Straight from the horse’s mouth – or where to go for verified information about #coronavirus or any other medical topics.

If you work in #digitalhealth it is important that you deal only in facts and validated information to retain credibility.

Over the past years, months and days, we’ve all been exposed to #fakenews in one form or another. Some of it is obvious and maybe even funny. Other fake news maybe less obvious, especially if it comes through a friend or colleague. #coronavirus has led to many fast circulating examples of misinformation so here is a quick guide to how to make sure you have up to date validated information and a list of specific #COVID19 resources.

We often don’t know where to go in the middle of so much available information. Newspapers often get their information second hand and report , as is their function, on ever changing situations early on. Blog posts can look surprisingly well referenced but if you go into the references maybe citing animal studies or non peer-reviewed articles. Did you know that many journals now ask authors to pay for their article to be published, knowing they have a willing market in researchers needing to publish a certain amount of articles a year?

Other sources of potentially biased information due to having vested interests are patient information webpages which appear at the top of google. Often pharmaceutical companies or pressure groups have invested a lot of money in making sure that their page appears first when you type in their name. It may take a while to find out who is behind the page – a red flag in itself.

So where should you look?

The best sources are official, have an obligation to be updated regularly and have been reviewed by someone other than the author. Looking at the site where the information is hosted is one of the first steps.

  1. .ac.uk – university sites in the UK
  2. .gov – official government sites
  3. .nhs.uk – the National Health Service in the United Kingdom
    1. NHS Patient Info
    2. NHS Specialist Info
  4. .org – if combined with it being the national college of a medical speciality, it should be a reliable if not always very easy to use source of specific medical information
  5. .edu – a educational institution which may be a university hospital with information for healthcare professionals and patients.

Clinical guidelines and updates are often published by national societies but there are also a few other places to look:

FDA: The U.S Food and Drug Administration website has a lot of regulatory information but also updates on current events such as donating plasma if you have recovered from COVID-19. Use the search option to find information about your topic of interest.

NICE : The National Institute for Health and Clinical Excellence is a UK based organisation on which clinical protocols are based. if you want to check what is the is the latest guidance on a specific health issue, including coronavirus, then this is a good place to start. Don’t be put off by the sometimes dense text, there is always a summary option available.

For research papers you can look at PubMed where almost all research papers are collated, with links out to the originals and links to other articles citing the information provided in your chosen article. You can specify how recent you want the article to be and whether you are interested in just humans or also animals. Using the “review” filter means that you will get an article looking at all the research on a particular topic. This can be very useful for the general public or non-specialists. You can also set up alerts so that you receive an email every time someone publishes something in your field of interest.

If you do receive a whatsapp or facebook message purporting to come from Stamford University for example, copy and paste the first line into google and you will quickly find out if it is a scam or not. Even videos with an MD explaining something may not be validated information. Always fact check anything you receive.

Specific COVID-19 or #coronavirus resources.

In view of the fast changing events it really is best to go straight to the horse’s mouth, or the specific #COVID-19 pages of the ones informing the experts and the general public:

  1. World Health Organisation
  2. British Medical Journal – Best Practise
  3. John Hopkins Coronavirus Dashboard.
  4. KnowledgeShare compilation of articles and guidelines coming out.

If you want to hear it from those on the ground.

Front-line health workers whether doctors, nursed or paramedics have taken to podcasts as the way of reflecting on their experiences and how it fits in with the evidence. They are ahead of the official guidelines especially in fast-changing situations such as the current coronavirus pandemic.

EMCrit – USA based emergency physician and guests.

The Good GP – Australian Family Medicine Doctors talk about their experiences and latest updates.

Emergency Medicine College explains how to deal with COVID19 for non-EM doctors.

Pondermed – talks about the reality for radiographers amongst other COVID-19 topics.

Paramedic podcasts – prehospital health workers are the first people on the scene and have a unique view on what actually works and is really going on.

Why your #healthtech pizza can’t have too many toppings.

Have you ever been so exhausted with making decisions at work that you decide you just want pizza for dinner (any pizza, as long as someone else decides the toppings)? This decision fatigue (1) is a very real experience for all types of doctors and health professionals who spend their day taking important decisions with life or death consequences immediately or in the future. There has even been a scale developed to assess how health professionals are affected by this (2).

