HealthTech and BioTech

Other IT Law areas of expertise:

The industries of medicine, life sciences, and healthcare are among the most strictly regulated in the world, because these fields directly affect human life and health. For that reason, the responsibility borne by companies that develop and market innovations and products is immense.

Nevertheless, despite complex rules and requirements, healthtech and biotech are seeing rapid growth thanks to technologies that are changing how we understand and deliver healthcare.

Advanced therapies, digital solutions, and biotech products are being developed at record speed, with both global leaders and startups shaping new business models and transforming the healthcare ecosystem through their innovations.

What Does Healthtech, and What Does Biotech Cover?

Healthtech encompasses a wide range of digital and technological solutions in healthcare—from tools and platforms that enable interaction with patients and improve quality of life, to technologies that help healthcare institutions optimize operations and deliver higher-quality care. Systems for collecting, processing, and exchanging medical data are particularly important, as they are becoming the backbone of the modern healthcare system.

Today, healthtech is a central pillar of modern diagnostics, treatment, and patient monitoring, and the COVID-19 pandemic further accelerated this shift, as telemedicine and digital solutions became essential to ensure access to care even under conditions of physical distancing.

Biotech, on the other hand, uses biology and living organisms to develop innovative products. Its applications include the development of medicines, gene therapies, and diagnostic solutions, as well as personalized medicine, agriculture, and sustainable development. Innovations typically originate in laboratory research and are then translated into practical products such as pharmaceuticals and genetic tests. Particularly significant avenues of development include genetic engineering and regenerative medicine, whose potential can redefine the very nature of healthcare.

These industries demand continuous investment in research and development, as well as precise coordination among scientists, regulators, healthcare institutions, and companies. The greatest challenge is balancing innovation with regulatory compliance.

The rules are strict yet evolving, and success depends on the ability to adapt in time to new standards—especially in the era of artificial intelligence. Startups face challenges in financing, intellectual property protection, and data governance, while large companies must ensure a stable and globally sustainable process for developing and distributing innovations.

Regardless of size, healthtech and biotech companies face similar questions: how to protect data, how to manage risk, how to ensure regulatory compliance, and how to continue innovating at the same time.

Why Zunic Law for Healthtech and Biotech?

The Zunic Law team understands the specifics of these industries and supports organizations in a complex business and legal environment. Our role is not only advisory but also strategic—we help clients identify opportunities, minimize risks, and maximize the value of their innovations.

Industry expertise: a combination of legal knowledge and understanding of life sciences and healthcare—from drug and gene-therapy development, through diagnostic solutions, to personalized medicine and regenerative technologies.
Regulatory compliance at all levels: the domestic framework (Law on Medicines and Medical Devices, clinical trials, data protection, IP) and European standards (EMA guidelines, GDPR, medical device regulations, biotech patents).
Support across the entire life cycle: from research and development, through protection of innovations and IP portfolios, to partnerships, financing, regulatory approval, and placing products on global markets.
Practice-oriented solutions: rapid identification of challenges and priorities—focused on what enables safe commercialization of innovations, data protection, and accelerated time-to-market.

Our Approach: Responsible Development in Healthcare

Zunic Law brings together lawyers and experts with deep understanding and experience in technology, healthcare, and life sciences.

Our mission is to help clients understand, anticipate, and successfully overcome the legal and business challenges that arise in the healthtech and biotech industries. In an environment where legal, technological, and ethical standards are continually evolving, support from a partner who can integrate all these aspects becomes crucial.

We provide support both on large, complex projects and in day-to-day operational activities.

Key Services (Overview)

Regulatory matters
Public policy and government relations
Public procurement
IT, licensing, and commercial arrangements
Data protection, cybersecurity, and privacy
Intellectual property
Corporate law, M&A, and financing
Tech startups and growth companies
Big Data, AI, and machine learning
Risk management and disputes

Below are details of our services, with an emphasis on the concrete results we deliver.

