Inderjit Singh NHS England Health Apps #mHealth


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Inderjit Singh NHS England Health Apps #mHealth

  1. 1. Health Apps Indi Singh NHS England 29-4-14
  2. 2. Health Apps 2 - Why mHealth? - Why Health Apps Library? - Where next?
  3. 3. Health Apps 3 • Even the simple stuff.. • Worldwide market penetration of mobile phones will rise from 61.1% in 2013 to 69.4% in 2017. • NHS 111 received 891k calls in February 2014 • Even the simplest of applications, SMS, has a huge role to play. • Apollo Hospitals Group (India) use SMS as part of an integrated diabetes management programme to help people monitor their diabetes. • Orange Healthcare system in Kenya, Cameroon and Ghana that allows verification of medicines to combat the huge rise in counterfeit pharmaceuticals
  4. 4. Health Apps 4 • These simple applications are the tip of the iceberg. • Infrastructure already there.. networks, billing engines and the app industry are. • The number of mobile health apps continues to exponentially increases- nearly 100,000 mHealth apps already available across multiple platforms such as iTunes, • In January 2014, nearly 1/3 of US smartphone owners, which is about 46 million unique people, used fitness and health apps and the number of people using wearable devices to self-monitor or track their health, including Fitbit which has over 3.3 million users
  5. 5. 5 “Where do I find health apps that can help me” “How can people find my app easier” Citizen App Developers “I want rigour in the review process” “Don’t need another app store” “Don’t just want to pile it high” “Supplemented but not just based on patient ratings” “Don’t just want any app included” “Are these apps safe?” “Don’t want an overly cumbersome process” Clinicians “Would like somewhere to be able to signpost “ “Not valuable if not safe” Apps for the public – what the users said? 5
  6. 6. Health Apps Library 6
  7. 7. Health Apps Library 7
  8. 8. Health Apps Library 8
  9. 9. Health Apps Library 9
  10. 10. Health Apps Library CategoriesHome App Detail Review Process App Stores Submission Form 10
  11. 11. App Submission process Step 1. Submit – Developer submits an app Step 2. Initial triage Apps Team review the supplied information to check what the app does Step 3. Clinical Review Safety Engineer and Clinicians review the app where required. Step 4. Yes or No The app is approved and published or rejected due to not meeting our criteria Step 5. On-going Review The app listing is reviewed on a regular basis and if a user flags concern to us Critical step in the safety process - An initial triage checklist is completed on each App and it’s function. Does it pose any harm to patient safety? If Yes to Step 2 – Safety Assurance is required. Evidence of compliance with the Safety Standard – ISB0129 11
  12. 12. App Triage - Is the App a Medical Device? • CE marked? • functions include control or monitoring of a Medical device? • response time is time critical to patient care? The review process has been structured in a way to determine an Apps function, type of service it delivers. First and foremost – Section 1 of HSCIC triage process aims to establish whether or not an App is eligible to be a medical device. Where ISB0129 does NOT apply as the App is a Medical Device. Example questions from the triage checklist in order to determine if the App falls under the requirements of a Medical Device. Note: Answering yes to one or more of the above suggests the App may be a medical device (or a part of). Seek MHRA advice 12
  13. 13. App Triage – Categorisation of App Function? Triage Section 2 - Establishing the categorisation of the software / function e.g.: • Informational application? • Calculation and / or monitoring application? • Transactional application, to support booking appointments or repeat medication.? • Decision Support application? Look to clarify if an App falls under requirements of ISB0129 Clinical Risk Management: It’s Application in the Manufacture of Health IT. 13
  14. 14. App Triage – Applicable to ISB0129? Yes • provides Clinical decision support based on user input for treating or diagnosing a specific disease or disorder • integrates with other Health IT systems • is a transactional system (e.g. supporting appointment booking) When safety assurance is required under ISB0129. Example question from the triage checklist. E.g. Apps providing, access to the patients GP Health IT system, medication dosage calculators, prescribing. 14
  15. 15. App Triage – Applicable to ISB0129? No • if the App is NOT integrating with other Health IT systems • solely automates general office functions to assist in payments and billing etc • performs calculations / monitoring of general health and wellbeing with no Clinical support • provides information from a reputable organisation E.g. Healthy life style apps that presents information to the user, or user records and monitors own diet, weight. 15 When safety assurance is NOT required under ISB0129. Example questions from triage checklist.
  16. 16. What is required under ISB0129 • Risk Analysis • Risk Evaluation • Risk Control • Delivery, Monitoring and Modification Note: Clinical Risk Management runs throughout lifecycle 16 Manufacturer’s evidence of ‘Clinical Risk Management’
  17. 17. What is required under ISB0129 17
  18. 18. Apps Figures 18 174 34 38 Total Apps Submissions 246 Approved Invalid submission Outstanding 150 24 Approved Apps Safety assessments (174) ISB 0129 Not applicable ISB 0129 Compliant
  19. 19. Breakdown of apps 19 0 20 40 60 80 100 120 140 160 180 App Submission Tiage - Not Safety Triage - Sent for Safety Analysis Approved by the Clinical Safety Group Clinical Safety Approval not required Under review Total 176 142 34 11 17 6 Health Apps 32% 50% 18% App Compliance Approved by the Clinical Safety Group Clinical Safety Approval not required Under review 81% 19% ‘App Submission’ – Safety versus Not Safety Tiage - Not Safety Triage - Sent for Safety Analysis
  20. 20. Where next? 20 Move from informational only apps to a set of transformational apps aligned to key health priorities Online Care Planning for Dementia integrated with GP system Online Test Results and Care Planning Supporting Older People and Carers Supporting Older People and Carers Supporting Young People with Sexual and Mental Health Internet Radio App GP appointment Booking/repeat meds Online Redbook for new parents Online Care Planning for Long Term Conditions integrated with GP system
  21. 21. Where next? - PHRs 21 Clinician GP Clinical systems GP Clinical system APIs PHR Patient access online services through GP system patient portal or app Patient portal app Patient portal Patient portal app app app app Acute Clinical Systems Patient provides information into a PHR and associated with clinical information sourced from multiple points Secure transmission to user Secure transmission to clinical system Clinician Social Care app app app Carer can access patient information and also enter information
  22. 22. Summary 22 Focus on supporting patients in managing their care Focus on clinical safety Future is in enabling “integrated apps” Apps part of the patient journey @mr_indisingh