AR in medicine. The future?

What is augmented reality in medicine?

Augmented reality, or AR, is a relatively new technology in which a computer-generated image is superimposed on the user’s vision of the world.1  To create this augmented reality, hardware such as headsets, smart glasses or mobile devices are used. The difference with virtual reality is that the user keeps a link to the surrounding physical world.1

Augmented reality has many uses in medicine. These include medical training, especially anatomy but also simulation training. Surgeons can use AR to plan surgery, and all physicians can use AR to explain complex situations to patients and their relatives.2

Diagnostics

In diagnostics, AR has been used to improve adenoma detection rate. A combination of computer vision algorithms and a large database of colonoscopy polyp images means the endoscopist gets real-time visual assistance. Images are overlaid on the primary monitor they are using or on an adjacent monitor.3

Therapeutics

Therapeutics is another area where AR has been extensively used, especially in rehabilitation. The interactive aspect means that patients are encouraged to improve their motor actions.4 For people with severe mobility issues, including the elderly and paralyzed, AR becomes an integrated part of their daily life as part of a home appliances system. AR interacts with brain-computer interfaces to give back patients a degree of autonomy.5

When ultrasound was brought in, a new 2D perception of a 3D space was needed. Anyone who has ever used an ultrasound knows that this involves retraining your way of looking at spaces in what I felt was initially counterintuitive.  Ultrasound-guided biopsy is a minimally invasive procedure for tumour staging. Still, it requires long training not only on a manual technique level but also taking into account the change in perception of space. AR is used to plan the trajectory of the needle and then execute the process. A robot arm with pressure sensors is used, feeding back high-quality information to the operator. The person undertaking this ultrasound-guided biopsy is then able to overcome any needle deflection or target motion.6 

Training

Anyone who has taken a basic or advanced life support course will remember meeting Resusci Annie, the rubber mannequin used to simulate emergency situations. Although a great resource for many years, there was never any doubt that you were dealing with a floppy doll. High fidelity simulation training uses complex mannequins who can breathe, have a variable heartbeat and affect ECG readings which take training to a level. The ultimate challenge is simulation training with a real person, but there you are limited to one hopefully stable pathology, and obviously, you can’t administer medications or electric shocks. When it comes to training in anatomy, there are financial, ethical and supervisory constraints on the use of cadavers.7

You also can’t see inside the body, and this is where AR takes medical training to a whole new level. One setting is airway training, where learning to intubate often means switching between the student and instructor who attempts to explain what they are seeing and how best to proceed with the tube. In surgery, AR laparoscopic training too has been shown to increase trainee skills, especially when combined with physical models.3 This freedom of sight is also a safety aspect.8 In addition, AR means the training can take place in a professional work environment, undertaking real tasks. Depending on the program used, this training can be independent without the need for an instructor to be constantly there.7 Emergency medicine training has already been done remotely using AR as distances can be a real issue in more remote clinical settings.9

There can be some disadvantages. Sometimes trainees find that AR can lead to dizziness or blurred vision, although less than with VR or virtual reality.7 Cost is another consideration, although this may be less important to students and institutions who see the skill gain as non-negotiable.

How soon will AR come into my practice, and how should I prepare?

Google Glass was the forerunner of easy access VR and which some considered being low-level AR. Some of you may have tried out these glasses in a non-clinical setting. Google Glass is a good entry-level AR due to the familiarity of the concept. Many of us already use normal eyeglasses. The first version is now obsolete, but the 2020 revised version has been launched with an increased facility for developers to build their own software.10 Now more than ever, as a practising clinician, if you think of a solution for an everyday frustration, you can approach developers to build it for you. The hands-free aspect in a sterile or semi sterile environment is an attractive proposition for situations where you need access to information but don’t have the staff, such as in primary care. Being able to easily scan patient records without the need to be looking at a computer all the time would in itself make a lot of patients and doctors happy.10  In the same way as AR has helped with polyp identification in real-time, external dermal or other lesions too will be superimposed with AR and the corresponding algorithms and knowledge databank.

