Can Standards and Regulations Keep Up With Health Technologies? – new Viewpoint article in JMIR mHealth uHealth

Following the publication of their Viewpoint article (Open Access) in the Journal of Medical Internet Research, JMIR mHealth uHealth, CHI+MED researchers Chris Vincent and Katarzyna Stawarz from UCL’s Interaction Centre have written the blog post below to introduce it. The JMIR article was jointly written with their colleagues Gerrit Niezen from Swansea University’s FIT Lab and UCLIC’s Aisling O’Kane.

The article looks at the tension between patient benefit from and regulatory oversight for newer, innovative technologies using as examples 3D printing, customisable medical devices and smartphone apps.

The full paper can be read freely at the journal’s website, which also keeps a record of its popularity on Twitter, with a ‘Tweetations‘ (Twitter citations) tab.

Screen Shot 2015-08-03 at 13.07.43

© UCL Creative Media Services

New Viewpoint: Can Standards and Regulations Keep Up With Health Technologies?
3D printing, customisable medical devices, and smartphone apps are creating new opportunities for personalised healthcare and changing the ways people manage their health. Some of these new technologies are supporting a move away from hospital-centred care towards the home, increasing patients’ independence and helping to control the burden on healthcare providers.

Health related technologies: Brave new world?
There are many benefits to the above technologies, but changes in health management also create challenges in balancing the need for regulation (ensuring safety and performance) with the need to innovate flexibly. On one hand, putting in place checks to make sure that solutions work seems obvious. We all get annoyed when software fails to work in the way we need it to or gives the wrong results. In healthcare, the consequences can be serious, for example an app might incorrectly detect a cancerous mole which can cause unnecessary stress.

Although such accounts can be concerning, no one wants to delay the introduction of new technologies when people are likely to find benefits. It could be wrong to get in the way of new processes or technologies that are suitable but don’t yet fit in with existing approaches to regulation.

In our latest viewpoint article, Can Standards and Regulations Keep Up With Health Technology?, we discuss some of the challenges to regulating new types of health technologies. We give three examples of novel medical technologies (3D printed medical technologies, customisable medical devices and smartphone apps) that illustrate the types of issues that can arise and suggest opportunities for improvement.

Below we highlight some of the main points, but invite you to read the whole article.

Open hardware and 3D printed devices
Open source hardware is an increasingly popular way to create medical devices within the maker community. Although existing mechanisms of control might not fit well with the rapid turnaround that 3D printing technology provides, the benefit in allowing for a customisable prosthesis or bespoke medical devices is huge. By opening up the design documentation, and making it publicly available, not only can others benefit from a solution but they can also help to review it.


© UCL Creative Media Services

Medical devices and social interactions
Our article also examines the way that medical technology is evaluated in terms of social needs. Allowing customisation of a medical device can improve its fit with people and their surroundings. For example, changing the exterior shell of a device so that it looks less like a piece of hospital equipment and more like a consumer product, or adapting appearance to be discrete (or indiscrete, depending on circumstances) can make people feel more comfortable and at ease during many social situations. Usability evaluation processes don’t always accommodate these aspects and we discuss what could be done to address this.

Regulating smartphone apps
Finally, we discuss issues with regulating smartphone apps. As the number of available health apps is increasing, it becomes more difficult to decide which ones are suitable and what sort of evaluation is required. Although regulatory guidance has been updated to address this, using medication adherence technology as an example, it can be tricky to know when the device regulations do and don’t apply. As a result, such apps are more or less unregulated. We outline the confusion that can arise when following classification schemes and highlight the fact that developers often side-step the process through use of disclaimers. This makes this topic a difficult one to address and we give suggestions regarding an increasing need for in situ monitoring.

These are just some of the challenges that are introduced by new medical technologies. We hope our article is a starting point to bigger discussion.

Further reading
Can Standards and Regulations Keep Up With Health Technology? by Chris Vincent, Gerrit Niezen, Aisling O’Kane and Katarzyna Stawarz

Cite this paper as
Vincent CJ, Niezen G, O’Kane AA, Stawarz K
JMIR mHealth uHealth 2015;3(2):e64
DOI: 10.2196/mhealth.3918
The paper’s record on PubMed – PMID: 26041730

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FDA warns about cybersecurity re: hacking risk for hospital infusion pump

From the FDA’s Safety Communication updates (click to subscribe)

“Today [31 July 2015] the FDA issued a Safety Communication on cybersecurity vulnerabilities of the Hospira Symbiq Infusion System.

