Medical Practice Management: Legal and Administrative Compliance

A medical practice is subject to three separate regulatory frameworks, each with its own supervisory authority, timetable and penalties: ethical and professional body obligations, employer obligations, and those relating to health data. The difficulty lies not in the complexity of each individual framework, but in the fact that they operate in parallel — and that a breach in one is often uncovered during an audit relating to another.

Establishment and regulatory framework

Practising the profession requires registration with the relevant professional body and the registration of one’s qualification. The contract governing the practice — whether an association, independent collaboration or locum work — must be submitted to the professional body, which verifies its compliance with ethical standards.

Three points are frequently overlooked at this stage:

• The non-competition or non-relocation clause Any clause appearing in a collaboration agreement must be limited in time and scope, and proportionate. An excessive clause will be set aside, but it is better to negotiate it than to litigate it.
• The replacement contract must be drawn up in writing and submitted to the order, including in the case of a short-term replacement.
• Theprofessional indemnity insurance must be taken out prior to the first transaction, with particular attention paid to covering the past if a previous financial year has taken place — a topic covered in our article on the professional indemnity.

The firm as an employer

From the moment it takes on its first employee — whether a secretary, assistant or nurse — the practice becomes an employer subject to employment law and the applicable collective agreement.

The most fundamental obligations are those whose absence is immediately apparent during an inspection: pre-employment declaration, a written contract where required, mandatory notices, the single staff register, health and safety induction, and Single document for the assessment of occupational risks.

The latter is most often missing in small organisations, even though it is mandatory from the moment a business takes on its first employee. In a medical practice, it must cover specific risks: biological exposure, manual handling, psychosocial risks, and work involving the use of display screen equipment.

Added to this is the recording of working hours where working hours are not collectively agreed, the evidential implications of which are discussed in our article on overtime.

Health data in everyday life

This is the regulatory framework where non-compliance is most costly, and it hinges on everyday actions.

The firm is data controller of its patients’ data. It must maintain a record of processing activities, inform patients, define retention periods, and enter into contracts with its data processors — software providers, hosting providers and virtual secretarial service providers.

This gives rise to three practical requirements:

• Thehosting Data must be secured by a body certified for this purpose, including when the business software is used online.
• The authorisations must be individual and distinct: an account shared between several people makes traceability impossible and constitutes a breach in itself.
• The discussions The exchange of health data between professionals requires a secure healthcare messaging system, not a general-purpose messaging service.

Access logging and retention periods specific to medical records are detailed in our article on the electronic health record, and the sharing rules in the one dedicated to medical confidentiality.

Reception of the public and premises

The firm is a business open to the public, which entails obligations toaccessibility and fire safety proportionate to its category. A public accessibility register must be made available.

In addition, the site displays fees and terms of service, as well as information on dispute resolution procedures.

The management of waste from healthcare activities posing an infection risk This falls under a dedicated process, involving an agreement with an approved service provider and the retention of tracking slips. It is a simple and frequent checkpoint.

Invoicing and dealings with the health insurance scheme

Invoicing complies with the applicable fee scales and regulations on fee surcharges, which must be displayed.

Two record-keeping obligations need to be organised in advance: the retention of treatment forms and supporting documents in accordance with the applicable retention periods, and the traceability of requirements, the framework for which is set out in our article on digital regulations.

A health insurance audit focuses primarily on the consistency between the procedures billed and the patient records. This is where the quality of record-keeping has a direct impact, extending far beyond its medical function.

Use cases

First recruitment. Deal with the following in order: prior declaration, written contract, registration with the occupational health service, single document. The latter is most often overlooked and most routinely requested.

Change of business software. Check the hosting certification, data reversibility and export format before signing. Migrating without a recovery plan exposes you to the risk of losing records for which retention periods are still in force.

Association of several practitioners. Distinguishing between access authorisations to patient records for healthcare professionals and for patients. Belonging to the same organisation does not imply involvement in the care of every patient.

Frequently Asked Questions

Is the single document mandatory in a small practice? Yes, from the very first employee, with no minimum headcount requirement. It must cover the risks specific to the business, including biological and psychosocial risks.

Is a certified hosting provider required for online software? Yes, provided that health data is hosted on behalf of the practice. The practice, as the data controller, is responsible for verifying this.

Is a shared IT account acceptable? No. Authorisations must be individual; otherwise, it is not possible to trace access – which constitutes a separate breach.

Can patient data be exchanged via ordinary email? No. The exchange of health data between professionals requires a dedicated secure messaging system.

What are the obligations regarding healthcare waste? A dedicated process, an agreement with an accredited service provider, and the retention of tracking slips, which are regularly requested during audits.

Is a non-reinstallation clause valid? Only if it is limited in time and scope and proportionate to the protection of legitimate interests. An excessive clause will be set aside by the court.

Key points

Three regulatory frameworks operate in parallel, each with its own supervisory authority. The easiest to comply with is the employer framework, where breaches are visible and the corrective measures are well-known — the ‘single document’ being the prime example. The most costly is the healthcare data regime, where routine practices lead to non-compliance: shared accounts, consumer-grade email services, unverified hosting.

One system serves all three purposes at once, and this is the one to start with: individual and differentiated access rights, combined with access logging. They demonstrate that the ‘necessary for the task’ principle has been respected; they protect the practitioner when accused of unauthorised access; and they provide the required audit trail during an invoicing audit or in the event of a liability claim.