Innovations with Vision, Safety, and Trust
Regulation is not a barrier but a compass. Understanding legislation is essential for developing safe, effective, and trustworthy innovations in healthcare.
Legislation and Health Innovations
The healthcare sector is one of the most heavily regulated industries — and for good reason. It concerns human safety, quality of life, and the protection of fundamental human rights. For entrepreneurs developing new products or services in the field of health, understanding legislation is essential.
Without adequate legal knowledge, even the most promising solution may face insurmountable barriers to market entry, funding, or user trust.
Below is an overview of the key laws and regulations that innovators, startups, and high-tech companies in the healthcare sector should be aware of when developing their solutions.
Key Legislation for Health Sector Companies
The regulatory framework covers everything from the organisation and financing of healthcare services, the regulation of medicines and medical devices, and patients’ rights, to areas such as mental health, food safety, digital health, data management, occupational safety, long-term care, organ donation, and alternative medicine.
For entrepreneurs, the legal landscape may seem complex and intimidating at first glance, but in reality, it is essential for ensuring quality, safety, and trust in the implementation of innovations.
Understanding and complying with the right regulations significantly increases the likelihood of long-term success — for the benefit of patients, healthcare professionals, and society as a whole.
Let’s Take a Look at Some of the Key Laws (A full list of healthcare-related laws, regulations, and documents is also available below.)
Other Relevant Legal Areas Affecting Business Operations
- Patients’ Rights Act (ZPacP) – Digital applications or services that process patient data must respect privacy principles and the right to information.
- Occupational Safety and Health Act (ZVZD-1) – Important for companies developing tools and technologies for workplace health, including ergonomic and digital monitoring solutions.
- Mental Health Act (ZDZdr) – Provides the legal framework for e-mental health services and digital therapies.
- Natural Healing Remedies Act (ZNZS) – Regulates companies operating in thermal spas, wellness centres, and natural medicine.
- GDPR and the Slovenian Personal Data Protection Act (ZVOP-2) – The core legal framework for personal data protection, essential for anyone developing digital health solutions or data-based services.
ChatGPT je rekel: Key Recommendations for Entrepreneurs and Innovators
Below are the most important guidelines for anyone developing or commercialising health-related innovations within Slovenia and the EU regulatory framework.
Ensure Compliance Early in the Development Phase
Regulation is not just a final checkpoint before market entry — it is part of the entire development cycle. Innovators should engage with regulatory experts from the very beginning to ensure that their solutions are designed and tested in line with legal requirements.
Adhere to European Legislation
If your product is intended for the wider EU market, it must comply with European regulations, particularly MDR (Medical Device Regulation) and IVDR (In Vitro Diagnostic Regulation). Obtaining certification on time is essential to avoid costly delays and ensure smooth market entry.
Collaborate with Key Stakeholders
The healthcare system is complex and multi-layered. Cooperation with hospitals, regulatory bodies, patient organisations, and researchers helps develop practical, compliant, and user-centred solutions that meet real clinical needs.
Documentation and Traceability
For all regulated products — including medicines and medical devices — accurate documentation of each step (from R&D to testing and commercialisation) is a mandatory requirement for certification.