Setting up in private practice: medico-legal considerations

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One of the attractions of setting up as an independent practitioner may be greater freedom to make decisions about the number of patients you see and the treatments you offer. 

With this comes responsibility for areas which may have previously been undertaken by other healthcare professionals. Here we examine some of the medico-legal challenges facing consultants who are about to begin independent practice.

Regulation

GMC

In common with other doctors independent practitioners must be registered with the GMC and hold a licence to practise. They also retain all professional obligations regarding ethical standards, revalidation and fitness to practise. 

Care Quality Commission (CQC)

All independent health and social care services in England are required to register with the CQC for: 

  • the type of work they do, and 
  • at each location in which they carry out that work.

Doctors consulting in a private hospital may not need to register separately if the hospital is appropriately registered, but this exemption will only apply where consultations are carried out under the organisation's management and policies, including those relating to clinical governance, audit and complaints handling. 

Doctors who are employed by the NHS alongside their independent practice may also be exempt from registration. However, this exemption will not apply where doctors work in a group if even one member is not employed by the NHS. This exemption will also not apply where certain procedures, such as treatment under sedation or anaesthesia, are carried out. This is a complex area and failure to register with the CQC when this is a requirement can amount to a criminal offence. Members can seek our advice if they have any questions about whether they need to register. 

More information can also be found at cqc.org.uk


Indemnity

As NHS indemnity only applies to clinical negligence claims against NHS bodies, it is important to make sure you have appropriate indemnity for your independent practice, including medico-legal work. 

The GMC's guidance Good medical practice (2013) states 'You must make sure you have adequate insurance or indemnity cover so that your patients will not be disadvantaged if they make a claim about the clinical care you have provided in the UK.' 

Contact our membership team on freephone 0800 716 376 to discuss your indemnity requirements before doing any independent work. 

It is advisable to ensure that the healthcare professionals you employ, such as nurses, are suitably indemnified in their own right where appropriate and that you confirm their registration status.


Marketing your services

It is important to be careful when promoting your services as an independent practitioner. Good medical practice (2013), paragraph 69, states 'When advertising your services, you must make sure the information you publish is factual and can be checked, and does not exploit patients' vulnerability or lack of medical knowledge.'

Any advertisement you make will need to comply with the Advertising Codes enforced by the Advertising Standards Authority. You may also need to consider the Medicines and Healthcare products Regulatory Agency's guidance on the advertising of medicines (The Blue Guide) which can be found online at gov.uk 

It is essential to ensure you have written consent from the patients concerned if you intend to use testimonials or patient photographs. 

If a third party (such as a clinic) is publishing material on your behalf, it is important you make sure it meets the required standards. As other people's perceptions are important, it may be helpful to consider seeking the views of an impartial colleague or your medical defence organisation beforehand.

Independent practitioners who are registered with the CQC need to apply for permission to use its logo on advertising materials and must abide by its terms and conditions. All these considerations are also relevant if you promote your services via a website.

There is a statutory requirement to take reasonable steps to make it accessible to people with disabilities. The RNIB and the Disability Rights Commission offer advice on this.

If you offer general medical information on your website you should include a statement that it is general advice only and should not be used as a substitute for face-to-face consultations. If you link your website to another, you should inform patients you cannot guarantee that another website is secure and you do not necessarily endorse the contents of the site. 

The GMC expects doctors to protect patient information. No electronic system is 100% secure but if you communicate with patients by the internet or email you must warn them that it may not be secure and they need to be told how their data will be used. 

Independent practitioners considering providing remote consultations should follow the GMC's specific guidance


Medical records

If you hold medical records about your patients, you have an obligation to keep them safe and confidential. You need to consider how long to retain records and who will handle them if you are no longer able to do so. Although there are no guidelines for retention of clinical records in private practice, paragraph 119 of the GMC's guidance on Confidentiality (2017) states 'You must make sure that any personal information about patients that you hold or control is effectively protected at all times against improper disclosure or loss. The UK health departments publish guidance on how long health records should be kept and how they should be disposed of. You should follow the guidance whether or not you work in the NHS'. 

If you intend to process electronic data relating to private treatment, you are likely to have to register as a data controller under The Data Protection (Charges and Information) Regulations 2018. You can find out how to register from the Information Commissioner's Office (ICO) website ico.org.uk 

Whether you need to register with the ICO or not, you will still be obliged to comply with the GDPR and DPA 2018, which includes informing patients about what data you are collecting, the reasons for doing so, their rights and the legal basis for processing their data. The ICO has produced guidance regarding privacy notices.


Fees

The most obvious point of difference with your previous experience is that independent practice is a business operation. It is your responsibility to be honest and open in any financial dealings with patients. Paragraph 4 and 5 of GMC guidance Financial and commercial arrangements and conflicts of interest (2013) says: 

'4 If you charge fees you must:
  1. tell patients about your fees, if possible before seeking their consent to treatment
  2. tell patients if any part of the fee goes to another healthcare professional.

