WEARABLE BIOMEDICAL SENSORS IN A TELE-HOME-CARE CONTEXT A FORESIGHT SCENARIO (with a focus on the patient´s use of tele

1. WEARABLE BIOMEDICAL SENSORS IN A TELE-HOME-CARE CONTEXTA FORESIGHT SCENARIO(with a focus on the patient´s use of tele-medical solitions) Fensli R.1, Hansen F.Ø.1, Gunnarson E.2, Gundersen T.3 1 Agder University College, Faculty of Technology and Science, Grimstad, Norway 2 Ullevaal University Hospital, Department of Anaesthesiology, Oslo, Norway 3 Sørlandet Sykehus HF, Medical department, Arendal, Norway Tromsø Telemedicine and eHealth Conference 2006, 12-14 June 2006

2. Outline • Trends and challenges in health care • Empowerment and self-care • Sensor technology and new possibilities • Tele-home-care • Body Area Network and reliability • Secure access to the patients “core EHR1” • Scenario: Wearable wireless monitoring • Research challenges 1 Electronic Health Record

3. Trends and challenges in health care A European trend: • Treat and follow up patients in their own home (out-of-hospital treatment) • (or on the elderly home/nursing-home) • Medical assistance can partly be achieved up to a defined level • by the use of new bio-medical sensors and wireless communication The reason for this is partly because of: • Aging of the population • Need of alternative and cheaper medical supervision and assistance • The request for integrated information and co-ordinated medical care • The patients are participating in their own treatment and training programme: Empowerment and Self-care “Hospitalization in your own home – hospital@home”

4. Sensor technology and new possibilities I • Vital signs monitoring will be performed by small wearable biomedical sensors • Almost all existing medical monitoring parameters • The patient has to operate non-invasive sensors • Use when needed for diagnosis and security reasons • Wireless transfer of information to medical services • Sensors can monitor, analyze + control therapy • Invasive sensors can monitor important parameters • Blood glucose, hormones, drug concentration etc…. • Give automatic control to drug administration (from deposits) Rubel P, Fayn J, L S-C, Atoui H, Ohlsson MT, D, Adami S, et al. New paradigms in telemedicine: ambient intelligence, wearable, pervasive and personalized. Stud Health Technol Inform 2004;108:123-32. Jovanov E, Raskovic D, Price J, Chapman J, Moore A, Krishnamurthy A. Patient Monitoring Using Personal Area Networks of Wireless Intelligent Sensors. Biomed Sci Instrum 2001;37:373-8.

5. Sensor technology and new possibilities II • Intelligent nano-sensors: • Can replace disabled functions • Heading aid, artificial eye, artificial voice, contact elements replacing sense impression etc. • Control muscle contractions and limb movements • “Read your thoughts and give desired actions” • Lab-on-chip (bio-sensor): • New possibilities for self-analysing blood samples • Future invasive analyzing and transferring capability Foresight projects: “Avanserte materialer Norge 2020”, The Norwegian Research Council “Foresight Biomedical Sensors”, a research project: www.nordic-fobis.net

6. Is really the patient capable ofcontrolling the new brilliant technology ? • It is a danger of letting techno-oriented persons designing health-care services: • “Are there any patients where we can put in this new revolutionary technology????” • The ultimate way of doing it: • “It all started with a crazy idea – but it was about solving a life-threatening medical problem” • The Norwegian company WPR Medical1 is funded on this philosophy when their wireless ECG-sensors was developed Elderly people can handle advanced sensor equipments – if they find benefits in using the solution (Fensli et. al, 2003)

7. Base station for Mobile telephone INTERNET WPR Internet connected server Wireless transfer of encountered ECG-alarm situations GPRS/ GSM Remote WPR Client at the hospital The Hand-Held device receives ECG-signals and uses automatic arrhythmia detection algorithms The patient can use a web-based system to contact the doctor and read the encountered ECG-findings The Doctor at the Hospital can make diagnostic evaluations of the recorded ECG-signals The patient is wearing the WPR wireless ECG-sensor Wearable wireless monitoring Fensli R, Gunnarson E, Gundersen T. A Wearable ECG-recording System for Continuous Arrhythmia Monitoring in a Wireless Tele-Home-Care Situation. In: The 18th IEEE International Symposium on Computer-Based Medical Systems; 2005 June 23-24, 2005; Dublin, Ireland; 2005. p. 407-12.

