a compliance perspective , it is much safer to present information about the mechanism of action of the product and its intended use than to focus all communication on spectacular visual effects.

Mistake No. 4 – Ignoring contraindications and limitations of use

Another common mistake is presenting a product solely through the lens of its benefits. Marketing materials often emphasize the product’s effectiveness, innovation, and safety, while failing to mention situations in which its use may be inadvisable.

Meanwhile, reliable communication regarding medical devices should also include information about contraindications, limitations of use, and the need for medical qualification. This doesn’t mean, of course, that every advertisement must include full instructions for use, but omitting all information regarding potential risks could lead to accusations of misleading consumers.

Mistake #5 – Lack of cooperation between marketing and legal departments

In many companies, marketing materials are prepared by external creative agencies or marketing departments that lack specialized knowledge of medical device regulations. Only then does the completed material reach the legal department, often just prior to publication.

affairs specialists and lawyers at the marketing campaign design stage. This avoids the need for later material withdrawal or costly modification.

Mistake #6 – Lack of social media procedures

Many companies have extensive procedures for approving product catalogs and printed materials, yet they don’t regulate the rules for publishing content on social media. Yet, it’s short posts on Instagram, Facebook, and LinkedIn that are currently published most frequently and have the greatest impact on a company’s image.

The lack of internal guidelines leads individual employees to publish content at their own discretion, often unaware of the legal consequences of using specific phrases or photographs. In practice, it’s worth developing separate policies for online communication, covering topics such as product presentation, use of photographic materials, publishing coverage of industry events, and collaborating with physicians and influencers.

Compliance practices – how to organize legal marketing communications?

Compliance system shouldn’t be limited to merely responding to emerging issues. Its primary goal is to prevent violations by establishing transparent rules for preparing and approving marketing materials.

In practice, a growing number of medical device manufacturers are implementing multi-stage approval procedures involving marketing departments, regulatory affairs specialists, quality control departments, and lawyers. This model allows for the assessment of a material not only in terms of its marketing appeal but also its compliance with the product’s technical documentation, instructions for use, and applicable regulations.

Maintaining documentation of the approval process is also particularly important. In the event of an audit, the company should be able to demonstrate that the materials were prepared in accordance with internal procedures and reviewed by appropriately qualified individuals. Archiving subsequent versions of materials, legal opinions, and publication decisions can be of significant evidentiary value.

In practice, a well-functioning compliance system shouldn’t be perceived as an obstacle to marketing activities. On the contrary, properly designed procedures enable legally secure communication, reducing the risk of administrative sanctions and disputes with supervisory authorities, while building trust with customers and business partners.

European perspective – why will the importance of compliance systematically grow?

Polish regulations on medical device advertising are currently among the most detailed in the European Union. However, this does not mean that businesses operating in the domestic market can limit themselves solely to knowledge of the provisions of the Medical Devices Act and the Regulation of the Minister of Health. The functioning of the medical devices market is increasingly determined by the practice of applying the MDR, the positions of EU bodies, and the actions of national regulatory authorities in individual member states.

The MDR does not contain comprehensive regulations on the advertising of medical devices. It focuses primarily on product safety, manufacturers’ obligations, conformity assessment, and the rules for placing devices on the market. At the same time, Article 7 of the MDR establishes the general principle that all communication about a device – regardless of its form – must not mislead users or patients about the product’s intended purpose, properties, safety, or efficacy.

In practice, this provision serves a much broader purpose than the classic ban on misleading advertising. It constitutes a specific interpretative principle that should be considered when assessing every form of communication conducted by a manufacturer or distributor. Increasingly, supervisory authorities are moving away from formalistic analysis of individual advertising slogans and focusing on the overall perception of the message by the average user.

At the same time, the activities of Medical Device Coordination Group (MDCG) highlights the growing importance of transparent information provided to users of medical devices. Although MDCG documents are not legally binding, in practice they guide the interpretation of MDR provisions by national authorities and notified bodies. Increasing emphasis is being placed on ensuring consistency between a device’s technical documentation, instructions for use, and market communications.

It can be predicted that in the coming years, marketing control will encompass not only traditional advertising but also recommendation algorithms of online platforms, message personalization, the use of artificial intelligence in marketing, and automated advertising profiles. The development of new technologies is blurring the lines between information, advertising, and educational content.

For manufacturers, this means moving away from a one-time approach to assessing marketing materials. Implementing ongoing compliance procedures that enable ongoing assessment of communications’ compliance with rapidly evolving regulatory requirements will be much more effective.

Practical checklist compliance before publishing marketing materials

In practice, most violations can be avoided by implementing simple verification procedures. Before publishing material regarding a medical device, it’s important to answer the following questions:

First, is the product intended for use by laypeople or exclusively by professionals? The answer to this question determines the acceptable scope of communication and the target audience.

Secondly, is the planned material truly informative, or is its primary purpose to increase interest in the product? When in doubt, it’s worth adopting a more cautious approach and evaluating the message according to advertising principles.

Third, are all claims regarding product properties supported by technical documentation, instructions for use, and conformity assessment results? Marketing departments should not independently make new claims regarding product effectiveness or safety.

Fourthly, does the material use evaluative terms such as “best”, “most effective”, “revolutionary” or “guaranteed effect”, the validity of which could be questioned by the supervisory authority?

Fifth, does the message include product use restrictions, the need for medical qualification, and other information relevant to user safety?

Sixth, does the publication contain photographs or recordings of patients? If so, it is necessary to verify not only compliance with regulations on advertising medical devices, but also the basis for processing personal data, the scope of consent granted, and the protection of personal rights.

Seventh, was the material reviewed by those responsible for regulatory and legal matters? In practice, even minor linguistic changes can significantly alter the legal assessment of the entire message.

Eighth, does the entrepreneur have documentation confirming the material approval process? In the event of an audit, the ability to demonstrate organizational diligence can be crucial to assessing the entrepreneur’s actions.

Summary

The development of the biostimulator market is one of the most dynamic areas in contemporary aesthetic medicine. These products respond to growing patient expectations for natural tissue regeneration methods, while simultaneously posing entirely new regulatory challenges for manufacturers, importers, distributors, and healthcare providers.

Contrary to popular belief, the biggest problem today isn’t the mere ability to advertise. The key challenge remains the ability to communicate effectively, while simultaneously providing accurate product information and complying with stringent legal requirements. The line between information and advertising is becoming increasingly blurred, especially in the digital environment, where communication occurs via social media, educational platforms, and artificial intelligence tools.

From the perspective of entrepreneurs, this means a shift in thinking about medical device marketing. Instead of treating compliance as a final stage of reviewing advertising materials, it’s worth viewing them as an integral element of the process of designing market communication. Early involvement of legal, regulatory, and quality specialists not only reduces the risk of administrative sanctions but also builds brand credibility and audience trust.

It can be expected that the requirements for communication transparency will systematically increase in the coming years. The development of artificial intelligence, data-driven marketing, and message personalization will force supervisory authorities to increasingly scrutinize not only the content of advertisements but also their distribution and impact on audience decisions. In this environment, competitive advantage will be achieved not by those businesses that conduct the most aggressive marketing communications, but by those that manage to combine innovation with regulatory responsibility.

Artykuł Biostimulants under the microscope of the law – where does information end and prohibited advertising of medical devices begin? pochodzi z serwisu KIELTYKA GLADKOWSKI LEGAL | CROSS BORDER POLISH LAW FIRM RANKED IN THE LEGAL 500 EMEA SINCE 2019.