Reuse of data from smart medical devices for quality control and evidence-based medicine

The use of smart, software-based, networked devices is clearly becoming a major trend in future healthcare. An important factor for the adoption of medical grade devices in clinical practice and for cost reimbursement from insurance is the proof of their medical efficacy. There are formal conditions for approval, set by the respective authorities. However, even clinical trials are of limited value, as such devices act as complex Cyber-Physical Systems, that is, they interact intensively with the varying environment and are dependent on numerous humans who have various skills and mindsets. Due to software upgrades, the devices evolve themselves. Therefore constant monitoring of their behavior is necessary. Fortunately, these devices produce an immense quantity of data that beyond assuring direct patients’ care, can be reused for quality assurance and medical research. Ideally, this process should be supported by open platforms for system integration and data exchange. In the real case, we have to make it a common goal for various stakeholders with differing interests. Among the potential technical problems we can name, privacy protection is one that can be reasonably assured by a blend of technical and organizational measures. Another one is data analysis, which, due to the constantly evolving conditions, is a challenging problem.

[1]  Stuart J Pocock,et al.  Current challenges for clinical trials of cardiovascular medical devices. , 2014, International journal of cardiology.

[2]  Timothy J. St. Cyr.  An overview of healthcare standards , 2013 .

[3]  G. Gigerenzer.  Risk Savvy: How to Make Good Decisions , 2014 .

[4]  Shayne C. Gad.  Safety Evaluation of Pharmaceuticals and Medical Devices: International Regulatory Guidelines , 2010 .

[5]  Kevin Fu,et al.  Controlling for cybersecurity risks of medical device software , 2013, Commun. ACM.

[6]  Jörg Carlsson,et al.  Herzschrittmacher- und Defibrillator-Therapie: Indikation – Programmierung – Nachsorge , 2006 .

[7]  Salah Abdel‐Aleem,et al.  Design, Execution, and Management of Medical Device Clinical Trials , 2009 .

[8]  Enrico Coiera.  Guide to health informatics , 2015 .

[9]  D. Lazer,et al.  The Parable of Google Flu: Traps in Big Data Analysis , 2014, Science.

[10]  Yue Guan,et al.  The Angelina effect: immediate reach, grasp, and impact of going public , 2013, Genetics in Medicine.

[11]  Gordon H Guyatt,et al.  Epistemologic inquiries in evidence-based medicine. , 2009, Cancer control : journal of the Moffitt Cancer Center.

[12]  Charmont Wang.  Sense and Nonsense of Statistical Inference: Controversy: Misuse, and Subtlety , 1992 .

[13]  V. Stodden,et al.  Privacy, Big Data, and the Public Good: Frameworks For Engagement , 2014 .

[14]  James L. Hargrove,et al.  Dynamic Modeling in the Health Sciences , 1998, Modeling Dynamic Systems.

[15]  Steve Warren,et al.  Applying the ISO/IEEE 11073 Standards to Wearable Home Health Monitoring Systems , 2005, Journal of Clinical Monitoring and Computing.

[16]  Aaron S Kesselheim,et al.  Regulating incremental innovation in medical devices , 2014, BMJ : British Medical Journal.

[17]  Hermie Hermens,et al.  A framework for the comparison of mobile patient monitoring systems , 2012, J. Biomed. Informatics.

[18]  Peter C Wyer,et al.  Where is the wisdom? I--a conceptual history of evidence-based medicine. , 2009, Journal of evaluation in clinical practice.

[19]  Dieter Speidel,et al.  Quality Assurance in the Age of Mobile Healthcare , 2014 .

[20]  Terry Young,et al.  How many testers are needed to assure the usability of medical devices? , 2014, Expert review of medical devices.

[21]  Xiaojiang Du,et al.  Security for Wireless Implantable Medical Devices , 2013, SpringerBriefs in Computer Science.

[22]  B. Schneier.  Liars and Outliers: Enabling the Trust that Society Needs to Thrive , 2012 .

[23]  S. Stanley Young,et al.  Deming, data and observational studies , 2011 .

[24]  Ruud ter Meulen,et al.  Evidence-based practice in medicine and health care : a discussion of the ethical issues , 2005 .

[25]  Jan Sliwa,et al.  Wireless sensor and actor networks: e-Health, e-Science, e-Decisions , 2011, 2011 International Conference on Selected Topics in Mobile and Wireless Networking (iCOST).

[26]  Álvaro Alesanco Iglesias,et al.  On the Seamless, Harmonized Use of ISO/IEEE11073 and OpenEHR , 2014, IEEE Journal of Biomedical and Health Informatics.

[27]  Toon Calders,et al.  Discrimination and Privacy in the Information Society - Data Mining and Profiling in Large Databases , 2012, Discrimination and Privacy in the Information Society.

[28]  Koushik Maharatna,et al.  Systems Design for Remote Healthcare , 2013 .

[29]  Francis daCosta.  Rethinking the Internet of Things: A Scalable Approach to Connecting Everything , 2014 .

[30]  Sarah Sharples,et al.  Medical device design in context: A model of user-device interaction and consequences , 2012, Displays.

[31]  Alessandro Vasta,et al.  Multidisciplinary evaluation for severity of hazards applied to hemodialysis devices: an original risk analysis method. , 2010, Clinical journal of the American Society of Nephrology : CJASN.