So when you present your amazing healthtech product with its many multiple options to clinicians, don’t feel offended that their eyes glaze over, or even droop. It’s not a case of reducing your offer of special functions available exclusive to your digital health product. Instead, tailor your product to the needs of the health professional in front of you.

What you really need to do is to know which functions will change their practise, decrease their levels of frustration with IT and set it up for them. Of course, they can do it themselves (this and a few more complicated procedures such as saving lives), but if you do it for them, you get a foot in the door. Leave it to them, and it will be pushed to the bottom of the non-urgent pile, and that is how digital health products end up not being implemented.

You can rail against health professionals pushing back against tech, but the reality is that if it doesn’t work for them, you are going to be the one left on the outside.

1. Linder JA, Doctor JN, Friedberg MW, et al. Time of Day and the Decision to Prescribe Antibiotics. JAMA Intern Med. 2014;174(12):2029–2031. doi:10.1001/jamainternmed.2014.5225 

2. Hickman RL, Pignatiello GA, Tahir S. Evaluation of the Decisional Fatigue Scale Among Surrogate Decision Makers of the Critically Ill. West J Nurs Res. 2018;

 

Lost USB? Hacked? What to do in the case of a data protection breach?

Despite all the best will in the world and processes in places, data breaches can happen. It can be as simple as a lost USB with patient information or a more sustained hacking attempt which affects only your clinic or you as part of a wider organisation which has been maliciously attacked.

Informing the supervisory body.

The most important point is that you have 72h to inform the supervisory body as soon as you are aware of the breach as per Article 33. If you don’t do this within 72h, you must give reasons as to why this wasn’t done. The information you will need to provide is:

  • Nature of the breach:
    • Categories of data subjects
    • Numbers of data subjects.
    • Numbers and categories of data records affected.
  • Data protection officer contact details as well as those of other people who may be able to give relevant information.
  • Explain the potential consequences of this breach.
  • Explain what you have done so far and what you plan to do to mitigate the effects of the breach.

Informing the patient.

Once you have informed the supervisory authority, you need to notify the person whose data has been breached (data subject) in clear and plain language. As per Article 34, you do not need to inform the patient if:

  1. The data was encrypted or used other methods to ensure that it is unintelligible to persons not authorised to access it.
  2. The data controller has taken extra measures to ensure the risks of the data breach are not likely to materialise.
  3. It would involve a disproportionate effort. Public communication would be the alternative in this case.

If the supervisory authority feels that this is a high-risk situation and you have not informed your patient/data subject, they make take on the task of informing patients about the data breach and its potential consequences.

Why you need to clinically validate your #healthtech.

Quoted failure rates of #healthtech start-ups are almost as hysterical as the millions said start-ups are said to be receiving. Numbers vary vastly from 44% to 70%. The actual numbers don’t really matter (unless you are one of the investors or workers losing out), the real issue of how to avoid this happening in the first place in #digitalhealth. #Healthtech projects which have clinicians behind them do well both in the private and public sector; they have inbuilt clinical validation from the start. This is why you too should think about doing it. 

So that the #healthtech actually works.

It may seem an obvious point, but many digital health “solutions” fail because they are not in fact a solution. They are a product which is developed by non-healthcare professionals to answer a perceived need. Innovative technology is showcased brilliantly at industry events but then is either rejected or fails when it comes to the medical profession.

Bias in medicine is a dangerous thing, and as clinicians, we are continually being put in our places by patients who don’t conform to expectations. There has been much talk about Babylon’s diagnosing a woman as having anxiety instead of a heart attack, pointed out incidentally on #medtwitter. However, this is just one of many examples of bias which can mean that your non-clinically validate #healthtech not only doesn’t work but also becomes a liability. And as with Babylon, word spreads fast in the medical community. How many #healthtech developers are employing data scientists to look at potentially dangerous biases in their algorithms?

So that doctors support your #healthtech.

Lack of clinical take-up leads to a lot of “doctors will just have to get used to changing their practise whether they like it or not” comments, implying that they are stuck in their ways. This overlooks the fact that doctors, by definition, are lifelong learners, adapting their clinical practice on a daily basis. Every patient you see is a risk-balance assessment of what works best for that patient based on current evidence but also your own professional opinion. Healthcare professionals are your toughest critics because they are the ones who see the #clinicalreality and the aspects which you don’t. No man is an island and no patient is just one disease.