However, machines, like humans, are not infallible and knowing where they may fall down leads to using them more safely. Although some authors claim that AR will be trained to see with fidelity and without bias, bias in algorithms is only now starting to rear its ugly head.3  There have been several high profile cases of algorithms misidentifying people of colour in facial recognition programs.11 The algorithm will only ever be as good as the input data, even if the data is extensive in quantity. Humans choose the data which will be used, and we all have our own unrecognized biases. Hidden or unidentified health inequalities are often a direct result of these biases, whether race, age or other.

Physicians may be concerned with privacy issues. In cultures where scribes writing down the notes are usual practice, the idea of someone doing the same thing remotely as you use google glass or another similar device may not be a problem.10 For other clinicians, this may take a bit more getting used to. The developers need to think like a doctor, like all doctors, to overcome resistance. Perhaps some clinicians prefer to have limited options, not all of them. At least at the beginning.

What do patients think about it?

It’s very hard to know what patients think of their doctors using AR. There is a lot of information available projecting on to patients what they should be thinking and how they should see improvements. Yet this may not be the reality. We need to ask them and listen. Specific AR therapies have good outcomes as defined by the study researchers, but you don’t know what you don’t know. Perhaps dizziness may be too much of an issue, or perhaps there are other side effects or worries which have yet to be voiced. As with telemedicine, these reticences can often be overcome once the real underlying worries are identified.12

So what now?

AR is one more technology that will come to the patient interaction. It’s only a matter of time. Like POCUS, point of care ultrasound, there will be fans and detractors. Individual knowledge and training are the keys, as is listening to patients. Even if you don’t like it, your patient may have heard about great outcomes for their specific condition. Or you may be encouraged by the increased safe prescribing options of AR but find that you lose patient engagement, and much as the course of antibiotics is not finished, the AR stays in the box after the first couple of days.

If you’ve had any feedback or have any thoughts on VR or AR from your patients or yourself, I’d love to hear from you. @alice_bbyram on Twitter or email me abyram@ab-health-solutions.com.

1.        Tang, S. L., Kwoh, C. K., Teo, M. Y., Sing, N. W. & Ling, K. V. Augmented reality systems for medical applications: Improving surgical procedures by enhancing the surgeon’s “view” of the patient. IEEE Engineering in Medicine and Biology Magazine 17, 49–58 (1998).

2.        Eckert, M., Volmerg, J. S. & Friedrich, C. M. Augmented Reality in Medicine: Systematic and Bibliographic Review. JMIR mHealth and uHealth 7, (2019).

3.        Mahmud, N., Cohen, J., Tsourides, K. & Berzin, T. M. Computer vision and augmented reality in gastrointestinal endoscopy. Gastroenterology Report 3, 179–184 (2015).

4.        Yeo, S. M. et al. Effectiveness of interactive augmented reality-based telerehabilitation in patients with adhesive capsulitis: protocol for a multi-center randomized controlled trial. BMC Musculoskeletal Disorders 2021 22:1 22, 1–9 (2021).

5.        Park, S., Cha, H. S., Kwon, J., Kim, H. & Im, C. H. Development of an Online Home Appliance Control System Using Augmented Reality and an SSVEP-Based Brain-Computer Interface. 8th International Winter Conference on Brain-Computer Interface, BCI 2020 (2020) doi:10.1109/BCI48061.2020.9061633.

6.        Freschi, C. et al. Ultrasound guided robotic biopsy using augmented reality and human-robot cooperative control. Proceedings of the 31st Annual International Conference of the IEEE Engineering in Medicine and Biology Society: Engineering the Future of Biomedicine, EMBC 2009 5110–5113 (2009) doi:10.1109/IEMBS.2009.5332720.

7.        C, M., Z, Š., A, R. & A, S. The effectiveness of virtual and augmented reality in health sciences and medical anatomy. Anatomical sciences education 10, 549–559 (2017).

8.        D, P. & K, M. Current Perspectives on Augmented Reality in Medical Education: Applications, Affordances and Limitations. Advances in medical education and practice 12, 77–91 (2021).

