Evidence-Based Development Approach for Safe, Sustainable and Secure Mobile Medical App

According to industry surveys, by 2018, more than 1.7 billion smartphone and tablet users will have downloaded at least one mobile medical app (MMA) [40]. Such widespread adoption of smartphone based medical apps is opening new avenues for innovation, bringing MMAs to the forefront of low cost healthcare delivery. These apps often control human physiology and work on sensitive health data, thus it is necessary to have evidences of their trustworthiness before actual marketing. The key challenges in ensuring trustworthiness of MMAs are maintaining privacy of health data, long term operation of wearable sensors and ensuring no physical harm to the user. Traditionally, clinical studies are used to generate evidences of trustworthiness of medical systems. However, they can take a long time and could potentially harm the user during studies. Thus it is essential to establish trustworthiness of MMAs before their actual use. One way to generate such evidences can be using simulations and mathematical analysis. These methods involve estimating the MMA interactions with human physiology. However, the nonlinear nature of human physiology makes the estimation challenging.

[1]  Vincent Rijmen,et al.  The Design of Rijndael , 2002, Information Security and Cryptography.

[2]  Edward A. Lee,et al.  Viptos: a graphical development and simulation environment for TinyOS-based wireless sensor networks , 2005, SenSys '05.

[3]  Mikael Pohjola,et al.  PiccSIM Toolchain - design, simulation and automatic implementation of wireless networked control systems , 2009, 2009 International Conference on Networking, Sensing and Control.

[4]  Daniel Kroening,et al.  A Survey of Automated Techniques for Formal Software Verification , 2008, IEEE Transactions on Computer-Aided Design of Integrated Circuits and Systems.

[5]  Zhihao Jiang,et al.  Cyber–Physical Modeling of Implantable Cardiac Medical Devices , 2012, Proceedings of the IEEE.

[6]  Oded Maler,et al.  Computing Reachable States for Nonlinear Biological Models , 2009, CMSB.

[7]  Chenyang Lu,et al.  Realistic case studies of wireless structural control , 2013, 2013 ACM/IEEE International Conference on Cyber-Physical Systems (ICCPS).

[8]  Ayan Banerjee,et al.  Optimal Design for Symbiotic Wearable Wireless Sensors , 2014, 2014 11th International Conference on Wearable and Implantable Body Sensor Networks.

[9]  Yi Zhang,et al.  Safety-assured development of the GPCA infusion pump software , 2011, 2011 Proceedings of the Ninth ACM International Conference on Embedded Software (EMSOFT).

[10]  Ayan Banerjee,et al.  BAND-AiDe: A Tool for Cyber-Physical Oriented Analysis and Design of Body Area Networks and Devices , 2012, TECS.

[11]  Ayan Banerjee,et al.  Spatio-temporal hybrid automata for safe cyber-physical systems: A medical case study , 2013, 2013 ACM/IEEE International Conference on Cyber-Physical Systems (ICCPS).

[12]  Cristian Ungureanu,et al.  Mobile Data Sync in a Blink , 2013, HotStorage.

[13]  A. Ron,et al.  Local approximation by certain spaces of exponential polynomials, approximation order of exponential box splines, and related interpolation problems , 1990 .

[14]  H M Byrne,et al.  A mathematical model to study the effects of drug resistance and vasculature on the response of solid tumors to chemotherapy. , 2000, Mathematical biosciences.

[15]  T Laakko,et al.  Mobile Health and Wellness Application Framework , 2008, Methods of Information in Medicine.

[16]  Mosa Ali Abu-Rgheff,et al.  3G wireless communications for mobile robotic tele-ultrasonography systems , 2006, IEEE Communications Magazine.

[17]  Ayan Banerjee,et al.  Evaluation of body sensor network platforms: a design space and benchmarking analysis , 2010, Wireless Health.

[18]  Sandeep K. S. Gupta,et al.  Body Area Networks: Safety, Security, and Sustainability , 2013 .

[19]  Ayan Banerjee,et al.  bHealthy: a physiological feedback-based mobile wellness application suite , 2013, Wireless Health.

[20]  Osamu Kobayashi,et al.  Mass production cost of PEM fuel cell by learning curve , 2004 .

[21]  Hung Keng Pung,et al.  A middleware for building context-aware mobile services , 2004, 2004 IEEE 59th Vehicular Technology Conference. VTC 2004-Spring (IEEE Cat. No.04CH37514).

[22]  Charles R. Farrar,et al.  Energy Harvesting for Structural Health Monitoring Sensor Networks , 2008 .

[23]  Patrick Cousot,et al.  Abstract interpretation: a unified lattice model for static analysis of programs by construction or approximation of fixpoints , 1977, POPL.

[24]  Xiaowei Li,et al.  Integrated simulation and emulation platform for cyber-physical system security experimentation , 2012, HiCoNS '12.

[25]  Jeffrey M. Voas,et al.  Trustworthiness in Software Environments , 2009, IT Professional.

[26]  Ayan Banerjee,et al.  Health-Dev: Model Based Development Pervasive Health Monitoring Systems , 2012, 2012 Ninth International Conference on Wearable and Implantable Body Sensor Networks.

[27]  Ayan Banerjee,et al.  Analysis of Smart Mobile Applications for Healthcare under Dynamic Context Changes , 2015, IEEE Transactions on Mobile Computing.

[28]  Amos Ron,et al.  Exponential box splines , 1988 .

[29]  Ayan Banerjee,et al.  PEES: physiology-based end-to-end security for mHealth , 2013, Wireless Health.

