Category Archives: Medicolegal

For the Record: Can Patients Record Clinical Consultations?

RECORD

Somewhere in the ITV archives is television footage of me, on my first day in the PED as an ST3 doctor, assessing a child with a scald in resus.

I knew before I started my six month PEM rotation that the crew weren’t quite finished their filming commitments but at no point had I considered that, as the 8am starting doctor, I would find myself with a camera in my face explaining the importance of first aid for burns before I’d even acquired a set of scrubs. The stress of the situation was matched when the episode aired on national television some months later. The narrator was good enough to point out that although it was my first day, I had a lot of experience dealing with children and burns.

I remember my non-medical family being very excited about my upcoming television appearance. I also remember being terrified. Why? Because no-one needs to know that they look like a total idiot doing the thing that they do all day, every day.

Later the same month I was captured by the same crew trying to put small-sized gloves (my hands are medium-sized but for practical reasons at the time – boom mic, small cubicle, distance to hand towels, proximity of box of small gloves) over my wet hands. Thankfully this incident was edited out.

 

There is a phenomenon whereby people do strange and unexpected things under scrutiny; I’m sure those of you who examine in OSCEs at all levels of training have many wonderful and entertaining stories. There are things we do under the pressure of being watched which we ourselves struggle to understand. I hope that regular OSCEs and increasing comfort with the practice of high-fidelity simulation will go some way towards reducing the associated anxieties and normalise our behaviour in these circumstances.

But what about when the recording is being done by a patient?

Let’s imagine a scenario. You call the next patient from the waiting room into the cubicle, introduce yourself and ask how you can help. The patient whips out an iPad and sets it up on the desk.

“You don’t mind if I record this, do you?”

 

[DDET What is your immediate reaction?]

Like me, you may feel the immediate OSCE gut-squeeze: IT’S A TRAP!

The patient is trying to catch me out! And besides, they can’t record the consultation, because of patient confidentiality… or something… Or can they? [/DDET]

[DDET Can patients record the consultation?]

This is a relatively new problem but one which we may start to see occurring more regularly in clinical practice as smart phones and portable devices are ever more commonplace.

The short answer is yes: the patient can record the consultation and it is certainly not unlawful (in the UK) for the patient to do so. In recognition of the fact that this issue may arise in practice the Medical Protection Society produced some great advice in 2012 which you can read here. In summary:

It is polite to ask permission before recording someone; if the patient asks and you feel uncomfortable, you can request that the patient does not record the consultation.

If you ask the patient not to record and they do not comply, you have a duty of care and you should be wary of refusing to see/treat the patient on the basis of their recording.

Ultimately if you are behaving professionally there is nothing to fear: recordings help patients to recall complex information (we know that we are useless at remembering most of what we are told) and provide a more accurate log of events than our often scanty medical records. It is advisable to request a copy of the recording to supplement the patient’s notes. [/DDET]

[DDET What if the patient is recording covertly?]

When the recording takes place covertly – that is, without your knowledge – the biggest risk is harm to the trust between you as the clinician and your patient. Otherwise all of the principles above apply; the data being recorded is the patient’s own (although the recording may include your face and voice you will usually not be sharing any data about yourself) and so it is exempt from data protection principles as long as it is for their personal use as this guide from the Medical Defence Union explains.

The data belongs to the patient and they are entitled to do what they want with it – include posting it on the internet. [/DDET]

[DDET Can relatives record the consultation?]

This is more complicated and relies on the patient’s consent. If the patient is unable to consent (for example, unconscious) then the answer is no. The patient should be aware that the data being recorded is theirs and as such they may wish to ensure that the device being used is also theirs.

When the patient is legally a child, guidance is greyer. Parents are routinely copied into correspondence about their children and there is some common ground here. If it is the young person who wishes to make the recording it is a good idea to recognise that as an excellent opportunity to involve them in their care. In any circumstances where the recording is not being undertaken by the patient themselves, a quick chat about stewardship of digital recordings might be pertinent. [/DDET]

[DDET Is the recording something to be worried about?]

No. Behave professionally and be polite and courteous towards your patients and there is nothing to fear from being recorded. However uncomfortable we might feel there is no legal basis for the trust in a doctor-patient relationship but there is legal basis for the handling of patient data.

It may be worth exploring why the patient wants to record the consultation as this may expose particular concerns you can then address.

In some circumstances, recordings made without your consent may be admissable as evidence in court but if this occurs then the defence will be entitled to both a copy of the recording and a transcript prior to the court date so that both parties can confirm that the interaction constitutes an accurate (and unedited) record.

In this recent ADC editorial (not FOAM), Ian Wacogne explores the relationship between patient consultations and the digital age. He quite rightly advises that we should not ignore the issues that the availability of technology – and of medical opinions – bring to us:

We cannot put our fingers in our ears and chant ‘la la la la’, hoping that this will go away.