9.        Munzer, B. W., Khan, M. M., Shipman, B. & Mahajan, P. Augmented Reality in Emergency Medicine: A Scoping Review. Journal of Medical Internet Research 21, (2019).

10.      TriHealth invests in Augmedix Inc.’s Google Glass health care venture – Cincinnati Business Courier. https://www.bizjournals.com/cincinnati/news/2016/04/25/trihealth-invests-in-groundbreaking-google-glass.html.

11.      Raji, I. D. et al. Saving Face: Investigating the ethical concerns of facial recognition auditing. AIES 2020 – Proceedings of the AAAI/ACM Conference on AI, Ethics, and Society 7, 145–151 (2020).

12.      Healthwatch England. Locked out: Digitally excluded people’s experiences of remote GP appointments. (2021).

13.      Liu, Y., Stiles, N. R. B. & Meister, M. Augmented reality powers a cognitive assistant for the blind. eLife 7, (2018).

14.      Kulkov, I., Berggren, B., Hellström, M. & Wikström, K. Navigating uncharted waters: Designing business models for virtual and augmented reality companies in the medical industry. Journal of Engineering and Technology Management 59, 101614 (2021).

Research methods in innovation.  

Types of research – a deep dive into case studies.

Quantitative

Quantitative research uses a statistical interpretation of, among others, observational data using predetermined methods. It is the type of research that is most published by medical journals but is by no means the only one.

Qualitative

Qualitative research is more used in the social sciences but is also relevant in medicine, especially to innovative projects. With qualitative methods, the questions are more open-ended, and data arrives in a less structured format. Interview data, documents, and audio-visual data are all used to bring out themes, patterns, and interpretations. As a clinician, you can immediately see how qualitative research is relevant to medical projects. Patients are more than a list of blood test parameters or diagnoses. This type of data represents not patients, but people with fluctuating disease, positions in society and their families, and a reality that we know is fundamental to understand for any therapeutic intervention to succeed. When innovative projects fail, it is rarely to do with the technology itself, but because these “non-clinical” factors are not taken into account.

One of the research methods used in qualitative research which you may have come across is case studies. In 2006 Flyvbjerg published an interesting paper about case studies and popular misconceptions or even negative attitudes towards them.1. I will go over these misunderstandings because you may find you also had these misconceptions without realising them.

  1. Theoretical knowledge is more valuable than practical knowledge. This refers to how people learn. Yet experts become so by working on many case studies. A fact recognised by Harvard since the 1980s when case study based learning was introduced. Kuhn argues that “a scientific discipline without a large number of thoroughly executed case studies is a discipline without systemic production of exemplars…and a discipline without exemplars is an ineffective one”. Thus, Kuhn concludes that social sciences need more good case studies. I would argue that this also extends to innovation in digital health and medicine generally.
  2. One can not generalise from a single case, the single case study cannot contribute to scientific development. To refute this argument, we need go no further than Galileo’s rejection of Aristotle’s law was based on a conceptual experiment and only later, if at all, on a practical one. Even if he did actually carry out the experiment, it is controversial that he used the leaning tower of Pisa to demonstrate that objects fall at the same speed, independently of their size, as Aristotle had previously argued. No RCTs were carried out to prove this. Case studies can be used to generalise the type of test that Popper called ‘falsification’, a clear-cut test he illustrated with the ‘All swans are white’ example. Popper said that if only one swan were to be black, the proposition would be false and needed further investigation. Flyvbjerg uses this to argue against the misunderstanding that case studies can not be used to generalise by identifying case studies as a method of identifying ‘black swans’ because of the in-depth nature of case studies.
  3. The case study is most useful for the generation of hypotheses – other methods are more suitable for hypotheses testing and theory building. This misunderstanding is based on the previous premise that you can’t generalise. So, if that is invalidated, this misunderstanding too is invalidated. Flyvberg maintains that although useful for generating hypotheses, case studies can also be used for other parts of the research process. It is also true that atypical or extreme cases often reveal more information.
  4. The case study contains a bias towards verification. Understood as a tendency to confirm the researcher’s preconceived notions, the study, therefore, becomes of doubtful scientific value. Bias is something inherent to all researchers, no matter what method they use. Even Charles Darwin developed his own method of recognising this ‘I had . . . during many years followed a golden rule, namely, that whenever a published fact, a new observation or thought came across me, which was opposed to my general results, to make a memorandum of it without fail and at once; for I had found by experience that such facts and thoughts were far more apt to escape from the memory than favorable ones. Owing to this habit, very few objections were raised against my views, which I had not at least noticed and attempted to answer.’ Case studies have their own but different rigour of methods which means researchers using the case study method have been led to change their initial hypotheses. Indeed, in other methods, the subjective bias may be across many cases rather than one without being challenged.
  5. Often difficult to summarise specific cases studies. This final misunderstanding which has been used as a criticism or limitation, is for the fans of case studies a sign that the study has uncovered a particularly rich problematic for which a summary is not desirable. Nietzsche explains, ‘Above all,’ he says about doing science, ‘one should not wish to divest existence of its rich ambiguity’ (emphasis in original).