[30]  Antoine Girard,et al.  Hybridization methods for the analysis of nonlinear systems , 2007, Acta Informatica.

[31]  Karl H. Johansson,et al.  GISOO: A virtual testbed for wireless cyber-physical systems , 2013, IECON 2013 - 39th Annual Conference of the IEEE Industrial Electronics Society.

[32]  Matthias Althoff,et al.  Reachability analysis of nonlinear systems using conservative polynomialization and non-convex sets , 2013, HSCC '13.

[33]  Ramesh Jain,et al.  Situation based control for cyber-physical environments , 2009, MILCOM 2009 - 2009 IEEE Military Communications Conference.

[34]  Sandeep K. S. Gupta,et al.  Research challenges in wireless networks of biomedical sensors , 2001, MobiCom '01.

[35]  D. Ward,et al.  The hybrid model: a new pharmacokinetic model for computer-controlled infusion pumps , 1994, IEEE Transactions on Biomedical Engineering.

[36]  Yuan Xue,et al.  NCSWT: An integrated modeling and simulation tool for networked control systems , 2012, Simul. Model. Pract. Theory.

[37]  Ann Miller,et al.  Integrated Cyber-Physical Simulation of Intelligent Water Distribution Networks , 2011 .

[38]  Emil Jovanov,et al.  Guest Editorial Introduction to the Special Section on M-Health: Beyond Seamless Mobility and Global Wireless Health-Care Connectivity , 2004, IEEE Transactions on Information Technology in Biomedicine.

[39]  Edward Amoroso,et al.  A process-oriented methodology for assessing and improving software trustworthiness , 1994, CCS '94.

[40]  Yu-Te Liao,et al.  A 3-$\mu\hbox{W}$ CMOS Glucose Sensor for Wireless Contact-Lens Tear Glucose Monitoring , 2012, IEEE Journal of Solid-State Circuits.

[41]  H. H. Pennes Analysis of tissue and arterial blood temperatures in the resting human forearm. 1948. , 1948, Journal of applied physiology.

[42]  Ayan Banerjee,et al.  Hybrid simulator for cyber-physical energy systems , 2013, 2013 Workshop on Modeling and Simulation of Cyber-Physical Energy Systems (MSCPES).

[43]  M. Borrello Modeling and control of systems for critical care ventilation , 2005, Proceedings of the 2005, American Control Conference, 2005..

[44]  James Bret Michael,et al.  Verification and Validation for Trustworthy Software Systems , 2011, IEEE Software.

[45]  Ayan Banerjee,et al.  PSKA: Usable and Secure Key Agreement Scheme for Body Area Networks , 2010, IEEE Transactions on Information Technology in Biomedicine.

[46]  Qi Hao,et al.  Trustworthy Data Collection From Implantable Medical Devices Via High-Speed Security Implementation Based on IEEE 1363 , 2010, IEEE Transactions on Information Technology in Biomedicine.

[47]  Eric Eide,et al.  Efficient memory safety for TinyOS , 2007, SenSys '07.

[48]  Alex Doboli,et al.  A simulation framework for PSoC based Cyber Physical Systems , 2010, 2010 International Joint Conference on Computational Cybernetics and Technical Informatics.

[49]  Kenneth G. Paterson,et al.  Certificateless Public Key Cryptography , 2003 .

[50]  Mihail L. Sichitiu,et al.  RaPTEX: Rapid prototyping tool for embedded communication systems , 2010, TOSN.

[51]  Antoine Girard,et al.  Reachability Analysis of Nonlinear Systems Using Conservative Approximation , 2003, HSCC.

[52]  Hilding Elmqvist,et al.  Cyber-Physical Systems Modeling and Simulation with Modelica , 2011 .

[53]  Vincent Rijmen,et al.  The Design of Rijndael: AES - The Advanced Encryption Standard , 2002 .

[54]  George C. Necula,et al.  Dependent Types for Low-Level Programming , 2007, ESOP.

[55]  Witold Suryn,et al.  Software Trustworthiness: Past, Present and Future , 2012, ISCTCS.

[56]  M. Guerra‒Balcázar,et al.  Glycerol oxidation in a microfluidic fuel cell using Pd/C and Pd/MWCNT anodes electrodes , 2013 .

[57]  Thao Dang Approximate Reachability Computation for Polynomial Systems , 2006, HSCC.

[58]  C. Cobelli,et al.  Artificial Pancreas: Past, Present, Future , 2011, Diabetes.

[59]  Ayan Banerjee,et al.  GeM-REM: Generative Model-Driven Resource Efficient ECG Monitoring in Body Sensor Networks , 2011, 2011 International Conference on Body Sensor Networks.

[60]  Oded Maler,et al.  Accurate hybridization of nonlinear systems , 2010, HSCC '10.

[61]  Carlo Curino,et al.  Mobius: unified messaging and data serving for mobile apps , 2012, MobiSys '12.

[62]  D. Estrin,et al.  Open mHealth Architecture: An Engine for Health Care Innovation , 2010, Science.

[63]  K.-E. Arzen,et al.  How does control timing affect performance? Analysis and simulation of timing using Jitterbug and TrueTime , 2003, IEEE Control Systems.

[64]  Thomas A. Henzinger,et al.  Beyond HYTECH: Hybrid Systems Analysis Using Interval Numerical Methods , 2000, HSCC.

[65]  Ayan Banerjee,et al.  Challenges of implementing cyber-physical security solutions in body area networks , 2009, BODYNETS.