ORCHA

26/07/2023

We're delighted that our CEO will be speaking at on 26-27th September at ExCeL London. Register for your free pass to join the event https://eu1.hubs.ly/H04Hk-Z0

21/07/2023

👷🏼‍♀️What is needed to be a clinical safety officer (CSO) and how do I find one?

👩🏼‍⚕️The clinical safety officer (CSO) needs to be clinically trained, so they need to have a current valid registration as a healthcare professional. For the DTAC, the CSO needs to have undergone appropriate risk management training. For example, at ORCHA, our Medical Director and CSO is Dr Tom Micklewright.

📝Some organisations that offer clinical safety risk management training can also supply clinical safety officers (CSO) to help set up a process and maintain it.

🏠So, you can hire a CSO, or have your own in-house CSO who is a registered clinician that has undertaken the training.

📜Ideally the CSO will have expertise in the clinical area that your health app helps with, for example a diabetologist could identify risks, when you develop your health app, if it helps people with diabetes.

🌟Find out the answers to the top 5 questions developers ask us about the NHS Digital Technology Assessment Criteria (DTAC): https://eu1.hubs.ly/H04xqR00

20/07/2023

🤔📱💻How do you assess my health app so it meets NHS DTAC clinical safety standards?

🔎At ORCHA we look at the documents you have in place, and the people you have involved in the development of your health app (Android, Apple (iOS) or web-based app).

📋We assess your health app against the standard DCB0129, which is an NHS standard you need to pass to be used in NHS organisations.

💡You will need to share 3 specific documents and keep records internally for your processes.

📝These 3 specific clinical safety documents include:

1️⃣Clinical risk management system – this outlines your organisational safety processes, so who is involved, what training they have had, any process you have for auditing your platform and any third-party platforms that fit into it.

2️⃣Clinical safety case report – this talks specifically about your app in scope. So what is it, what does it do, what is the intended use and what testing you have done. This includes if you have done any clinical safety tests to look for risks. And if you have done testing, what were the outcomes? And finally, has this report been signed off by a relevant clinical safety officer (CSO)?

3️⃣Hazard logs – Each app you develop requires a hazard log, which records any risks to patients that may arise from use of the app. The likelihood and severity of these risks must be recorded, as well as any control measures you will put in place against these risks.

🌟Find out the answers to the top 5 questions developers ask us about the NHS Digital Technology Assessment Criteria (DTAC): https://eu1.hubs.ly/H04xqFD0

19/07/2023

🤔What if I don’t have documentation for NHS DTAC clinical safety standards, including those that show compliance with DCB0129?

💡Clinical safety standards documentation, including those that show compliance with DCB0129, are your assurance that what you are doing doesn’t lead to unmitigated risk to patients.

📝If something were to go wrong, you can point to these documents to demonstrate that you did everything you possibly could to mitigate the risks of that in your health app.

📆This is why it’s important to understand at an early stage what the risks are for using your health app and how you can mitigate them.

👩🏼‍⚕️Your clinical safety documentation should be passed over to the NHS organisation that will commission your health app, and they will then do their own risk assessment of your health app, including the use of your health app within clinical practice.

📋By having independent external validation, for example through ORCHA checking your documents, this helps you prepare for important conversation with NHS organisations when they want to commission your health app, so it is used in the most safe and effective way. This means that your health app will be used by the people and for the purpose you intended.

📈Another benefit of getting help in preparing your documents ahead of any procurement, is that we can speed the process up and reduce the risk of gaps or problems being flagged at crucial points in contracting discussions.

🌟Get the answers to the top 5 questions developers ask about the NHS Digital Technology Assessment Criteria (DTAC): https://eu1.hubs.ly/H04yFZ70

18/07/2023

🚥Your could soon have a "quality score label" that shows:
✔️If it's healthy and safe to use
✔️How easy it is to use
✔️How secure data is
✔️How robust the build of your app is

📢Now is YOUR CHANCE to have a say in how this will be rolled out!
➡️Take the free survey here: https://eu1.hubs.ly/H04xnrM0

📱This is part of a project by Label2Enable, who are developing a new ISO standard for health apps.

🌟Get ready for the new ISO standard here: https://eu1.hubs.ly/H04xnvf0

📨Contact Dr Anna Frey anna.frey@orchahealth.com if you have any questions

18/07/2023

🤔Is the NHS DTAC only for medical devices?

📖The DTAC asks if your health app is a medical device, and if it is then you need to provide the appropriate registration details and documentation.

🗣️If your health app is not a medical device, then you need to explain this too.

