The rise of functional medicine and longevity
Wellness meets regulation
In recent years, the wellness and functional medicine industry has seen rapid growth, driven by an increased demand for personalised, preventative, and holistic approaches to health. More individuals are turning away from conventional medicine in favour of alternatives that emphasise longevity, healing, and overall well-being. From biohacking and vitamin drips to stress management and preventative health programmes, fertility and other femtech products , the wellness industry is booming.
As interest in wellness surges, organisations are stepping up with innovative solutions designed to enhance individual health. These include:
- Mobile applications
- Wearable technologies
- Nutritional supplements
- Holistic therapies
- At-home diagnostic and testing kits
These can all be considered as both medical treatments and wellness treatments depending on their purpose and function, and they often operate in a regulatory grey area. It is crucial for organisations in this space to understand that their products and services may still be subject to healthcare regulations. Key regulatory considerations that organisations must consider are:
- Care Quality Commission (CQC) Registration – Determine whether your services require registration with the CQC.
- Medical Device Classification – Evaluate whether your product qualifies as a medical device, which would subject it to the UK Medical Device Regulations.
- Clinical Claims and Advertising – Determine whether you are complying with advertising requirements in your marketing of the product or service.
- Data Protection Compliance – Ensure you are complying with privacy rules when developing your services.
Do your services need to be registered with the Care Quality Commission?
If you are an organisation or individual planning to deliver health-related service, it is essential to understand whether your activities fall under the scope of the Care Quality Commission (CQC)’s regulated activities. If they do, registration with the CQC is a legal requirement under the Health and Social Care Act 2008.
When determining whether the services fall within the regulated activities of the CQC, the focus is on
- the overall purpose and nature of the activity,
- who is delivering the service (including under specific types of supervision).
If you are unsure whether your services fall within the list of CQC regulated activities our Commercial Healthcare team will be able to advise on this.
Does your product qualify as a medical device?
All medical devices must be registered with the Medicines and Healthcare products Regulatory Agency (MHRA) and must comply with applicable legal and regulatory standards, including having UKCA or CE marking.
Under the Medical Devices Regulations 2002 (as amended), a medical device is broadly defined. It includes instruments, apparatus, appliances, software, and other articles intended by the manufacturer for use in human beings for purposes such as:
- Diagnosis
- Prevention
- Monitoring
- Treatment
- Alleviation of disease
Importantly, this definition also extends to software that performs these functions, referred to in the regulations as Software as a Medical Device (SaMD).
If your product is classified as a medical device, you must ensure it meets all relevant MHRA requirements, including registration, conformity assessment, and post-market surveillance obligations.
Are you making clinical claims and complying with advertising requirements in your marketing communications?
When promoting health-related products, organisations must take care not to make clinical claims that could breach UK advertising regulations.
Regulatory Oversight by the MHRA
The MHRA is responsible for regulating medicines and medicinal devices. Organisation should be aware of the MHRA’s regulatory requirements, including for advertisement, if the products could be classed as a medicine or medicinal device.
Importantly, companies should note that the way a product is advertised can affect whether it is deemed to be a medical device.
Advertising Medical Devices
Currently, medical devices are not specifically regulated under UK advertising legislation. However, the UK government has indicated plans to introduce dedicated regulations in the future.
As such, general advertising law should be considered in lieu of any specific legislation for the advertisement of medical devices. In addition, the Advertising Standards Authority has published guidance on advertising medicines, medical devices, health-related products and beauty products (as set out further down in this article), and this should be complied with.
Digital Markets, Competition and Consumers Act 2024 (‘DMCC Act’)
When advertising medical devices to the general public, organisations must comply with the new DMCC Act. This legislation is designed to protect consumers and builds on the previous Consumer Protection from Unfair Trading Regulations 2008.
Specifically, the DMCC Act prohibits unfair commercial practices, for example if an advertisement:
- Contains misleading actions or omissions;
- Is aggressive; or
- Materially distorts or is likely to materially distort the economic behaviour of the average consumer with regard to the product.
The DMCC Act has introduced new unfair commercial practices, including a prohibition on fake reviews in order to protect consumers. Please see here for further information on the DMCC Act.
Role of the Advertising Standards Authority (ASA)
The ASA is the UK’s independent regulator of advertising across all media. It enforces the CAP Code (the non-broadcast code) and the BCAP Code (the broadcast code) which applies to consumer advertising.
There are general rules in both Codes which apply to all advertisements, and then additional rules for advertisements in a particular industry. As general principles, all claims must be evidence based and substantiated. There is a chapter in both the CAP Code and BCAP Code for advertising medicines, medical devices, health-related products and beauty products. The ASA also regularly publishes guidance on popular services or products, such as permitted claims for weight loss drugs and nutritional supplements.
Additionally, the ASA’s website hosts a database of past rulings, which can be a valuable resource for understanding what types of claims have previously been found non-compliant. The ASA’s approach is to typically seek to work alongside companies who have breached rules, by first inviting companies to remove the offending material. However, the reputational risk to companies remains as the rulings are available on the ASA website.
Are you complying with data protection requirements?
Organisations operating in the wellness and health sectors must take care to design and operate their apps and services with data protection requirements in mind. Keeping data safe is a given, but data protection law imposes much wider range of governance obligations and accountability for data.
There are big risks in using ‘off-the-shelf’ privacy notices and policies for apps and websites, due to the specific requirements that arise in this wellness and health sector. These include:
- What is the lawful basis for processing sensitive information about users? The law allows health data and other sensitive information to be processed by health and care professionals, under a duty of confidence, for the purposes of providing and managing health and care services. However, many wellness services and app functions do not amount to the provision of health and care. In these circumstances explicit consent of users is likely to be required. This cannot be inferred from use of the app – it must be a specific, informed, unambiguous statement of consent, collected separately to any terms and conditions. Reliance on consent also means that functionality for consent to be withdraw, and the data to be deleted, must be designed into the app. What purposes will the data be used for? While user’s data is primarily to deliver services to them, the data can often serve wider purposes including monitoring and improving services, developing new services, and research. This is all possible but only if providers put in place the proper safeguards and information for users to enable this to happen in a legally compliant and ethically acceptable manner. It is best to get this right from the outset rather than seeking to introduce to new uses of data for existing users.
- Is there any automated decision-making which as a legal or similarly significant effect on users? This is unlikely to be the case for unregulated wellness apps but apps involving provision of regulated healthcare services could be engaged, given the significance of decisions about diagnosis or treatment. Data protection law prohibits automated decision-making without meaningful human involvement in decision-making or explicit consent of the user.
- Who has control of and access to the data? Access to wellness apps and services is often not solely directly to consumers. They can be commissioned by NHS and private health and care providers, insurers, and employers. In these circumstances real thought needs to be given as to the overall control and accountability for security and use of the data.
link