The choice to use a case study is often because it allows multiple and emergent data collection methods.2

Mixed methods – the best of both worlds!

Mixed methods use both predetermine and emerging methods from a pragmatic point of view. Multiple forms and levels of data are used which include both statistical analysis and text analysis. Critical interpretation across databases is obtained, bringing together the different research traditions to benefit the patient. So, if you have an idea for a research project or your innovation throws up a question that doesn’t fit neatly into a box or method, perhaps it doesn’t have to. Mixed methods are, for me, the best way of looking into the reality of patients as people and, therefore, what makes them tick.

Lessons to be learnt from qualitative research methods and the social sciences.

  1. The importance of categories.

Although we may be aware of obvious cut off points such as age which has led to many trials excluding a large proportion of the population, there are other aspects to the categories you may choose when researching innovation. Applying a category gives power to the person deciding the categories, especially if it is imposed. Choosing to associate with a category may give back the power to the participant, but you have to be clear that this inherently gives legitimacy to certain viewpoints. And silences. Putting someone in a category is an action of power, but so is the ability to remove a person from a category. If you think about yourself, you might not want to be always classed as an iPhone user, or as an iPhone user to all the people you meet. It is a frivolous yet serious example if you start thinking about other categories you are placed in, such as hypertension, marital status, and weekly alcohol intake.

Age is a tightly coupled category, but some categories may be more transient, such as mental status and have real implications on access to certain services or stigma. When you want to capture or even market to innovation users, taking into account the categories you choose and the people you silence is vital.

2) Logics of inquiry

There are generally three logics of inquiry or ways of thinking about the research you wish to undertake or have been undertaken. Again, being aware of these will make you recognise your own biases and find the line of inquiry best suited to your innovation.

An inductive line of inquiry starts bottom-up with the people’s own subjective interpretations. These lead to questions and hypotheses to investigate, which in turn are confirmed or refuted. The end product of an inductive inquiry is a theory. You may well find yourself taking this approach based on your experience with an innovative product and experience.

A deductive approach is top-down, that is existing empirical work gives a set of statements. The researcher then applies the hypotheses and generates a new hypothesis or question.

Finally, the abductive line of inquiry is driven by a social phenomenon. It tries to explain why something is happening now and in what way. Here the researcher looks to find common processes.

How do you know which study is good?

Most medics are used to doing critical appraisals of scientific journal articles. Everyone has their own method, but for those who aren’t used to doing this, the Oxford-based CASP team have a checklist you can work through. If you are interested in hearing how clinicians debate these papers and the questions, try the Resus room papers podcasts—all links are in the podcast notes.

Suppose you are thinking of presenting research or presenting information. In that case, you can assess your own work before going in front of the lions with the PROMPT criteria in which presentation, relevance, objectivity, method, provenance and timeliness are all looked at. The PROMPT criteria are as relevant for researchers as for marketers and innovators coming up with a new idea. If you know the criteria your audience or buyers are using, you can prepare yourself better.