[32]  Katarzyna Wac,et al.  Smartphone as a Personal, Pervasive Health Informatics Services Platform: Literature Review , 2012, Yearbook of Medical Informatics.

[33]  Leroy Hood,et al.  Systems Biology and P4 Medicine: Past, Present, and Future , 2013, Rambam Maimonides medical journal.

[34]  Jan Sliwa,et al.  A Web Architecture Based on Physical Data Separation Supporting Privacy Protection in Medical Research , 2012 .

[35]  R. Kramme,et al.  Medizintechnik — Verfahren, Systeme und Informationsverarbeitung , 1997 .

[36]  Luciano Floridi,et al.  The Philosophy of Information Quality , 2014, Synthese Library.

[37]  Bugra Gedik,et al.  Fundamentals of Stream Processing: Application Design, Systems, and Analytics , 2014 .

[38]  João Gama,et al.  Learning from Data Streams , 2009, Encyclopedia of Data Warehousing and Mining.

[39]  David Lyon,et al.  Surveillance, Snowden, and Big Data: Capacities, consequences, critique , 2014, Big Data Soc..

[40]  R. Lipton,et al.  Single-pulse transcranial magnetic stimulation for acute treatment of migraine with aura: a randomised, double-blind, parallel-group, sham-controlled trial , 2010, The Lancet Neurology.

[41]  T. Insel,et al.  Brain disorders? Precisely , 2015, Science.

[42]  N Teow,et al.  FDA Regulation of Medical Devices and Medical Device Reporting , 2013 .

[43]  Mukhtiar Memon,et al.  Carestore platform for seamless deployment of ambient assisted living applications and devices , 2013, 2013 7th International Conference on Pervasive Computing Technologies for Healthcare and Workshops.

[44]  Danica Marinac-Dabic,et al.  The international registry infrastructure for cardiovascular device evaluation and surveillance. , 2013, JAMA.

[45]  Brian A. Nosek,et al.  Scientific Utopia , 2012, Perspectives on psychological science : a journal of the Association for Psychological Science.

[46]  Sang C. Suh,et al.  Applied Cyber-Physical Systems , 2013, Springer New York.

[47]  Daniel Filippini,et al.  Autonomous Sensor Networks: Collective Sensing Strategies for Analytical Purposes , 2013 .

[48]  Jan Sliwa,et al.  Medical Evaluative Research and Privacy Protection , 2013, 2013 Sixth International Conference on Developments in eSystems Engineering.

[49]  Y. Shoenfeld,et al.  [The digital doctor]. , 2015, Harefuah.

[50]  J. Ioannidis.  Why Most Published Research Findings Are False , 2019, CHANCE.

[51]  Chiara Buratti,et al.  A Survey on Wireless Body Area Networks: Technologies and Design Challenges , 2014, IEEE Communications Surveys & Tutorials.

[52]  Karen M. Becker,et al.  Clinical Evaluation of Medical Devices: Principles and Case Studies , 2005 .

[53]  Ravishankar K. Iyer,et al.  Analysis of Safety-Critical Computer Failures in Medical Devices , 2013, IEEE Security & Privacy.

[54]  Jan Sliwa,et al.  Do We Need a Global Brain , 2012 .

[55]  Charu C. Aggarwal,et al.  Managing and Mining Sensor Data , 2013, Springer US.

[56]  Ana L. N. Fred,et al.  ECG Biometrics: Principles and Applications , 2013, BIOSIGNALS.

[57]  Helen Nissenbaum,et al.  Privacy in Context - Technology, Policy, and the Integrity of Social Life , 2009 .

[58]  Sharma Chakravarthy,et al.  Stream Data Processing: A Quality of Service Perspective - Modeling, Scheduling, Load Shedding, and Complex Event Processing , 2009, Advances in Database Systems.

[59]  Sarah Sharples,et al.  Medical device design for adolescent adherence and developmental goals: a case study of a cystic fibrosis physiotherapy device , 2014, Patient preference and adherence.

[60]  Mario Castro,et al.  Effectiveness and safety of bronchial thermoplasty in the treatment of severe asthma: a multicenter, randomized, double-blind, sham-controlled clinical trial. , 2010, American journal of respiratory and critical care medicine.

[61]  R. Hauser,et al.  Here we go again--another failure of postmarketing device surveillance. , 2012, The New England journal of medicine.

[62]  D. DeMets,et al.  Fundamentals of Clinical Trials , 1982 .

[63]  Diana M Eccles,et al.  The Angelina Jolie effect: how high celebrity profile can have a major impact on provision of cancer related services , 2014, Breast Cancer Research.

[64]  M. Drummond,et al.  Improving medical device regulation: the United States and Europe in perspective. , 2014, The Milbank quarterly.

[65]  Guosheng Yin,et al.  Clinical Trial Design: Bayesian and Frequentist Adaptive Methods , 2011 .

[66]  Roland Hetzer,et al.  Inhaled nitric oxide after left ventricular assist device implantation: a prospective, randomized, double-blind, multicenter, placebo-controlled trial. , 2011, The Journal of heart and lung transplantation : the official publication of the International Society for Heart Transplantation.

[67]  Daniele Sgandurra,et al.  A Survey on Security for Mobile Devices , 2013, IEEE Communications Surveys & Tutorials.

[68]  Balaji Raghunathan,et al.  The Complete Book of Data Anonymization: From Planning to Implementation , 2013 .