1. Regulatory Matters

Advising on approvals for clinical trials and market access for biotech and medical products, with full understanding of complex procedures required by regulators.
Compliance with health-data laws and the GDPR, especially for digital health applications and platforms that collect and process sensitive data.
Support regarding rules for advertising medicines, medical devices, and digital therapeutics, enabling transparent and safe communication with users and healthcare professionals.
Tailored solutions for companies developing telemedicine services and AI diagnostics, where the balance between innovation and legal compliance is key to market entry.

Result: safe and compliant market entry for innovative health products and services, with minimized regulatory hurdles.

2. Public Policy and Government Relations

Strategic advice on health public policies that shape the environment for developing and launching innovations in the biotech and healthtech sectors.
Assistance in communications with regulatory bodies and healthcare institutions to accelerate and facilitate approval and implementation of new technologies.
Overcoming bureaucratic obstacles in the introduction of gene therapies, personalized medicine, and disruptive technologies.
Focus on new trends such as AI diagnostic tools and digital biomarkers, which require a tailored regulatory approach.

Result: strong and predictable relationships with decision-makers that speed the path from innovation to patient.

3. Public Procurement

Support in all phases of public tenders for medical equipment, e-health systems, and biotech products—from documentation to execution.
Developing tender-participation strategies in healthcare, as well as efficient contract management after award.
Advising medical device suppliers and healthcare institutions, minimizing risk and providing legal protection during contract performance.
Accelerating projects in line with health regulations and the specifics of the public sector.

Result: successfully awarded and executed tenders that expand market presence with full legal certainty.

4. IT, Licensing, and Commercial Arrangements

IT contracts & software licensing for electronic health records and telemedicine platforms to ensure legal certainty for all parties.
Support in technology transfer, including algorithms for processing genetic data and digital health solutions.
Commercial arrangements between biotech companies and clinical centers, with clearly regulated rights and obligations.
Adapting contract models to the needs of digital health and biotechnology while protecting business interests and Intellectual property law.

Result: legally secure and flexible partnerships that enable commercialization of innovations in healthcare.

5. Data Protection, Cybersecurity, and Privacy

Implementing protection policies for health and genetic data in line with the strictest domestic and international standards.
Risk assessments and advice on cross-border transfers of medical information, minimizing regulatory obstacles.
Information security for telemedicine solutions and AI systems that process sensitive data.
Building patient trust through transparent privacy procedures and security mechanisms.

Result: protected health data and secure platforms that inspire confidence in patients and partners.

6. Intellectual Property

Support with patents for novel therapeutic molecules, diagnostic tests, and medical devices, including protection strategies.
Strategic advice on commercialization of biotech innovations and digital solutions through licensing and partnerships.
Building and managing patent portfolios for biotech and healthtech companies, with continuous monitoring for potential infringements.
Dispute resolution and protection against infringement of biomedical patents and software rights.

Result: robust protection of innovations that increases a company’s market value and competitive advantage.

7. Corporate Law, M&A, and Financing

Support for biotech and healthtech companies at all growth stages—from startup to global expansion and entry into new markets.
Due diligence relating to clinical trials, IP portfolios, and regulatory compliance to reduce investment risk.
Negotiation and structuring of M&A transactions in the healthcare and biotech sectors, accounting for regulatory specifics.
Venture capital funds and private-equity investments that enable the development of medical innovations.

Result: successfully structured investments and transactions that ensure long-term growth and business stability.

8. Startups and Growth Companies

Legal advice for digital health startups and early-stage biotech firms.
Support in protecting algorithms, patents, and other IP that underpin the business model.
Business structuring tailored to the development of new therapies, digital platforms, and innovative health solutions.
Preparation for investment and communications with funds specializing in healthtech and biotech.

Result: a solid legal foundation enabling faster growth, investor appeal, and secure market expansion.