Finally, when you get involved in a discussion about research, recognise when what you see is “ad hominem”. A critique is directed at the person producing the research rather than the work itself, attacking the messenger, not the message. “Ad hominem” attacks are especially relevant as regards COVID research in areas such as vaccinations and face coverings where emotions run high.

What sort of research is needed in innovation?

Why?

Research is due diligence by another name, especially in the early stages. Further down the line, it can be seen as auditing or market research systematically. You are probably already doing it but perhaps not with the best tools.

Who by?

Yourself. As just mentioned, you are probably involved in some sort of research, whether you realise it or not. You can also outsource to people who have already published on the matter. They may be interested in collaborating, and at the very least, can direct you to others in the field. A quick search in PubMed can lead you to the people you need. Perhaps, you need to think outside the box and go to social scientists rather than traditional medical researchers. Social scientists may have a research approach more suited to the world of innovation in digital health and other spheres where mass RCTS or randomised controlled trials can’t be carried out. You can find these researchers in the sociology department of any university, and many will already be crossing over with psychology and other health sciences. There is a loss of knowledge when people research in geographically different spaces. You only need to look at the canons of Arabic medicine being reinvented and “rediscovered” in the Middle Ages in Europe. It is still going on when those involved in healthcare don’t look at what is happening in spheres that are not scientific as per their understanding of the concept.

When?

So, when do you need to do the research? Early on is the answer. Or at least it is important that you think about the potential research your treatment or innovation can lead to so that you collect all the data you need, following GDPR, of course. A retrospective study, looking at data collected previously, may not be as prestigious as a RCT. However, as we have seen, if you know the limits of each research method, it can still be valuable.

Another option is if you are aware of the ongoing multi-centre trials, you may find something you can jump on. For example, if you have a point of care blood coagulation device, you may want to look at centres that are taking place in the CRASH-4 trial. On their website, they explain ‘the CRASH-4 trial aims to provide reliable evidence about the effects of early intramuscular TXA on intracranial haemorrhage, disability, death, and dementia in older adults with symptomatic mild head injury.’ Prehospital knowledge of blood coagulation may well be incorporated into later treatment algorithms for mild head injury. Talking to those involved in this type of research gives you a foot in the door to a specific clinician population who have a special interest in haemorrhage.

Take home.

Different research methods have their uses, perhaps more than we have previously thought when it comes to case studies.

Learning from the social sciences and using mixed methods can fill the gap in innovation research and implementation.

Remain critical of the research and yourself. You are already a researcher with bias, whether you realise it or not.

Innovative medical devices on their own are not enough. They need to be validated and integrated into the health system and the lives of patients.

Resources.

Five Misunderstandings About Case-Study Research. Flyvbjerg B

CASP Critical appraisal checklists.

Resus room podcasts discussing papers.

PROMPT criteria.

1.        Flyvbjerg, B. Five Misunderstandings About Case-Study Research: http://dx.doi.org/10.1177/1077800405284363 12, 219–245 (2016).

2.        Paparini, S. et al. Evaluating complex interventions in context: systematic, meta-narrative review of case study approaches. BMC Medical Research Methodology 2021 21:1 21, 1–22 (2021).

Sorting the wheat from the chaff. Choosing a digital health app.

Why use a digital health app?

With more than 90,000 digital health apps being added in 2020 alone, physicians are bombarded with download options as much in their professional life as in their private life.1 However, not all apps are equal, with the top 110 apps accounting for almost 50% of all downloads.1

So why use a digital health app? It might seem like an obvious question, but like anything related to screens, it is important to think about apps in a meaningful way. Especially in a professional context. The answers to the question include convenience, safety, and extended knowledge. Or do they?

