Medical Software Quality: Ensuring Correctness in the Clinical Environment

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1 4/27/2015 Medical Software Quality Dr Ita Richardson Principal Investigator, Lero / ARCH Medical Software Quality: Ensuring Correctness in the Clinical Environment Ita Richardson, Louise Reid, Pádraig O Leary 1

Quality: Ensuring Correctness in the Clinical

2 Research Background Ensure correct management and maintenance of connected health systems Hospital Quality Assurance program (Reid et al., 2012) Evaluate the effectiveness by which the data is presented to health care professionals e.g. Presentation of data to health care practitioners (O Leary, Carroll, Richardson, 2014) Research Background Lack of interoperability hinders collaboration, usability and flexibility of connected health e.g. Establishing how to model care pathways so that we can develop connected health flows (O Leary, Noll, Richardson 2014) 2

Presentation of data to health care practitioners (O Leary, Carroll, Richardson, 2014) Research Background Lack of interoperability hinders

3 Research Background European Union regulation Focus has been in Ireland Software implementation in Hospitals Medical Devices and Software Software within Medical Devices Up to 70% of budget on software related activities 3

Medical Devices and Software Software within Medical

4 4/27/2015 Medical Device Software Software in Medical Device production lines Medical Device software Software manipulating Clinical data (Health Information Systems) 4

5 Analysis Published Research Medical Inquiries, Academic Research, Standards and Regulations (Medical and Software) Use of Software & Technology practice Participant observation, Study of Documentation, Interviews, Focus Groups, Workshops EU Directives.software in its own right, when specifically intended by the manufacturer to be used for one or more of the medical purposes set out in the definition of a medical device, is a medical device. 5

6 EU Directives 'medical device' means any instrument, apparatus, appliance, software, material or other article,., intended by its manufacturer to be used for human beings for the purpose of diagnosis, prevention, monitoring, treatment or alleviation of disease,. injury or handicap, FDA regulation an instrument, apparatus, other similar or related article, including a component part, or accessory which is. intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals. 6

7 FDA regulation Medical Device Data Systems (MDDS).. does not modify the data or modify the display of the data, and it does not by itself control the functions or parameters of any other medical device. MDDS are not intended to be used for active patient monitoring FDA regulation The quality and continued reliable performance of MDDS are essential for the safety and effectiveness of health care delivery. Inadequate quality and design, unreliable performance, or incorrect functioning of MDDS can have a critical impact on public health. 7

8 Hospital Information Systems Information systems used hospital wide Information systems used specifically by single departments Information systems are used personally by clinicians No integrated electronic patient record (EPR) Primary medical record is paper based Reid et al., 2012 / Reid, 2014 Results Healthcare needs to evolve with technology HOWEVER Clinicians do not understand: Quality Requirements in the Clinical Environment for use of technology Regulations regarding the development of software which includes excel and mobile phone apps Risk involved in manipulating data from a certified Medical Device 8

, 2012 / Reid, 2014 Results Healthcare needs to evolve with technology HOWEVER Clinicians do not understand: Quality Requirements in the Clinical

9 Manipulation of data from MDs App development and use 9

10 Use of Internet Use of Smartphones 10

11 4/27/2015 Security and Privacy Research Question How can we assure Medical Device and Software Quality in our Hospitals? 11

12 Hospital Information Systems Low understanding of IS quality by clinicians Requirements engineering processes are often not used during systems development Healthcare staff, not qualified in software engineering nor compliance, develop and implement systems Little emphasis is placed on data reporting even when data is available What steps can be taken? Awareness-raising through education and audits (H-QAP) Collaboration between software engineers and clinicians to enhance healthcare through technology Implementation of measures to improve system use 12

is placed on data reporting even when data is available What steps can be taken?

after inactivity Backup databases & files E-mail scanning system Shut down work machines out of hours 25/37

13 4/27/2015 Simple measures for improvement For systems in hospitals Virus software used regularly Network availability restricted Encrypt data on local machines / servers Encrypt data transferred (HTTPS) Automated timeout after inactivity Backup databases & files scanning system Shut down work machines out of hours 25/37 Hospital Policies Where regulation is required, only regulated Medical Devices (including software) should be used in the hospital 13

14 4/27/2015 References O'Leary,Padraig, Noel Carroll and Ita Richardson, The Practitioner's Perspective on Clinical Pathway Support Systems, IEEE International Conference on Healthcare Informatics (ICHI 2014), University of Verona, Italy, September 2014, pp O Leary, P., Noll, J. and Richardson, I., A Resource Flow Approach to Modelling Care Pathways, Third International Symposium on Foundations of Health Information Engineering and Systems, Macau. J. Gibbons and W. MacCaull (Eds.): FHIES 2013, LNCS 8315, pp , 2014, Springer-Verlag Berlin Heidelberg. Reid, L., Lotter, M., Burton, J. & Richardson, I., (May-June 2012) Designing and Implementing a Hospital Quality Assurance Program, IEEE Software, 29(3), pp , DOI: /MS Reid, L., Implementing a Hospital Quality Assurance Program, PhD Thesis, University of Limerick, Thank you Dr Ita Richardson ita.richardson@lero.ie 14

, A Resource Flow Approach to Modelling Care Pathways, Third International Symposium on Foundations of Health Information Engineering and Systems, Macau. J. Gibbons and W. MacCaull (Eds.

21 EU Partners distributed team environment Software Quality Plan played a critical role.

21 EU Partners distributed team environment Software Quality Plan played a critical role. Employing a Software Quality Plan within a Distributed Team Environment Dr Noel Carroll, Prof Ita Richardson 1 Overview TRANSFoRm (FP7 Project): to develop a rapid learning healthcare system driven by