[/DDET]

And of course, this is very different from the circumstances in which doctors record consultations with patients – there is GMC advice on that here. This post is based on UK law and may be different in other parts of the world.

GMC Guidance on social media use by doctors. St.Emlyn’s

Firstly apologies for the slow updates of late. I am ‘away from the desk’ so to speak, having a lovely time and all, but there are certain restrictions on internet access!

Anyway……..the GMC guidance has arrived.

Most if not all doctors should have received an email from the GMC today regarding an update to General Medical Practice which is the code of conduct for all doctors registered in the UK. If you haven’t read it already you really should as it serves two major purposes in my opinion.

  • 1. It tells you what you should be doing as a clinician.
  • 2. It tells you what you should not do if you want to stay working as a clinician.

That may sound ominous but as doctors we hold priviliged positions in society and it is important that we behave in the best interests of our patients. So have a read, but in particular have a look at the explanatory notes regarding doctors use of social media as I believe that this is an area that worries many social media active docs, even those that I really repect like Jeremy Harrison.

[tweet https://twitter.com/resusdoc/status/316308832198471681]

One of the big changes will be that doctors are instructed not to use pseudonyms on social media types like twitter. This will mean a big change for many docs who prefer to separate the two. I took the advice of Mike Cadogan last year (@sandnsurf) that it is best to tweet with my real name as it can be traced back anyway and it you’re less likely to say something stupid if it has your real name attached. That works for me, but not for all people in this space and I suspect we will see some great contributors leaving (though hopefully they might return with real name intact).

[tweet https://twitter.com/GilulaArc/status/316305703302225920]

Thankfully and wisely the majority of the advice in regard to social media use is largely a reflection of the GMC’s advice in all other areas, though it recognises that the environment of social media means that new circumstances exist in which traditional principles apply, but where they might need clarification.

So, this is mostly a reiteration of old guidance re-organised to reflect social media environments and that’s fine. What is particularly important to me, and I think to many others are those areas where the relationships with patients might be compromised. Foremost here is the re-iteration of the rules around confidentiality.  They are worth repeating……

Maintaining confidentiality
12 Many doctors use professional social media sites that are not accessible to the public. Such sites can be useful places to find advice about current practice in specific circumstances. However, you must still be careful not to share identifiable information about patients.

13 Although individual pieces of information may not breach confidentiality on their own, the sum of published information online could be enough to identify a patient or someone close to them.

14 You must not use publicly accessible social media to discuss individual patients or their care with those patients or anyone else.

If you spend a lot of time communicating with colleagues in other health systems around the world you will soon realise that the rules with regard to confidentiality do differ depending on your area of practice and your local regulator and I see this is a potential area where UK doctors could get caught out. A look over my twitter timeline on any day of the week would find examples of international colleagues potentially breaking elements of the above and I can imagine that it would be all too easy to join in with a local patient story that strays across into a breach of confidentiality. In particular point 13 alludes to unintentional linking of information such as times and places that are often revealed through twitter. A common example might be ‘a patient has just walked in with X wrong with them’, in general it is pretty easy to work out who posted this, where they work, and what kind of work they do. All too easily it can then be linked to a patient and trouble ensues.

So what are we to do? Doctors and indeed all clinicians have used patient stories to teach and learn since the time of Hippocrates and we still do, though usually in closed spaces that are bounded by time and place (the traditional grand round for example). However, with the potential sharing of real cases in the social media space and even via the broadcast (webcast) of traditional meetings we do risk allowing what was once enclosed information to seep out through the porosity of social media, sometimes far beyond where it was first intended and with the potential to deliver harm to patients, relatives and colleagues.

What then?

Sir_William_OslerIt was William Osler (who knows a thing or two about teaching) who said

“To study the phenomenon of disease without books is to sail an uncharted sea,

while to study books without patients is not to go to sea at all.”

Well, like clinicians of old we feel that if cases must be used to deliver key teaching points (and they often are) then the way forward is for them to be created, imagined, developed and perhaps inspired by reality but that they should remain distant from the truth and not reflect people or circumstances that link them to individuals. Whilst this may arguably detract from the fidelity of any story it seems that this is the sensible and safe way forward for ourselves and colleagues who seek to improve patient care through social media. This is essentially the same process as writing for text books for publication. It is presumably fine to talk about typical presentations and circumstances but not in a way that risks revealing a person, time or place.

However, I am still a little concerned about the potential for misinterpretation and coincidence though. We had a case on St.Emlyn’s (non clinical) where a colleague thought that it was talking about them. It was not and but was in fact based upon a made up scenario, but like all the best made up scenarios it was believable – so believable in fact that it mirrored the identity of a different physician. This was entirely accidental and resolved quickly through professional conversation. However, such a co-incidence might be more tricky to manage with patients. For example if I started a case with…..