5 You must not exploit patients' vulnerability or lack of medical knowledge when charging fees for treatments and services.' 

You should also take care when offering or providing private treatment to patients you have already seen on the NHS, so that others do not misinterpret your actions. You will need to declare any potential conflicts of interest that may arise. HMRC inspectors may ask to see invoices for your private patients. Tax inspectors have legal powers to obtain documents under Schedule 36, Part 1 of the Finance Act 2008. They can request, in writing, any information or document it is reasonable for them to have to assist in checking a taxpayer's position. You should satisfy yourself it is reasonable to provide that information. 

It may be possible to give the necessary information in an anonymised form.

The GMC says, 'if you are asked to disclose information about patients for financial or administrative purposes, you should give it in anonymised form, if that is practicable and will serve the purpose. If identifiable information is needed, you must be satisfied that there is a legal basis for breaching confidentiality. You must also be satisfied that the other relevant requirements for disclosing information are met'. 

If seeking patients' consent or anonymising/coding the information requires unreasonable effort, it may be justifiable to provide relevant information.


Protection of vulnerable groups

A Disclosure and Barring Service (DBS) check may be required at each hospital at which you have practising privileges. Different rules apply in Scotland (Disclosure Scotland) and Northern Ireland (Access Northern Ireland).

If you employ other staff, you are obliged to obtain DBS checks depending on the work they do. The type of check that is done will depend on the work they do. Further advice can be accessed online from the Disclosure and Barring Service section of gov.uk

You should also be aware of employer responsibilities under the Safeguarding Vulnerable Groups Act 2006, which include a duty to refer to the Independent Safeguarding Authority information about employees you consider may pose a risk, or have harmed children or vulnerable adults.


Complaints procedures

If something has gone wrong during the care of a patient, the MDU advises you to provide an explanation of what has happened, an apology where appropriate, and assurance that steps will be taken to prevent a recurrence. The GMC's guidance in Good medical practice (2013), paragraph 55, states 'You must be open and honest with patients if things go wrong. If a patient under your care has suffered harm or distress, you should: 

  1. put matters right (if that is possible) 
  2. offer an apology
  3. explain fully and promptly what has happened and the likely short-term and long-term effects'.

All complaints, even verbal ones that might have been resolved at the time, should be logged and dated. If you see patients in an independent hospital or clinic, the hospital or clinic is required to have a complaints procedure. If you see patients in other settings, it is important to develop your own in-house complaints procedure that is clearly set out and communicated, and easy for patients and staff to use.

Unlike complaints related to patients receiving NHS funded care, there is no statutory framework for independent review of complaints from the independent sector.

Responding to a complaint in a timely and sympathetic way, including an apology where appropriate, e.g. for any distress caused, may well help to resolve the complaint at an early stage. An apology is not the same as admitting liability and is expected by the GMC where appropriate as part of a 'prompt, open, honest and constructive response'.

It can also be useful to offer the complainant the opportunity to meet to discuss their concerns, perhaps in the presence of a conciliator. On some occasions, a goodwill payment or a refund without any admission of liability may be successful in resolving dissatisfaction but there is no guarantee that this will be effective. This would be a matter for the individual clinician to decide, but the MDU would be happy to discuss this with members and assist in wording any letters. It may be helpful to model your procedure on the current NHS and social care complaints procedure, addressing complaints using a local resolution procedure. 

Unlike complaints related to patients receiving NHS funded care, there is no statutory framework for independent review of complaints from the independent sector. Some independent healthcare organisations are members of the Independent Sector Complaints Adjudication Service, which publishes a Complaints Code of Practice for its members and offers an independent review service for cases where local resolution and complaints review within the organisation fails to resolve the complaint. 

The CQC has a remit to monitor private complaints in England, and independent practitioners are required by law to provide an annual summary of complaints to the CQC. 

The MDU has published a guide to the NHS complaints procedure.


Business laws

As a potential employer, it is also important to be aware of any relevant legislation or regulations which may affect your business, for example, the need for employers’ liability insurance, the Control of Substances Hazardous to Health (2002) regulations, and various other employment, health and safety, and equality legislation. You may wish to take advice from an appropriately skilled and experienced expert in these fields. 


Corporate indemnity for your business

Traditionally, claims for clinical negligence have been made against individual healthcare professionals. Where doctors own, or are employed by a limited company, it is increasingly likely that a claim may be made against the company itself. We offer a comprehensive solution for your business, including indemnity and expert risk management support. For more information, please visit themdu.com/corporate


We run courses for consultants who are considering setting up in private practice. Visit themdu.com/learn for more information and to book.

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This page was correct at publication on . Any guidance is intended as general guidance for members only. If you are a member and need specific advice relating to your own circumstances, please contact one of our advisers.

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