Legal Alert: Advising an AI-Powered Software as a Medical Device Developer on Clinical Investigation Agreements and Grant-Funded Innovation

Publication date: May 11, 2026

We recently advised a Polish medtech company developing an innovative artificial intelligence-powered Software as a Medical Device (SaMD) designed to support early detection of cardiovascular disease based on standard electrocardiogram (ECG) recordings.

The client is developing software that performs automated analysis of resting ECG data and generates additional diagnostic insights for physicians. While the patient experience remains identical to a standard ECG examination, the software applies advanced signal processing and AI-driven analytics to extract significantly more information from the underlying electrical activity of the heart. The current version is intended for use in clinical settings, while a next-generation solution is being developed for home use, enabling remote screening and telemedicine-based monitoring.

Grant Funding and Project Scope

The company obtained substantial non-dilutive funding under the SMART Pathway programme (Ścieżka SMART), financed through the European Funds for a Modern Economy programme and administered by the Polish Agency for Enterprise Development (PARP). The project is planned over a 36-month period and includes research and development activities, software engineering, regulatory certification, and a clinical investigation designed to validate the product’s use in home settings.

The grant financing enabled the company to expand its multidisciplinary team, including software engineers, clinicians, and regulatory specialists, and to accelerate product development and market preparation. According to the company, the funding has also created an opportunity to scale internationally following commercialization.

Why the Technology Is Innovative

The software represents a significant advancement in digital cardiology. Traditional ECG interpretation is based on a two-dimensional representation of cardiac electrical activity. By contrast, the client’s technology uses a proprietary analytical method that evaluates cardiac signals in a four-dimensional framework—capturing both spatial and temporal characteristics of myocardial activation.

The AI layer integrates this signal analysis with additional clinical data, such as patient history and supplementary diagnostic findings, to identify subtle abnormalities that may indicate elevated risk of future cardiovascular events, including myocardial infarction or heart failure.

This approach has the potential to:

• improve early detection of coronary artery disease and heart failure;
• support population-level cardiovascular screening;
• enable home-based diagnostic assessments;
• reduce pressure on healthcare systems by prioritizing high-risk patients; and
• enhance physicians’ diagnostic capabilities with automated decision support.

The company ultimately envisions a model in which patients can perform ECG tests at home using a dedicated device and smartphone application, with data transmitted to a telemedicine centre for automated analysis and clinical review.

Regulatory and Clinical Investigation Considerations

As an AI-enabled medical device intended to support clinical decision-making, the software is subject to the EU Medical Devices Regulation (EU) 2017/745 (MDR). The product is undergoing conformity assessment and certification under the current MDR framework.

A key component of the funded project is a clinical investigation involving patients who will use the software in home settings. ECG recordings will be transmitted to a collaborating medical centre, where they will be analysed using the client’s software to assess the reliability, safety, and usability of the home-use model.

Our Legal Support

We advised the client on the preparation and negotiation of the clinical investigation agreement with the healthcare institution participating in the study.

This work included legal support on:

• allocation of responsibilities between the sponsor and the investigation site;
• compliance with MDR requirements governing clinical investigations;
• patient data processing and GDPR compliance;
• ownership and use rights relating to clinical data and study results;
• confidentiality and protection of proprietary algorithms;
• insurance and liability arrangements;
• publication rights; and
• termination and post-study obligations.

Particular attention was given to the contractual treatment of software-generated data and outputs, including rights to use clinical datasets for algorithm refinement and future regulatory submissions.

Key Legal Challenges for AI-Based SaMD Companies

The project illustrates several legal issues that are increasingly relevant for AI-enabled medtech businesses:

1. Clinical Evidence Generation

AI-based software must be supported by robust clinical evidence demonstrating safety and performance. Well-structured agreements with clinical partners are essential to secure access to data and ensure regulatory compliance.

2. Data Governance

Training and validating machine-learning models requires clear legal rights to process and reuse patient data while maintaining compliance with GDPR and ethical standards.

3. Intellectual Property Protection

Clinical collaborations should safeguard ownership of proprietary algorithms, software, and derivative models, while addressing rights to jointly generated study data.

4. Grant Compliance

Projects funded through public programmes involve specific contractual obligations relating to eligible costs, milestones, reporting, and dissemination.

5. Transition to Home Use

Moving from physician-supervised use to direct-to-consumer or home-based deployment raises additional regulatory and liability considerations, including usability, cybersecurity, and telemedicine integration.

Conclusion

This engagement highlights the legal and regulatory complexity involved in bringing AI-driven Software as a Medical Device solutions to market. The combination of innovative signal analysis, artificial intelligence, telemedicine, and grant-funded R&D creates significant opportunities, but also requires careful legal structuring at every stage of development.

Our support helped the client establish a compliant contractual framework for its clinical investigation, enabling it to generate the evidence necessary to advance certification and prepare for commercialization in Poland and international markets.