“A woman in her 20’s is brought to the ED following a fall whilst intoxicated. She has

fallen onto her outstretched hand and is complaining of pain in the wrist……’

Clearly there have been many such cases, you can also work out where I work, and I might associate an anonymised X-ray of a scaphoid fracture as an illustration to invigorate a blog post on imaging for occult wrist fractures. Could this land a blogger in trouble? There are two questions for me which are not covered in the guidance.

  • 1. To break confidentiality does the ‘patient/doc/colleague/relative’ have to notice or can such a breach be reported by others (important as there are people out there who might enjoy reporting bloggers).
  • 2. Is co-incidence a defence, because if it isn’t then I suspect William Osler might be spinning in his grave.

So, these are interesting times, with a range of media that might catch out the unwary. I also wonder if this is the start of a much wider debate, in days past the authorities found it difficult to silence the printing press, but in the meantime my advice is to think carefully before posting.

vb

S

‘Appy days’ – Medical apps at St.Emlyn’s

Smart phones and their associated stand-alone software applications, or apps, have become ubiquitous within the field of Medicine and perhaps, nowhere more so than the forward-thinking, technology embracing, occasionally geeky world of Emergency Medicine.  A survey in 2010 showed that 99% of medical staff had a mobile phone, and 81% of them used a ‘smart’ phone – figures that are unlikely to decrease any time soon. And crucially people don’t just have a phone, they have it within arms reach 24-7.

 

And, along with the smart phone technology, have come applications or ‘apps’. These little pieces of standalone software that run within the smart phone operating system and do everything from help you to find where you parked your car to take photographs like it’s 1977 (Ed – when I would have been watching the Fonz!).

 

Although individuals had written software for other hand-held devices such as the Palm Pilot, Apple was the first company provide the software and create a platform to facilitate writing and uploading programs for all software developers, from the bedroom amateur to multi-national companies. Crucially they also had a ready-made platform in the shape of iTunes, where hundreds of thousands of loyal users (with their associated bank details) found out how easy it was to download the apps onto your phone. Many of the apps are free, while most others are available for less then the price of a half-decent cappuccino.

 

A staggering 25 billion apps have now been downloaded from the Apple iTunes store from a selection of over 550,000 apps, generating revenue of over £2.5 billion for the developers.  Apps are also available for other brand phones with software available from Google, RIM, Nokia, Palm and Microsoft all having their own app stores for different devices, though Apple are far and away the market leaders with an estimated 80% share of the market. And, along with all the apps for essential tasks such as fighting zombies or choosing your sofa, have come the medical apps.

 

The medical app section is enormous and encompasses a huge selection of apps than run the entire gamut from ABGs to Zimmer Arthritis. Apple recently split the Health section into a Health and Fitness section and a Medical section but even this section remains enormous.  It’s also important to realise that the categorisation and descriptive purpose of the apps are still up to the software author. This is why you find the critical care apps jostling for space alongside the crystal care apps on the virtual bookshelves.

 

The available apps cover a wide variety of functions and purposes with variable degrees of utility and success. The best apps take advantage of the excellent memory, processing powers and graphics of these devices to perform functions so useful that you wonder how you used to live without them; other, more staid applications have cumbersome interfaces or simple replicate a text-book with four times as many pages as normal due to the tiny real-estate of the screen.

 

And so, as with any other category of apps, there are good apps and bad apps (crapps?) to which a natural selection process is applied. The good ones will be recommended by word-of-mouth or on-line reviews, the poor ones will be mercilessly criticised, or ignored. This process of peer recommendation works well for games or office utility apps but is not really good enough for apps in specialised fields such as medicine or aviation navigation.

While Apple have an approval process before an app will become available on their store, the purpose of this is to avoid code errors messing up anything else on your phone and also to make sure that there is nothing about your app that someone, somewhere may find offensive. What they do not do when you upload your app is check your qualifications, calculations or recommendations.

So, what happens if the writers of your app accidently advise you to use the amethyst instead of chalcopyrite, or put a decimal place in the wrong place in your drug calculation? Events at CERN and with the Hubble telescope have reassured us that even teams of the most brilliant international scientists can occasionally screw things up, so the odds of all 100,000 medical apps being completely error-free could be considered, at least, unlikely and some caution in applying… and that my friends is perhaps why the MHRA has decided to stick it’s oar in……!

 

Medicines and Healthcare products Regulatory Agency (MHRA)

 

In the UK, the MHRA has stepped into the breach to regulate the ever evolving and expanding universe of medical apps. This is a brave decision given the hundreds of thousands of apps that have already been downloaded millions of times (it could be argued that the bolting horses have already run off with the lid for Pandora’s box).