The days of the trainee carrying around a well-thumbed Oxford handbook are over. Now the entire Harrison fits into your phone and then some. However, I’m sure that I’m not the only one who has excitedly downloaded a textbook to never look at it again. The format of the information needs to be easily accessible in a clinical context. Sometimes you need to know the pathology exists to look for it. In a book, you can thumb a few pages forwards and backwards and, serendipitously, come across the diagnosis.

You also need to be able to personalise your reference tool, adding to it as you go along. Whether it is a dedicated notebook or lines in the margin, many clinicians add local protocols, bleep numbers (yes, they still exist), or extra tips learnt along the way. Often this can take form in a digital form of a notes document on your phone.

There is also the credibility aspect of checking a written text in front of a patient. Somehow looking up a dose on a phone is not the same as checking a paper format. Having said that, no one will argue with the fact that a doctor cannot memorise all the medical conditions and drug dosages. Having a digital memory aid, especially when tired, can be a question of safety.

Another argument favouring digital health apps is that they can easily extend your knowledge to any area for which you can download a protocol or handbook. For non-dermatologists, there is a wealth of image banks with or without artificial intelligence to aid diagnostics. Of particular note is Malone Mukwende’s Mind the Gap project with St George’s hospital in London to reduce the health disparities in diagnosing skin pathologies in people of colour. Of course, providing an online platform of images that can be updated is not the traditional definition of a digital health app. Still, it is arguably one of the platforms which will have the most impact. And the app will surely follow.

However, no doctor is an island and conversations between different specialities, whether family medicine and oncologists, further everyone’s knowledge. An app can never replace an interactive discussion about the best treatment for a specific patient, taking into account the available local resources, patient preference and social context, and preferred outcome. Indeed these conversations often lead to recommendations of more specialised resources. In this day and age, these recommendations often include health apps. Anaesthetists have been at the forefront of apps and are particularly good at knowing which apps are best for drug dosage or retrieval. Family and community medicine physicians often can point you to aids to avoid pharmacological interactions or diagnoses that span various organ systems. Physicians use a lot more health apps than you might think. And the ones they use will be the ones that work. If you have any that you would like to recommend, please send them to via Twitter @alice_bbyram or email. This brings us to the question of validating apps and knowing which ones are safe to use in your daily practice.

What do clinicians need to consider when choosing a digital health app?

When you do decide to use a health app, there are several aspects you need to think about before you start using it. First of all, is the device you will be using it on. Whether it is a personal or professional phone or computer, the memory needed for the app may affect the speed your device runs at. All portable devices should have a remote wipe and automatic delete after several unsuccessful login attempts.2 Of course, if the hospital computer is constantly updating windows XP or the websites are blocked by generic hospital controls, there is a natural selection as to which digital resources you have access to anyway. Similarly, suppose the app is a hybrid version that needs online access to give you all the information you need. In that case, you may find yourself limited by the WIFI available at your hospital or health centre.

            The individual using the apps or digital resources needs to recognise their own limitations. Few physicians receive formal digital health training, which is particularly important for prescription-only FDA-regulated digital resources.2 There is no shame in recognising that we have been washed along with the tide of innovation and haven’t any time to stop and steer our own course. This self-knowledge is fundamental when you consider how much health care professional input is required by the app. Some diabetes apps require quite extensive physician input.1

            Much has been made of the advantages of digital resources in aiding both physicians and their patients, with evidence available supporting the inclusion of digital health tools into health pathways. However, independent organisations caution about the need for more in-depth and long-term research to get a true picture.1 Physicians have a history of being cautious when sold new products by pharmaceutical representatives, for example. Digital health solutions are no different, especially when free. If the product is free, you’re the product as was so aptly demonstrated in ‘The Social Dilemma’.3 It is a valid question to think about who has the resources to set up and maintain a digital health resource.

Compliance and regulatory controls are mandatory for certain types of digital health rather than wellness apps. Still, you have to be aware that being American HIPAA compliant may not mean that an app is also compliant with European GDPR. The focus is different as the GDPR are person-centred, whilst the HIPAA regulations are arguably more focused on the business that deal with health data. You need to make sure that the regulations align with your personal requirements and beliefs around health data.

