When do you need
a medical lawyer?

Medical law combines strict regulation with a sensitive agenda regarding patient data, and also carries potential criminal liability. Every error has a reputational, financial, and personal dimension.

Quality legal support helps healthcare providers, medical device distributors, and digital platforms establish processes that will withstand scrutiny during audits and in disputes.

When do you require a medical law attorney?

Healthcare law combines stringent regulation with a sensitive agenda regarding patient data, as well as potential criminal liability. Every error has a reputational, financial, and personal dimension. High-quality legal support helps healthcare providers, distributors of medical devices, and digital platforms establish processes that will withstand scrutiny during audits and in disputes.

English

When do you require a medical law attorney?

Healthcare law combines stringent regulation with a sensitive agenda regarding patient data, as well as potential criminal liability. Every error has a reputational, financial, and personal dimension. High-quality legal support helps healthcare providers, distributors of medical devices, and digital platforms establish processes that will withstand scrutiny during audits and in disputes.

English

When do you require a medical law attorney?

Healthcare law combines stringent regulation with a sensitive agenda regarding patient data, as well as potential criminal liability. Every error has a reputational, financial, and personal dimension. High-quality legal support helps healthcare providers, distributors of medical devices, and digital platforms establish processes that will withstand scrutiny during audits and in disputes.

Typical Scenarios We Handle

Registration and Authorization to Provide Healthcare Services

Registration and Authorization to Provide Healthcare Services

Regional Authority, non-medical services, specialization

Contracts with Health Insurance Companies

Contracts with Health Insurance Companies

System access, contract review, payment disputes

Protection of Patients' Personal Data

Protection of Patients' Personal Data

GDPR, medical records, and sharing via eHealth

Medical Devices

Medical Devices

Registration, CE marking, notified body, clinical evaluation

Complaints and Patient Disputes

Complaints and Patient Disputes

Complaint, inspection by the State Institute for Drug Control (SÚKL) or the Regional Authority, civil dispute

Digital Health and AI

Digital Health and AI

Telemedicine, mobile applications, AI in diagnostics, data and research

Who our services
are for

Hospitals and Outpatient Clinics

Operations and Compliance Agenda

Hospitals and Outpatient Clinics

Operations and Compliance Agenda

Physicians and Specialists

Executive contracts, disputes with insurance companies, personal liability

Physicians and Specialists

Executive contracts, disputes with insurance companies, personal liability

Distributors and manufacturers of medical devices

MDR/IVDR compliance, complaints, inspections

Distributors and manufacturers of medical devices

MDR/IVDR compliance, complaints, inspections

Digital health startups

Regulations on Software as a Medical Device and Telemedicine

Digital health startups

Regulations on Software as a Medical Device and Telemedicine

Pharmacies and pharmaceutical distributors

Regulatory and Contractual Support

Pharmacies and pharmaceutical distributors

Regulatory and Contractual Support

Health Insurance Companies and Care Organizers

Contracts with Providers, Reimbursement System

Health Insurance Companies and Care Organizers

Contracts with Providers, Reimbursement System

How our cooperation works

1

Initial Consultation

We will map the type of activity, the regulatory context, and the current status.

2

Legal Analysis

We identify obligations and risks.

3

Documentation and compliance

We will prepare internal processes, contracts, and informational materials

4

Implementation

Representation and assistance during inspections, registrations, and in litigation.

5

Ongoing Support

We respond to regulatory changes and new products.

What we will do for you

Licenses and Contracts with the Insurance Company

We will guide the client through the registration of health services with the regional authority, as well as the preparation and review of contracts with health insurance companies. We also provide assistance with disputed matters regarding reimbursements and audits.

Authorizations and Contracts with the Insurance Company

We will guide the client through the registration of health services with the regional authority, as well as the preparation and review of contracts with health insurance companies. We also provide assistance with disputed matters regarding reimbursements and audits.

Medical Devices Regulation

We provide counsel on medical device registration (MDR/IVDR), classification, clinical evaluation, the appointment of a person responsible for regulatory compliance, and post-market surveillance.

Patient Data Protection

We will draft data processing agreements, DPIA, information obligations, data subject rights, and security measures with specific regard to the particularities of medical records. We will represent the client in proceedings before the Office for Personal Data Protection.

Digital Health and AI

We will assess whether the software or AI falls under the Medical Device Regulation (MDR) framework and how the AI Act applies to it. We will evaluate the regulatory pathway for telemedicine, monitoring, and clinical decision support systems.

Disputes, Audits, and Liability

We represent our client in disputes with patients, insurance companies, as well as during inspections by the State Institute for Drug Control (SÚKL) or regional authorities. In the event of criminal law implications, we will align the representation with criminal defense.

How our cooperation works

1

Initial Consultation

We will map the type of activity, the regulatory context, and the current status.