Hospira and an independent researcher confirmed that it is possible to access the Symbiq Infusion System remotely through a hospital’s network. This could allow unauthorized users to control the infusion pump and change the dosage it delivers, potentially leading to over- or under-infusion of critical patient therapies.

The FDA and Hospira are not aware of any patient adverse events or unauthorized access of a Symbiq Infusion System in a health care setting. Health care facilities can reduce the risk of unauthorized access by transitioning to an alternative infusion pump and implementing recommendations from the FDA Safety Communication.”

“The Food and Drug Administration said Friday it’s the first time it has warned caregivers to stop using a product because of a cybersecurity risk.” Modern Healthcare article

Further reading

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How to report a problem with a medical device, in the UK

Last night I went to see a screening of Casino Royale which, despite the violence and shoot-out mayhem, is fantastically good fun.

Without wishing to give away plot spoilers there’s a scene in which a life-saving medical device fails to work, for the very simple reason that one bit gets disconnected from another bit. Fortunately disaster is averted as someone is able to reconnect the bits in time – hooray.

There can be problems with devices for all sorts of reasons, and with medicines too. People might get the wrong dose (or the wrong medication) and it’s important to know that anyone can report a problem to the MHRA (the regulatory agency that handles medicines and devices) using the ‘Yellow card’ scheme which works for drugs or devices. You don’t need to be a doctor or healthcare professional to fill in a form.

More information at how to Report a problem with a medicine or medical device, with additional information for those in Wales, Scotland or Northern Ireland.

Here’s what the MHRA yellow card page looks like:


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Pharmacy legislation: Government consultation [closes 14 May] on learning from dispensing errors #ptsafety

“Encouraging pharmacy professionals to report, share and learn from mistakes improves patient safety through ensuring mistakes aren’t repeated.” – from the FAQ.

This is a Government consultation which will close on Thursday 14 May and is to do with community pharmacies (high street, not hospitals). It is about looking at ways of reducing the threat of criminal sanctions on pharmacists who inadvertently dispense the wrong item or amount. The reasoning behind this is explicitly to encourage pharmacists to be more confident in sharing, and learning from, errors – ie transparency. This seems pretty encouraging.

The relevant documents are on this page – Open consultation: Pharmacy legislation on dispensing errors and standards.

Some information excerpted from the FAQ is below:

Q – What does ‘rebalancing’ mean?
Rebalancing is about ensuring the right balance between Government legislation and professional regulation to ensure the safety of users of pharmacy services while encouraging responsible development in practice.

About the rebalancing programme
Q – What does the programme cover?
It is looking to address recent changes in pharmacy practise to enable pharmacy professionals to do more for patients and the public.

Q – What will it achieve?
Key outcomes include:
• a continuous focus on safety for patients and the public through learning from dispensing errors as a result of increased reporting of errors;

Why is this happening, and what does it mean?
Q – What does this mean for pharmacists and pharmacy technicians?
… A priority for the programme board has been to examine medicines legislation relating to dispensing errors. It recognises that the fear of prosecution for inadvertent dispensing errors affects the level of reporting of such errors, by pharmacists and pharmacy technicians, and therefore the learning from these errors.

Q – If we are relaxing the rules, won’t this lead to a fall in standards?
We are not relaxing the rules. By removing the threat of criminal sanctions for inadvertent dispensing errors, we are encouraging a culture which focuses on improving patient safety through more transparent reporting and learning from mistakes. Pharmacy professionals who are wilfully negligent or set out to cause deliberate harm will still face criminal prose-cution, as is the case with all healthcare professionals.

Q – When will you address dispensing errors by pharmacy professionals in hospi-tals?
[this seems to be under consideration]

Q – Why is criminal prosecution such a concern? Isn’t it right to protect the public? Are you opening patients up to additional risk?
Knowing that a mistake can result in a criminal prosecution doesn’t necessarily mean that patients and the public are better protected. It can lead the pharmacy professional to be wary to report dispensing errors because they would admit to a criminal offence by doing so.

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