            National societies provide their own guidance. The Royal College of Physicians, for example, clearly states that you should not use web apps that don’t have a CE mark.4 And it is also up to the individual physician to make sure that it is up to date. Indeed, the college cautions against about being lulled into a false sense of security if you see a CE mark and has produced a fact sheet to help you decide whether you can feel confident about using a certain app.4 Even then it is up to the individual physician to exercise professional judgement when using the app. If you do see any calculation errors you are under obligation to report it to the MHRA.

            Digital formularies provide a library of available apps which could be held to a higher standard than an app store. The NHS has such a library of apps that have been passed according to the DTAC or Digital Technology Assessment Criteria for health and social care. This is a good starting point when you want to find an app covering a specific condition. However, users should be mindful of a possible increased cost due to exclusivity deals or newer and potentially better apps being excluded.2

            Finally, physicians are the end-user testers and are in a unique position to identify issues that come up. There is a professional obligation to flag up any prescribing or other issues that may impact patient care, but there is also the possibility of making a real change.5 Just as Dr Mukwende did with his dermatological diagnoses for people of colour, if you identify a need you can approach the innovation department of your hospital. Barcelona is a hotbed of digital health innovation, and places like the Barcelona Health Hub are spaces where digital health solutions are found by linking clinicians and tech companies.

What do patients need?

As physicians, we all know the need for medications to be easy and practical to take, and if not, the patient will understandably find it difficult to feel engaged. Digital health resources are no different. If an app takes up a lot of phone memory or is not easy to navigate, it will be quickly deleted. Conversely, integration with wearables such as smartwatches may lead to greater compliance. Word of mouth is also important amongst patients, and once one person sees the advantages of an app, others may well follow.

            Yet digital health technology can lead to exclusion. In fact, you may not even be aware of the exclusion your patients are facing. Sitting in a doctor’s waiting room recently, I saw a granddaughter teaching her grandmother how to read text messages to make sure she didn’t miss health care appointments. Now that, in some countries, appointment letters are no longer routinely sent out, you may not be aware of the level of patient exclusion. Specifically, newer methods for accessing appointments were found to be the place where most patients gave up.6

            Healthwatch UK found that exclusion can be linked to a lack of digital skills, affordability and trust concerns.6 However, it also found that statements about reluctance to use telehealth should not be taken at face value as once barriers are overcome, patients may be happy with telehealth options.6

Developers listen up!

When it comes to developing a new app you may have been commissioned by a physician who has seen a gap in the market or by a team who come from a more business background. The end-user is still the same. Patients and physicians along with their team, their family, carers, nurses and other health care assistants or HCAs.

Diabetes, mental health and life style change apps are all well established, but have you thought of patients with AIDs, chronic pain and infectious diseases? Also be reactive to what is going on around you. During the COVID pandemic there have been spikes of related apps peaking with each wave.1

The first step as an app developer is to consider what is needed, rather than what you can offer. Your expertise may lead to many functions but if they are not useful in day to day medical and home usage, the app will be quickly deinstalled. Consider also the accessibility and ease of use. Stay up a night or set an alarm every 3 hours to reach a sufficient level of tiredness and you can start to get into the skin of a physician or carer on call. If you use glasses, hide them somewhere in your house that you can’t find just when you need them most. If you don’t use glasses, borrow some to get that sufficiently fuzzy vison that many people have to deal with. Then reconsider if you app design still works.

Overcoming the reluctance of end users is a team effort, right from the start. Not just relevant to the sales team. As a developer you have to make sure that your app is secure by design and complies not only with country wide compliance laws such as HIPAA or GDPR, but also institutional ones such as in the NHS. Go straight to the end requirements that the physicians and patients will be requesting. The NHS Digital Technology Assessment Criteria for health and social care has an entire section on the requirements which should direct your development. These include clinical safety, data protection, technical security and interoperability criteria. To make your life easier as a developer there is tick box exercise for you to work through to make sure you are complying with good practice by design. Apps need to be accessible to all, follow ethics guidelines. From a technical point of view, you need to be up to the IEC 62304 international standard. Your app must undergo verification, validation and load testing as part of the development process. Bias testing is another aspect for which you may need to seek outside expert help. Humans are notoriously bad at recognizing their own biases.