When you diagnose a patient, you do so not just by looking at a set of tests and variables such as heart rate, but by speaking and looking at the patient. The questions often seem random to a layperson, but sometimes the examination is even superfluous. I know I’m not the only person who has gone back into a cubicle to put a stethoscope on for the patient’s benefit as I’d already understood what was going on by the time we’d finished talking. Just how many #digitalhealth people realise that by the time you are ordering the tests, you are often just confirming the diagnosis. When you “treat” a patient, you do so not just following a protocol but based on many other factors.

However, there are many frustrations which we know technology could help with; having access to all the correct patient information, reducing the decision burden by incorporating protocols. So speak to your target clinicians. Now. Often. In their clinical setting. What they will tell you is that they will enthusiastically take on validated and evidence-based #healthtech which answers their needs. In fact, they will probably be able to tell you what you need to do to make your #digitalhealth technology work. Sometimes they have already done it themselves, and you can work with them.

So that patients go to their doctors asking for your #digitalhealth solutions.

And if you speak to the doctors, and nurses, and healthcare assistants, and receptionists, and porters, don’t stop there. Patients, especially chronic patients, have a very clear idea as to what works, what doesn’t work and which of their #digitalhealth needs aren’t being met. There is a whole #wearenotwaiting movement where type 1 diabetes patients have been going faster than the industry at developing openAPS or open artificial pancreas systems and glucose monitoring. After many years of being treated as dangerous mavericks, they are now being incorporated into paediatric diabetes care in major NHS hospitals. Even the fact that they are not FDA approved has not put off parents and doctors using them. That is what “disruptive” in #healthtech really means. Meanwhile, Medtronic and others who provide the “official” solutions, have recognised the fact that it makes more sense to employ directly the #wearenotwaiting developers rather than play catch-up.

Even patients who are not digitally savvy will be quick to tell you why they will or won’t use an app or technology. And often these are for very different reasons to the doctors. Maybe it is because they are more affected by the short-term side effects of a medication whose dose needs to be changed than targets- and they have to be able to access that information quickly. It may be that your amazing frailty support system doesn’t recognise the fact that being part of the #silvereconomy doesn’t mean being bedbound, and that they too want to go places in the world with no internet connection. Patients are whole persons whose disease lives with them once they leave the consulting room, and any treatment, digital or traditional, needs to take that into account.

So that you can expand into the community.

It is fair to say that in an era of influencers, traditional advertising is being rethought to reflect the age-old concept that you are more likely to follow the recommendation of someone you trust that the manufacturer. Doctors, suspicious as they are (!), prefer to hear about new medications and developments in medicine from other doctors. Pharmaceutical companies have long recognised this fact and this is another advantage of clinically validating your product. You speak the language of your target users, and once clinicians are prepared to listen, it can be a useful two-way conversation and is the way you get your #digitalhealth product to a clinical setting.

Patients too ask friends and family for advice. The reason that the instruction to only take medication which has been prescribed for you is precisely because people still take their family member’s medications for something which may or may not be a similar disease. Once you have patients with a vested interest, then others will follow. The way to do that is to listen, speak to and answer their needs.

It’s an exciting time to be in medicine, both as a professional and a patient or carer. It is in everyone’s interest in making sure that the progress in #healthtech works first time round….and keeps on working and being relevant.

Health data – How long can / should I keep it?

Whether you are a data controller deciding which data should be used or a data processor in charge of keeping the health data in the cloud for example, how long you you should keep data for is something you should be proactively thinking about. The general principle is that you only keep it as long as is necessary, which of course can be open to debate and also regional variations.

The purpose for which the data has been collected will help you decide how long to store data so that you are not exposing yourself to a data breach for longer than needed. If you are developing an app then that time should be specified clearly in the terms and conditions. When looking at health data, for individual patient treatment and diagnostics, the concept of “as long as is needed” could be thought, from a clinicians point of view, to be for the duration of the individual’s life. For research, it can be and is argued that the data should be kept beyond an individual’s life. Theses decisions are often taken by the organisation’s data protection officer or DPO.

WIth health data, as long as you still have some responsibility for that patient, and the patient has recognised it, then you can and should keep their health data. As ever it is up to you to make sure that it is accurate and up to date. This includes making sure that contact details are current. Once you have decided which data you are collecting, the amount of time you decide to keep it is the easy bit.

When can you (temporarily) skip the medical data protection?

Health data is by definition and function sensitive data, but as anyone seeing patients knows, it is not always practical to get consent when treating a sick patient.