💡We do find that some health apps are in fact medical devices, and they may be unaware that they are. We encourage them to go through the medical device regulations appraisal process independently, such as the ISO4971.

💻📱The DTAC covers all digital health products (including health apps), whether they are or aren’t a medical device, and you need to evidence this in either case.

📋And part of the DTAC process is complying with standards such as the DCB0129, and others such as the ISO4971 if your health app is a medical device.

🌟Find out the answers to the top 5 questions we get asked about the NHS Digital Technology Assessment Criteria (DTAC): https://eu1.hubs.ly/H04xlXn0

17/07/2023

👩🏼‍⚕️👨🏾‍⚕️Mobile Health Apps Can Be a Valuable Tool for Healthcare Providers and Patients, But Regulation Issues Persist in the U.S.

3️⃣KEY TAKEAWAYS
📱More than 330,000 mobile are now available to consumers, and two out of three healthcare providers surveyed say they can help improve care management and clinical outcomes.

📋The Digital Health Assessment Framework (DHAF), launched a year ago by ORCHA, the American Telemedicine Association, and the American College of Physicians, is a set of standards by which mobile health apps can choose to be certified at present.

🤝This DHAF rating system is designed to give consumers more confidence in using apps and providers more confidence in prescribing them, while weeding out dangerous and ineffective apps.

📰Read more from Liz Ashall-Payne, CEO at ORCHA: https://eu1.hubs.ly/H04xQ_w0

🛡️Want to assess your app against the DHAF? Email us at hello@orchahealth.com

Liz Ashall-Payne, the founder and CEO of ORCHA, an international effort to establish digital health standards, explains why mHealth apps need a rigid rating system to gain widespread acceptance.

17/07/2023

🥁 It's time fooooor... 🌟 APP OF THE WEEK 🌟

👩🏻‍💻 Emily, one of our fantastic Digital Health Assessors has chosen:

📱 Squeezy (an NHS app)

🎤 Emily said, "Developed by specialist chartered physiotherapists, this version of Squeezy encourages the self-management of pelvic floor dysfunction and incontinence and serves as an exceptional example of how can improve health outcomes.

People who use Squeezy have access to an evidence based exercise plan with visual and audio prompts that they can track adherence to, in line with their personal target.

This app is an effective tool that transforms the way women understand the fundamentals of their pelvic health.

There is a squeezy app for men too, and both Squeezy apps rank in the top 6 medical apps on the Apple App Store."

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🏆 Every week we pick an app that has passed an assessment against standards and regulations in

✅ Clinical assurance and safety
✅ Data and privacy
✅ Usability and accessibility

🚥 Want us to assess your app?
Email us at hello@orchahealth.com

17/07/2023

📱🤔Why do I need to check my health app meets DTAC clinical safety standards?

💡You need to identify and check your health app has mitigations in place for any risks that could harm a patient’s health.

📆Do this as early as possible when you develop your health app and use this process as a road map for development.

✔️It can highlight how to improve the usability of your health app for the benefit of your users: patients or healthcare professionals.

‼️Otherwise, it is difficult to go back and make changes to an established health app.

📋Here are some examples of risks we’ve identified in health apps during a DTAC assessment:

🔵Signposting to a resource that is no longer available, and the patient not having access to that in a time of need
🔵Entering a number that is not flagged as ‘outside of an acceptable range’, such as an insulin dose or body temperature
🔵Data that is entered and processed in a way (data migration) where it doesn’t end up in the right place, for example it doesn’t identify a patient correctly
🔵Important data that is not included in a patient’s record, which could affect a diagnosis or treatment decision, such as recent prescription or allergy

🌟Find out the answers to the top 5 questions we get asked about the NHS Digital Technology Assessment Criteria (DTAC): https://eu1.hubs.ly/H04xmT-0

12/07/2023

📱76% out of 2000 people surveryed in the US started using a because of:

👨‍👩‍👦18.8% - friends and family
💻18.1% - own research
👩🏾‍⚕️17.1% - pharmacist
👨🏾‍⚕️15.3% - hospital doctor
👩🏾10.7% - nurse
🏥6.5% - primary care provider

📖Get our FREE report: https://eu1.hubs.ly/H04jGKk0

10/07/2023

📱79% of 2000 people surveyed said they want , such as , to be part of their lives to support their wellbeing
🗣️Find out more in our FREE report: https://eu1.hubs.ly/H04jGKT0

05/07/2023

📱Out of 2000 people in the US, more than 1 in 2 people want a 👨‍⚕️👩🏾‍⚕️healthcare professional to recommend a to them
🗣️Find out more in our FREE report: https://eu1.hubs.ly/H04jGK80