mobile Apps and mobile Devices Safe to Use?

Transcription

1 mobile Apps and mobile Devices Safe to Use? John Amoore Consultant Clinical Engineer

2 Reflections on current health care systems

3 Health care challenges: Hospital view Rising front door demand Patient flow through hospital Discharge planning blocked Input Emergency Dept miss targets, not coping with demand In some areas < 80% of patients seen within 4 hours Staff under pressure Resources limited Patients: seeking healing, People: seeking health DREAMS Care in the community Person-centred care Output Failure to discharge. Patients awaiting discharge still in hospital 1216 beds blocked each day across NHS Scotland, winter

4 Two views of current health systems 1. Royal College of Physicians (UK) Hospitals on the edge? The time for action (2012). A system on the brink Future Hospital (2013): person-centred care, Care to Patient, not patient to care point. 2. President s Council of Advisors on Science and Technology (PCAST) (USA) Better Healthcare and Lower Costs: Accelerating Improvements through Systems Engineering (2014) - Waste - To improve: Use systems approach Reproduced from: Royal College of Physicians. Hospitals on the edge? The time for action. London: RCP, Copyright 2012 Royal College of Physicians. Reproduced with permission.

5 Lessons from these reports 1. Royal College of Physicians (UK) - Person-centred care, - Take Care to the Patient 2. PCAST (USA) - Better care at lower cost is achievable - Person-centred care is key - Redesign using systems engineering tools - Harness Technology, in particular ehealth

6 What do we want from health systems?

7 What are health systems seeking? Patients responsible for their own health Care in the community Person-centred care IHI TripleAim Health of a population Experience of Care Per Capital Cost Reference: Institute for Healthcare Improvement Better care, Better health, Affordable

8 Drivers for change How to meet increasing demands, increasing expectations? Where are solutions being sought Person Centred Care Hospital without walls Care in the community Technology and Innovation Vision 2020 c.f. Health Education England Strategic Framework

9 Does technology have answers? It is not technology for the sake of technology. Health care is person centric Technology is not the answer, not the aim; but can its application help deliver answers?

10 Focus on communication Technology has changed communications empowering individuals Call the operator Direct dial Mobile phone Smart phone My Health Ask operator to place call for you Direct dialing! Phone anywhere in world directly From anywhere To anywhere. But also has intelligence, has information Much more than a phone Apps. Controls Communications Can mobile medical technology empower personcentred care?

11 Mobile technology: what does it offer? Mobility - Yes. But more! Freedom, Control, Independence Gives functionality and control to individuals, meeting their needs, where they are, when they need it

12 Terms we need to be familiar with mhealth: mobile health health care delivery via mobile devices uses Information & Communication Technology Mobile Medical Apps (MMAs): Software programmes running on mobile platforms (smart phones, tablets) to support health care mdevices: mobile medical devices Mobile devices that enable the delivery of mhealth Software applications on mobile platforms Conventional medical devices.e.g. Vital signs monitors

13 The Opportunity Mobile technology Widespread availability Powerful Harness its power for health care Freedom to innovate Encourage radical thinking Encourage culture changing

14 Mobile medical apps (MMA) Remote monitoring Healthcare information Collect clinical information remotely Remote diagnosis Targeted advice Healthy living advice Care in the community Remote therapy Pharmaceutical advice Mobile health care

15 Regulation Regulation an enabler Not a prohibiter

16 Mobile medical apps: threats Freedom brings risks Lack of control Limited Unclear Regulation Virus and other malware Patient data confidentiality Consequences Wrong Anxiety advice Poor human usability Quality of care Lack of evidence undermines quality and safety Buijink et al Medical apps for smartphones: Evidence based medicine.

17 Three Categories Regulation for safety (FDA) Unregulated Wellness focused Apps (e.g. exercise trackers; simple heart rate monitors used for fitness training programmes) Enforcement discretion Simple professional calculators (e.g. Measure and calculate mean arterial pressure; assess Glasgow Coma Score) Specific advice to patients (diabetes, hypertension) Regulated If they could harm patients if faulty. then they are Medical Devices, (FDA, Mobile Medical Applications, 2015) (Similar MHRA advice 2014) Regulation process - as for other medical devices

18 PAS 277: 2015 (PAS = Publicly available specification) Health and wellness apps Quality criteria across the life cycle Code of practice Defines quality criteria for developing, testing and releasing of health and wellness apps - covers full project life from development through updating Addresses fitness for purpose, risk management and monitoring of usage Supports innovative-solution development Does not cover apps classified as medical devices 5 th May 2015

19 ensure: Freedom to Innovate ensure: Quality and Safety Guiding principles Appropriate regulation Clinical oversight Regulation and Standards If regulated: CE mark If not regulated: Standards PAS 277 Approved lists, peer reviewed facilitating hospital and physician recommendations kitemark for health apps (NHS, Nov 2014) Approved lists e.g. NHS Choices health apps library ( c.f. Approved lists of BP devices from professional organisations (BHS, dable) Professional organisations: e.g. Digital Health and Care Alliance

20 Discussion and Conclusion To ensure safety To encourage innovation

21 Patient and Carer Experience Keystone model Focusing equipment and patient and carer planning together Map the equipment journey Map the patient journey Brooks-Young and Amoore, 2012 Person centred care The Keystone, The focus Remembering the focus, the equipment s purpose - Innovate - Be prepared to change - Flip healthcare

22 To ensure safety Buy right Regulated? Is it a medical device CE mark Validated? Kite mark, approved lists, professional societies Standards? can these help Selection - Consider users? Ergonomics, Human Usability Use right Abraham N. Can we gain without the pain? Controls Assurance Conference 2000, Hammersmith Hospital, London, June Operational support Home users Hospital users Software security Data protection Malware protection Maintenance software and hardware ehealth + Medical Physics

23 Better use of data and technology has the power to improve health, transforming the quality and reducing the cost of health and care services. Personalised Health and Care 2020 Using Data and Technology to Transform Outcomes for Patients and Citizens. A Framework for Action National Information Board, NHS England, November