It is not necessary to encrypt or anonymise patient data if:

  1. The patient as given express consent.
  2. It is in the vital interest of the patient, and the patient is unable to give consent. E.g., an unconscious patient arrives in the ER or if the patient is a minor.
  3. The professional processing the data to provide health care is already under a professional obligation to treat patients according to a code of confidentiality. This is the Hippocratic oath and all other versions which have followed.

When you do find out more information about, for example, an unconscious patient, you are under the obligation to update records immediately. Again standard practise for medical professionals before the GDPR was brought in.

It’s a short article because it’s a short message.

Don’t let the fear of data protection legislation stop you saving lives!

Sharing & transferring health data.

When you share patient data as a doctor, for example, referring your patient to a cardiologist colleague, you are ‘disclosing personal data’. You don’t have to disclose the transfer of the information to the patient or data subject if you are still respecting professional confidentiality. The receiver or recipient of this data then becomes the data controller with the inherent obligations.

Patients too have the right to take their data with them wherever they go, this is the right to data portability.

Apps are not covered by professional confidentiality. So any changes in who has access to or is processing the data have to be informed in full to the app user including the identity of the new app data controller, the categories of data which will be used and the recipients of the data among others. It is a long list, but how many people just click on the “updated terms and conditions” without reading them? Most of us…

Being based outside the EU does not exempt an app from complying with GDPR if the data subject or app downloader is based in the EU. So unless you are 100% certain that you are complying with GDPR you should limit your app store access to countries not covered by the GDPR.

If the data is being shared outside the EU (of particular interest in the context of Brexit), then similar levels of protection should be requested. Chapter V covers the transfer of data outside of the EU and clearly states that once the EU has decided if the minimum requirements are met, this has to be reviewed every 4 years. It is the European Commission who decides if the standards are being met

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.

GDPR and fitness apps.

Do you own a fitness tracker? Or even just activate the steps counter on your phone?

Most of us have used some sort of health or fitness app, whether to go running or record more intimate details. Most of us have also ticked all the terms and conditions automatically. To comply with GDPR, the information should be clear, and the data collection limited to what is needed by the app. Is geolocation and access to your contacts always necessary? How do you feel about your age and gender combined with your fitness level being shared with undisclosed third parties? While medical data for clinical trials usually have to be anonymised, this is not necessarily the case for your data which is then shared with your insurer or your mortgage broker…without you even knowing it. This is when the targeted ads for new running shoes pale into insignificance. Higher health insurance premiums or rejected mortgage applications have a real impact on our life.

As a doctor, you will be the controller of the fitness data of the data subject, who is your patient. In the context of fitness trackers, you need to be sure that you comply with Article 5, being especially mindful that the data you collect is limited to the specific healthcare purpose. As apps can often collect a lot more data than you would imagine, as a doctor and controller, you need to be sure that you don’t end up collecting everything indiscriminately. This same data can make it unexpectedly easy to identify patients even if you remove the distinct identifiers such as name, age and gender.

Personal data is any data that can identify you as an individual and more specifically, health data is anything that refers to your specific health status. Furthermore, this is classed as sensitive data as the consequences of this data becoming more widely known can have more serious implications as previously mentioned.

If you are integrating the information from an app as part of an EHR program you have contracted, this is one of the questions to ask the EHR seller. How do you ensure that only relevant information is brought across? This is something they may not even have thought about.

If you are incorporating the information in a report format generated by the app that the patient has sent you by email for example, then just make sure you have a copy of preferably written consent. It should cover the data being incorporated into their EHR and therefore, everyone else who also has access to the EHR.

Although fitness trackers can be a good way of getting people or your patients to a better state of health, you may want to have a chat about “free” trackers. Some health insurance companies are offering almost free fitness trackers. However, they then access your data and premiums may be affected by how the health company evaluates your fitness and therefore, your risk for future illness. They might not turn out to be so cheap after all.  There are many less expensive if less prestigious fitness trackers on the market. In reality, most people only need an activity monitor and heart rate monitor. The ECG monitoring option has been controversial and may not be relevant to your patient. It is a fast changing industry and clinical need rather than opportunity should be the dictator as to whether you incorporate a fitness tracker or other wearable into your practise. It is important to think if the information provided is useful or will potentially lead to more testing as with the incidentalomas (incidental imaging finding) which appeared when full body CTs became available. Just because you can, doesn’t mean you should!