Setting up a clinic, outpatient centre or medical practice requires more than registering a company. Healthcare activity is subject to special regulations, so already at the planning stage it is necessary to properly define the legal form, the scope of services, the structure of the facility and the way it will operate.

Our firm helps with setting up medical entities and organising healthcare activity from scratch. We support both doctors planning to start their own practice and entrepreneurs intending to open a clinic, outpatient centre or other medical facility.

We help you through the entire process – from choosing the right legal form, through preparing documents and procedures, to making the required entries and preparing the facility to start operating.

How we can help

Our support may include, among other things:

• choosing the right legal form,
• setting up companies engaged in healthcare activity,
• organising individual and group professional practices,
• registering the business in the CEIDG or KRS,
• preparing the application for entry in the RPWDL,
• preparing the organisational regulations,
• drawing up documentation for patients,
• preparing consent and authorisation forms,
• documentation on patient rights,
• preparing basic GDPR documentation,
• contracts with doctors and other staff,
• analysing the requirements for the planned scope of activity,
• help with compulsory civil liability insurance,
• support with formalities related to starting operations.

We tailor the scope of our help to what kind of facility is to be created, what services will be provided there and how it is to be organised.

Choosing the legal form for a medical business

One of the first decisions is choosing the form in which the facility will operate.

The situation of a doctor who wants to run their own practice is different from that of several partners planning to create a larger clinic employing many specialists.

Depending on the assumptions, the business may be run, among other things, by a sole trader or a company. People practising certain medical professions may also operate in the form of a professional practice, under the rules provided for that profession.

When choosing a solution, we analyse, among other things:

• the number of people involved in the venture,
• the planned scope of services,
• how the business will be financed,
• the liability of individual people,
• the rules for managing the facility,
• the possibility of further development,
• planned staff recruitment,
• the future entry of a partner or investor.

The legal form should reflect how the facility is to operate in practice, rather than merely allowing it to be registered quickly.

Setting up a clinic or outpatient centre

When creating a larger medical facility, business issues must be properly combined with the requirements of medical law.

We help plan the structure of the entity, define the scope of activity and prepare the documents needed to start operating.

If the clinic is to operate as a company, we can also prepare its articles of association and carry out the registration process.

At this stage, it is worth establishing, among other things, who will manage the facility, how the staff will be organised, what services will be provided and what cooperation with specialists will look like.

Preparing these issues well at the outset makes it easier to run the facility later and reduces the need for further changes after it starts operating.

Registration in the RPWDL

An entity intending to conduct healthcare activity must obtain the appropriate entry in the Register of Entities Performing Healthcare Activity (RPWDL).

As part of the registration, it is necessary to correctly specify, among other things:

• the entity’s details,
• the place where services are provided,
• the organisational and legal form,
• the type of healthcare activity,
• the scope of services provided,
• the organisational structure of the facility.

We help prepare the data and documentation needed for the entry and guide the client through the registration procedure.

Healthcare activity may begin once the required entry in the relevant register has been obtained.

Organisational regulations of the facility

One of the basic documents of a healthcare provider is its organisational regulations.

They should reflect how the facility actually operates, rather than being merely a document prepared for registration.

We prepare regulations that take into account, among other things:

• the organisational structure of the facility,
• the type and scope of services provided,
• the places where they are provided,
• the process of providing services,
• the organisation of individual units and departments,
• the rules of cooperation between staff,
• issues related to fees for certain services.

We tailor the content of the document to the specific clinic and how it is actually to operate.

Documentation for patients

The facility should be prepared not only organisationally, but also in terms of the documents used from the first day of contact with patients.

We help prepare, among other things:

• consent forms for the provision of services,
• information provided to patients,
• authorisations to provide information about health,
• authorisations concerning medical records,
• forms related to specific procedures,
• procedures for making records available,
• other documents required for a specific type of activity.

We do not recommend using random templates available on the internet. The documentation should reflect the services actually provided by the facility and the way treatment is organised.

Patient rights from the start of operations

When creating a new facility, it is worth ensuring from the outset that its solutions comply with patient rights.

This concerns, among other things, the right to information, informed consent, medical records, confidentiality and respect for privacy and dignity.

We help prepare documents and procedures so that staff know how to act in typical situations arising in daily work.

This helps avoid a situation in which rules of conduct are created only after the first complaint or conflict with a patient.

GDPR and medical data

From the moment patient registration begins, the facility starts processing personal data, including specially protected health information.

That is why data protection issues are worth putting in order before the first patient is admitted.

We help prepare documentation and solutions concerning, among other things:

• information obligations,
• authorisations for staff,
• rules of access to data,
• cooperation with external entities,
• the use of IT systems,
• online registration,
• storing and securing records.

The solutions should reflect the actual flow of information in the facility.

Contracts with doctors and staff

A new clinic also requires proper regulation of cooperation with the people who will work there.

We draft and review contracts with doctors, medical staff, administrative employees and other associates.

Depending on the nature of the cooperation, we regulate, among other things:

• the scope of duties,
• the rules of remuneration,
• the liability of the parties,
• keeping medical records,
• the duty of confidentiality,
• use of equipment and infrastructure,
• the organisation of work,
• the rules for ending cooperation.

Contracts should be tailored to the actual model of cooperation, especially when the clinic uses both employees and people providing services under contracts.

Civil liability insurance

An entity conducting healthcare activity should also hold the required civil liability insurance.

Already at the stage of creating the facility, it is worth establishing what insurance cover is required and whether, apart from compulsory cover, additional insurance for the business is advisable.

If necessary, we help analyse issues related to the liability of the facility and the specialists working with it.

Premises, equipment and organisation of services

Opening a medical facility also involves requirements concerning the place where services are provided and the equipment used.

The scope of obligations depends on the type of activity and the services to be provided.

That is why, before launching the facility, it is worth checking whether its organisation meets the requirements applicable to the planned type of activity.

Not all requirements will be the same for a consultation practice, a procedural clinic, an outpatient centre or a facility performing specialist procedures.

If necessary, we help establish which additional regulations apply in the specific case.

Cooperation with the NFZ and other institutions

If the facility is to provide publicly funded services, starting operations may also involve additional formalities related to cooperation with the National Health Fund (NFZ).

We agree the scope of such support individually, depending on the business model and the planned way services will be financed.

We also help in dealing with other authorities and institutions if their involvement is required when launching a specific type of medical activity.

A facility ready for its first day of operation

Obtaining an entry in the register alone does not mean that all legal issues have been settled.

Before admitting the first patients, it is worth checking whether the facility has:

• proper documentation for patients,
• organisational regulations,
• procedures for medical records,
• data protection documentation,
• appropriate contracts with staff,
• the required insurance,
• rules for responding to complaints and unusual situations.

As a result, the business starts on an orderly basis, and procedures do not have to be created only when the first problem arises.

Setting up medical entities – support from idea to opening

Every medical facility is different, so the process of creating it should take into account the type of services, the structure of the team, the method of financing and plans for further development.

At the outset, we learn about the client’s business assumptions and establish which business model best meets their needs. We then help prepare the legal structure, documentation and required filings.

Once operations have begun, we can also provide the facility with ongoing legal services, update its documentation, train staff and support it in dealing with patients and institutions.

Our aim is to create a secure legal foundation for the facility so that its owners can focus on organising the business and caring for patients.