            In the UK the Caldicott guardian principles are the benchmark for physician decisions when it comes to data protection. This is more likely to be used by physicians than the GDPR which post Brexit will be incorporated as UK-GDPR.  

Physicians are under obligation to report to any problems with an app which may lead to error to the MHRA depending on where they are practicing. You need to provide an easy feedback form to make sure you are also informed and react proactively rather than defensively.

You should be aiming for the CE mark whether the app will be free or not.5 and make sure that you have thought ahead how your health technology may evolve but also how the requirements may also evolve. If you are thinking of expanding to different markets, knowing in advance where the security emphasis is placed is invaluable.

Similarly, looking at the digital formulary of apps you may wish to be included in can help you overcome potential problems of being sidelined for not being updated or outpriced, a couple of the potential disadvantages of digital formularies.7

Finally, we’re all patients or carers/family of patients. So take off your designer hat and ask around you what works in an app. If you are working with a specific condition, speaking to the patient associations for people with that condition will not only help your design but also open doors whilst you are doing it.

In a nutshell.

  • Compliancy may come in many different forms – always use professional judgement on any decision taken.
  • Knowing who is behind the app can help you make decisions and even offer feedback.
  • Practicality has to come first be that automatic updates, storage use, interoperability and hybrid options
  • Think of possible patient exclusions to the digital health option you are offering
  • If you develop an app that is intended for use in any medical context in Europe, it will need a CE mark, whether it is free to download or not.
  • Knowing the criteria used for regulatory compliance can help you as a clinician decide if it is an app you feel safe using.
  • If you see a need be reactive and either develop the digital health resource yourself or go to the people who can help you or take it over.

In short, digital health resources are valuable, not necessarily an intrusion. When used mindfully, they can be a help, not a hindrance in your practice.

References

1.        Kern, J. et al. Digital Health Trends 2021. Digital Health Trends (2021).

2.        Gordon, W. J., Landman, A., Zhang, H. & Bates, D. W. Beyond validation: getting health apps into clinical practice. npj Digital Medicine 2020 3:1 3, 1–6 (2020).

3.        Orlowski, J. The Social Dilemma. (Exposure Labs, Argent Pictures, The Space Program, 2020).

4.        Royal College of Physicians. Using apps in clinical practice. (2015).

5.        RCP issues new guidance on using medical apps | RCP London. https://www.rcplondon.ac.uk/news/rcp-issues-new-guidance-using-medical-apps.

6.        Healthwatch England. Locked out: Digitally excluded people’s experiences of remote GP appointments. (2021).

7.        Gordon, W. J., Landman, A., Zhang, H. & Bates, D. W. Beyond validation: getting health apps into clinical practice. npj Digital Medicine 2020 3:1 3, 1–6 (2020).

Data protection for app developers & large organisations.

You may think that ensuring compliance with data protection in a large organisation is even harder than in a smaller clinic. However, it can be the complete opposite as you may find yourself having to appoint a Data Protection Officer (DPO) who takes over this role. Whether you need to do this or not will depend on the conclusions of a Data Protection Impact Assessment (DPIA) as per Article 35.

The use of new technologies such as EHR or health apps combined with large quantities of sensitive data such as in the case of a hospital means it is necessary to carry out a DPIA following the advice of a DPO. It is the data controller (doctor or other in charge of the data) who has to instigate this.

Data processors too have to think about a DPIA and if you are developing a health app this means you also have a responsibility:

When appointing a DPO, whether in the context of a larger clinical setting or app development, you can use the same DPO as other establishments as long as you easy access to that person. They can be part of your staff (and potentially fulfil other functions). You must communicate who your DPO is to the supervisory authority.

Even if a DPO is appointed the data controller is still required to record all the processing activities.