9. Big Data, AI, and Machine Learning

Legally sound use of genetic and clinical data in AI models, with compliance with privacy regulations.
Advice on deploying machine-learning solutions for diagnostics and disease prediction while protecting patient rights.
Structuring partnerships between research institutes and biotech companies to facilitate the development of new technologies.
Developing business models based on health data analytics and its commercial application.

Result: innovative and legally secure solutions that enable the commercialization of health data and AI technologies.

10. Risk Management and Disputes

Proactive risk-management strategies in clinical trials and product distribution to protect the business.
Preventing and quickly resolving disputes over licensing of biotech solutions, focusing on preserving partnerships.
Representation in medical, arbitration, and IP disputes to minimize financial and reputational impact.
Efficient resolution of health-law challenges through a combination of preventive and reactive strategies.

Result: minimized risks and efficiently resolved disputes that protect the business and accelerate return to market.

What Does Collaboration with Us Look Like?

Rapid discovery – a quick analysis of the product or service (telemedicine, digital platforms, biotech therapies, medical devices) with the client’s key teams to identify regulatory and IP challenges.
Compliance mapping – a gap analysis against rules for medicines, medical devices, clinical trials, and health-data protection, as well as a review of contracts, IP portfolios, and business structure.
Implementation – drafting data-protection and cybersecurity policies and procedures; software and technology licensing; knowledge transfer; public procurement; R&D partnerships; and financing.
Ongoing support – continuous monitoring of regulatory developments (GDPR, EMA, MDR, AI and big-data regulation), policy updates, dispute representation, and support in communications with regulators and investors.
Commercialization and growth – legal and strategic support for entering domestic and international markets, protecting innovations, M&A transactions, partner negotiations, and structuring investments for scaling.

Examples of Completed Projects (Non-Confidential)

Provided legal support for the development and launch of digital health solutions and biotech products in domestic and international markets.
Drafted and implemented policies for protection of health and genetic data in line with the GDPR and relevant local regulations.
Successfully protected patents, trademarks, and other IP rights for startups and large companies in healthcare and biotechnology.
Prepared and negotiated agreements for clinical trials, R&D partnerships, licensing, and participation in public procurement.
Advised healthtech startups during capital-raising and investment structuring, enabling faster and safer market entry.
Provided continuous support in monitoring regulatory developments (GDPR, EMA, MDR, AI and big-data regulation) and in representation before domestic and international regulatory bodies.

Tijana Žunić Marić

Nemanja Žunić

Frequently Asked Questions (FAQ)

1. What are the biggest legal challenges for healthtech and biotech companies?

Common challenges include regulatory compliance (medicines, medical devices, clinical trials), protection of health and genetic data, intellectual property, and financing.

We help clients identify risks early and create a legal framework that enables safe development and commercialization of innovations.

2. How can we protect our innovations and technologies?

Intellectual property is crucial in this industry. We advise on patents, trademarks, copyrights, and trade secrets, and we help build IP portfolios and commercialize them through licensing, partnerships, or M&A transactions.

3. Is it possible to comply with the GDPR and local laws if we work with health and genetic data?

Yes, with careful planning and implementation. We provide solutions for collecting, processing, storing, and transferring data, including cross-border information flows.

Our team combines data-protection expertise with the specifics of the healthcare sector.

4. How can Zunic Law help startups in this field?

We work with startups from idea to global growth: we assist with business structuring, protection of innovations, capital-raising, partner agreements, and regulatory compliance.

We understand that speed and efficiency are key, so we focus on solutions that enable accelerated development.

5. Do you also support communications with regulators and government institutions?

Yes, we provide strategic advice and support in dialogue with institutions. This is especially important for disruptive technologies such as AI diagnostic tools or gene therapies, where regulation often lags behind innovation.

6. What does ongoing collaboration with your team look like?

Our approach is structured around continuous support: monitoring regulatory developments, updating policies and contracts, team training, and preparation for inspections or audits.

The goal is for the client not only to be compliant but also ready to seize market opportunities with minimal legal risk.