3

Documentation and compliance

We will prepare internal processes, contracts, and informational materials

5

Ongoing Support

We respond to regulatory changes and new products.

2

Legal Analysis

We identify obligations and risks.

4

Implementation

Representation and assistance during inspections, registrations, and in litigation.

Examples of Our Work

Medical device registration

Our team provided the client with advisory services in the notification procedure for medical devices in the Register of Medical Devices.

Securing outward processing authorization for the client

We represented the client in a reimbursement dispute with a health insurance company following the non-recognition of a claim for reimbursement of health services.

Pavel Martinik, JD, PhD

Managing Partner

He represents clients in criminal defense matters with cross-border implications, particularly those involving economic crime. His academic background at the Faculty of Law of Charles University enables him to formulate methodical arguments supported by legal doctrine.

Pavel Martinik, JD, PhD

Managing Partner

He represents clients in criminal defense matters with cross-border implications, particularly those involving economic crime. His academic background at the Faculty of Law of Charles University enables him to formulate methodical arguments supported by legal doctrine.

Jana Rihova, LL.M.

Attorney-at-Law

She focuses on the banking sector, fintech, and corporate governance. Her practice includes licensing proceedings before the Czech National Bank and the implementation of European regulations into the structures of Czech companies. Prior to joining the firm, she served as head of the legal department at Twisto payments.

Jana Rihova, LL.M.

Attorney-at-Law

She focuses on the banking sector, fintech, and corporate governance. Her practice includes licensing proceedings before the Czech National Bank and the implementation of European regulations into the structures of Czech companies. Prior to joining the firm, she served as head of the legal department at Twisto payments.

Frequently Asked Questions

Do you have a question for which you have not found an answer?

When is software classified as a medical device?

How long does it take to register a medical practice with the regional authority?

What level of cooperation can we request from the insurance company in a dispute regarding payment?

Are we required to have a Data Protection Officer (DPO) for our medical practice?

Are we subject to NIS2?

Inquiries and Consultations

We are located in Prague, Vinohrady, just a few steps from the Náměstí Míru metro station. For routine matters, please send us an e-mail, complete our contact form, or call us to arrange an appointment. In the event of an urgent criminal matter, please contact our emergency hotline, available 24 hours a day.

Contact

+420 773 706 807
(24/7 for urgent criminal matters)

Prague Branch

Martiník law firm, s.r.o.
Uruguayská 380/17
120 00 Prague 2 - Vinohrady

Inquiry Form

Inquiries and Consultations

We are located in Prague, Vinohrady, just a few steps from the Náměstí Míru metro station. For routine matters, please send us an e-mail, complete our contact form, or call us to arrange an appointment. In the event of an urgent criminal matter, please contact our emergency hotline, available 24 hours a day.

Contact

+420 773 706 807
(24/7 for urgent criminal matters)

Prague Branch

Martiník law firm, s.r.o.
Uruguayská 380/17
120 00 Prague 2 - Vinohrady

Inquiry Form

Inquiries and Consultations

We are located in Prague, Vinohrady, just a few steps from the Náměstí Míru metro station. For routine matters, please send us an e-mail, complete our contact form, or call us to arrange an appointment. In the event of an urgent criminal matter, please contact our emergency hotline, available 24 hours a day.

Contact

+420 773 706 807
(24/7 for urgent criminal matters)

Prague Branch

Martiník law firm, s.r.o.
Uruguayská 380/17
120 00 Prague 2 - Vinohrady

Inquiry Form

Inquiries and Consultations

We are located in Prague, Vinohrady, just a few steps from the Náměstí Míru metro station. For routine matters, please send us an e-mail, complete our contact form, or call us to arrange an appointment. In the event of an urgent criminal matter, please contact our emergency hotline, available 24 hours a day.

Contact

+420 773 706 807
(24/7 for urgent criminal matters)

Prague Branch

Martiník law firm, s.r.o.
Uruguayská 380/17
120 00 Prague 2 - Vinohrady

Inquiry Form

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Prague Branch


Martiník Law Firm, LLC
Uruguayská 380/17
120 00 Prague 2 - Vinohrady

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©2026 All rights reserved.

Prague Branch


Martiník Law Firm, LLC
Uruguayská 380/17
120 00 Prague 2 - Vinohrady

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Prague Branch


Martiník Law Firm, LLC
Uruguayská 380/17
120 00 Prague 2 - Vinohrady

Manage my cookie preferences

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©2026 All rights reserved.

How our cooperation works

1

Initial Consultation

We will map the type of activity, the regulatory context, and the current status.

2

Legal Analysis

We identify obligations and risks.

3

Documentation and compliance

We will prepare internal processes, contracts, and informational materials

4

Implementation

Representation and assistance during inspections, registrations, and in litigation.

5

Ongoing Support

We respond to regulatory changes and new products.