 

The first question to be asked is ‘what is a medical app?’ The MHRA have specifically addressed this issue firstly by distinguishing stand-alone software from software that is integral to a medical device.  So, the software in a medical pump would not be considered a medical device as it would be considered part of the pump, which is itself considered a medical device; software running on a phone that you use to calculate the pump settings, however, might be considered a medical device in its own right.

 

The MHRA guidelines from 2010 further define such as medical device by stating that ‘the software must facilitate some transformation of entered data, software that simply facilitates the storage and retrieval of patient data does not count as a medical device.’ So software that stored a patients blood results and then allowed retrieval of these results, would not be a medical device; but software that calculated an estimated GFR from the blood results might be. Or, software that stores an image and allows retrieval of the same image would not be a medical device, but software that manipulated the image or performed calculations based on it might be.

 

Or, if I read the calculation for acetyl cysteine dose for patients with paracetamol overdose on the College of Emergency Medicine website then this is not considered a medical device. If I then perform this calculation on the back of an envelope with a stubby pencil then these do not constitute a medical device. If I do my sums with a hand-calculator or even use the calculator app on my smart-phone then this does not constitute a medical device. However, if I write a piece of software that asks someone to enter the data then performs the calculation for them then this may be considered a medical device.

 

The guidelines then go on to state that the status of the software may depend on the qualifications of the person using it: ‘Decision Support software will generally not be considered a medical device if it exists to provide information to enable a healthcare professional to make a clinical decision. However, if it performs a calculation or the software interprets or interpolates data and the healthcare professional does not review the raw data, then this software may be considered a medical device.’

My interpretation of this is statement is that if an app has a disclaimer stating that it is only for use be a suitably qualified person who knows what they are doing, and then provides clear information about each calculation it is performing, then this may not need to be registered as a medical device.

However, European guidelines (which would also apply to the UK) from MDDEV in 2012, state that, ‘with respect to Decision Support Software, where the software is intended to provide healthcare professionals and/or users with recommendations for diagnosis, prognosis, monitoring and treatment of individual patients then it does qualify as a medical device.‘

The guidelines distinguish the ‘individual patient’ status to mean that if an app states ‘nobody should smoke tobacco’ then this would not constitute a medical device whereas an app that compiled data about Patient X and then recommended that ‘Patient X should not smoke tobacco’ would be a medical device.

 

So what is involved in registering an app with the MHRA?

 

Registering an app with the MHRA in order to get a CE mark of approval can be done for the fairly nominal sum of £70, (although this may be enough to dissuade the casual coder who already devoted a few days of his life hunched over a computer screen in an altruistic effort to save mankind) but what is actually involved in the process is less clear.

 

Most medical apps that perform some sort of data transformation related to the care of an individual patient would appear to qualify as Class 1 Medical Devices. This means that they need a quality assessment to be performed, but how and by who are not specified. There is also a mention that the assessment of quality may sometimes need to be conducted by a Notified Body, an independent company registered with the MHRA (or European equivalent) whose involvement adds very stringent quality control and several thousand pounds or more to the whole process. The requirement of a Notified Body assessment would therefore limit the application process to larger companies who would be willing /able to spend such sums.

 

I can only find one app that has actually received MHRA approval to date, the very helpful Mersey Burns app. This app, which aids in estimating the size of burns and then calculating any fluid requirements, is available for free so I would assume that it did not cost thousands of pounds to process. The associated website states that the authors have carried out their own quality assessment study to assess the performance, and have built in quality control checks for the calculator aspects that performs numerous self-checks calculations before proceeding with any user data.

 

I suspect that this app will be the first of many to be approved and as experience in this field grows, the rules and guidelines around this approval process will become easier to traverse.

 

It can be argued that this new layer of bureaucracy is necessary to prevent patients being exposed to the dangers from clinicians blindly following the advice of error-strewn apps, although this level of scrutiny has never been applied to textbooks.  People may also provide poor or wrong information or advice on websites without coming under the auspices of the MHRA but it appears to be the inclusion of calculations that triggers the need for regulation.

 

As is to be expected for such a fast-moving field, some questions remain:

  • Where is the line drawn between medical devices and non-medical device apps?
  • What happens to apps that are not MHRA approved?
  • Are apps from anywhere in the world subject to the same scrutiny before being released in the UK?
  • Will MHRA approval be required for the hundreds of thousands of apps that already exist and have been downloaded?
  • What form of quality assessment needs to be performed and who by?
  • Who is responsible if a medical error occurs as a result of using an app?

 

I have emailed the MHRA seeking clarification on these points and will hopefully provide an update when a clearer picture emerges.

 

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Craig Ferguson