Health start-ups: Look to the future – a round-up
“Look to the future now: it’s only just begun”
So sang Wolverhampton glam-rockers Slade in their well-known Christmas hit. Whilst I accept that it is still probably a little early to be getting ready for Christmas, these particular words nevertheless seem an apt way of bringing to a close our series of articles on healthcare start-ups and the increasing use of apps and technology for delivering health services. Even in the few months since our first article things have not stood still, and nor would we expect them to. The CQC in particular has started publishing its first reports into such healthcare providers and so in this piece, we look at some of the learning points and warning signs already laid out, as well as offering a reminder of some of the key points of learning from previous articles in the series.
In March this year, the CQC published advice for people considering using an online doctor, published information on how digital primary care providers are regulated and inspected by the CQC, and issued a joint statement with GMC (amongst others) reminding clinicians and service providers that they still need to follow their usual professional guidelines. The CQC’s Chief Inspector of General Practice, Professor Steve Field, was quoted as saying: “This might be a new way of working, but the risks and responsibilities need to be understood and action taken in response. As the regulator of health and social care, we will continue to play our part in guaranteeing this.”
Looking first at the guidance for those thinking of using an online doctor, the CQC sets out some information designed to reassure patients – so it makes sense if you have these issues in mind when both promoting and running your services. CQC registration, where it is required, is of course a must, but it’s also important to clearly flag your address and contact details, as well as how you will safeguard patients’ confidential information. This links up with our previous articles in the series on data protection and the legal requirements for ‘distance selling’. Beyond this, there are the parameters for an online consultation – the importance of the doctor verifying the patient is who they say they are, taking a medical history, and asking permission to share the consultation with the patient’s GP. It also touches on online prescribing (see also our earlier article in the series, as well as some further points below) and having medical tests done online.
The regulation document is, as you might expect, a more detailed paper and so you should certainly familiarise yourself with it if you have not already done so. Its full name is “Clarification of regulatory methodology: PMS digital healthcare providers” and the section at the end on ‘Additional Prompts for Digital Healthcare Providers in PMS’ is a helpful checklist of key questions and prompts. In turn, this should help you shape your policies and procedures to help minimise the risk of problems arising. For example:
- What protocols are there to identify and verify the patient at the start of the first and subsequent consultations?
- How does the provider ensure compliance with appropriate guidance on remote prescribing?
- How does the provider obtain/assess informed consent?
The last of these is a case in point, as a recent inspection report specifically highlighted that the CQC had seen no evidence of formal training about the Mental Capacity Act 2005 and noted that the provider’s consent policy did not meet the requirements of that Act. This links to other warning signs in the inspection reports that have been published. Certainly prescribing is a thorny area (see also our previous article on this) and care must be taken in this area. For instance, one service was suspended after prescribing drugs following only a 17 second assessment; another had conditions placed on it for prescribing opioid-based medicine without proper patient identification systems, and the CQC in a different matter was concerned about someone being prescribed the narcolepsy-drug Modafinil to keep them awake to complete an assignment at work.
These kinds of examples highlight both the importance of having suitable policies and procedures in place and also having a suitable mechanism for checking compliance with them. Again, quoting Professor Steve Field: “As with conventional GP surgeries, online companies and pharmacies are required to provide safe, high-quality and compassionate care and must adhere to exactly the same standards. They must not cut corners.”
In terms of our top 10 tips for people in the process of (or who are considering) setting up an online and / or app-based healthcare business, we would say:
- Build in a suitable planning phase: a year or so is not unrealistic – there’s a lot to consider and plenty of potential pitfalls, but good planning at the outset will pay dividends later.
- Take care when discussing your ideas with possible partners and investors: a confidentiality agreement (sometimes called a ‘non-disclosure agreement’) provides vital protection against others ‘borrowing’ your plans – and think too about properly protecting your intellectual property.
- Map out the personal data you will be collecting or passing on to others and ensure that privacy policies and consent forms tie in to this.
- Don’t forget that some (but not all) smartphone apps can count as medical devices and, if they do, you’ll need to be aware of the relevant regulations.
- Online prescribing is a complex area so take particular care here.
- Any contract formed with a person who isn’t physically with you in the room (including clicking on a website or on an app) is likely to be ‘distance selling’ so you’ll need to ensure that your terms and conditions take account of this.
- Patients will almost always count as ‘consumers’ for the purposes of the law so make sure your patient-facing documents are clear and accessible.
- Don’t assume that you will automatically own the content of your own website – make sure that this is expressly agreed with whoever designs your site for you.
- A person you work with being ultimately considered an employee, worker, or as self-employed can depend on a range of factors which can certainly go beyond whatever label is attached to the documents.
- Keep up to date with the CQC’s inspection reports and guidance, since as more reports come out, it will be easier to establish what is good practice and help you minimise the risk of repeating the mistakes of others.
Whilst there’s certainly plenty to be wary of with this kind of business, there are also lots of potential opportunities and so plenty to be positive about too.
After all, it is Christmas…well, nearly.