8. Tele-home-care • The patient can be treated in his own home • Wearable sensors will record vital signs parameters • Continuous detection with trend analysis • Automatic detection of un-normal situations • Automatic alarm in case of emergency • The health-care services can easily follow-up • Supervising the individual care-plan • Observing the medical condition • Watching changes and effects of medication • Exchange of information with questions and answers • Co-ordinated information between health care professionals and with the patient

9. BAN: Body Area Network Wireless sensors Hand-Held-Device (receiver unit) Body Area Network - BAN • Several international projects are focusing on BAN-technology with a plurality of sensors • However, no standard exists and proprietary solutions are developed with no interoperability Several possible radio-frequencies/systems Different communication protocols No international standards for wireless vital signs data-formats Problems with a plurality of patients without interfering each other No interoperability between different products/manufacturers WPAN, IEEE 802.15.4 is under development, but is not suitable for medical purposes

10. Reliability in wireless transfer • Wireless sensors needs event detection algorithms. • It is difficult to distinguish between errors in the wireless transmission from the different sensors used, and pathological situations detected. This can led to erroneous alarm conditions, and necessary precautions should be implemented in order to reduce the number of incorrect alarms. • Packet loss in the wireless transfer will most likely occur, and the delay of the transmitted signal can be unacceptable. • Golmie et. al(2005) showed that packet loss in a WPAN was 100% and the critical ECG-monitoring information was inaccessible, with wireless interference from traffic in existing WLAN systems A time series of ECG recordings obtained from a “Holter Monitor”, where the RR-intervals are erroneous calculated because of missing contacts at the electrodes. The recorded signal has packet losses (shown by the negative-going lines) due to an “out-of-range” situation with wireless transmission errors.

11. C-EHR • "core electronic health record" (C-EHR) is used to describe a “common data sets” as the minimum of information required to get an adequate overview of the patient's actual situation • This core journal can in fact be “owned” by the patient himself, and he will have to take control of the necessary authorizations of who is obliged to have access to the various parts of the information. • The patient can write his medical diary into the system and can keep tracking of medications, actual vital signs recordings, training results etc. • In cases of emergency, the need of quick medical assistance can be important and in life threatening situations there will be a need of quick access to the patients EHR in order to give the correct treatment. • Today, no one has a proper solution AHIMA: myPHR Personal Health Record, http://www.myphr.com

12. Scenario • In an emergency situation, it can be important for the rescuing personnel to have direct access to the patients EHR information and can in a future solution be implemented in a C-EHR to be shared between the patient and the health care services. • A physician at the rescuing station should then be given access to the central core journal, regulated by a Role Based Access Control mechanism Hansen, F.Ø., Fensli, R.: Method for Automatic Escalation of Access Rights to the Electronic Health Record. To be presented at MIE 2006.

13. Mobile patient-doctor communication • Development of new mobile phone services can also be used in medical treatment and diagnosis • Case: • Man, 56, at vacation in his sail-boat suddenly gets a heart attack • His wife finds his emergency suitcase with wireless ECG-sensors • She helps him putting on the wireless ECG-recording equipment • Automatically the real-time recordings are transferred to the doctor • He can discover un-regular heart beats with atrial fibrillation • By use of the mobile with a camera, the doctor can speak with the patient about his condition, but can also observe the lip colours • His quick investigation is immediate medication (from the suitcase) • The patient needs quick treatment at the nearest hospital • The doctor records his voice-epicrisis and helps with escalating the EHR-access for doctors at the nearest hospital

14. Privacy and confidentiality • In automatic wireless monitoring solutions, it is important to regulate the access to the EHR-information • The patient can give different access rights to different parts of information • The doctor don't need the patients location unless a critical situations • No need of transferring a waste of normal recordings • No need of instant actions unless an un-normal situation is detected • To protect privacy, security must be ensured • Information transfer within National Health Networks • Encryption solutions must be implemented in handheld wireless units • PKI systems and smart cards used for secure access to information • Administration of access control is done by using an SRBAC1 solution with location based services 1Spatial Role Based Access Control

15. The ECG-solution of WPR1 • This system has several possible uses: • Long time ECG-recordings with arrhythmia detection (Holter), Telemetry solutions and Monitoring purposes • Continuous event recording and alarm system • Primarily designed for use in a Tele-home-care situation • Patients outside the hospital can be under continuous monitoring in cases where the medical diagnostics and treatment needs a close follow-up by the doctors • This can be situations for: • Early observation or screening for possible arrhythmia incidents • Arrhythmia diagnostic of patients with rarely occurrences • Control of medication for patients with atrium fibrillation • Patient follow up after intervention and treatment 1 Wireless Patient Recording Medical AS, www.wprmedical.com

16. Research challenges • Development of new tele-medical services will face a lot of technical research challenges • Technical difficulties in sensor design, antenna construction, battery consumptions, miniaturization, wireless transfer etc. • A lack of suitable standards defining interoperability • Reliability in monitoring procedures and automatic event detection • User interface and easily understandable solutions • Main obstacles can be getting new procedures accepted • A lack of tele-medical standards defining procedures and intervention • New ways of co-ordinated medical care and support • Research projects need to focus on patient outcome • What are the benefits from the patients point of view ?

17. Publications • Fensli R, Gunnarson E, Gundersen T. A Wearable ECG-recording System for Continuous Arrhythmia Monitoring in a Wireless Tele-Home-Care Situation. In: The 18th IEEE International Symposium on Computer-Based Medical Systems; 2005 June 23-24, 2005; Dublin, Ireland; 2005. p. 407-12. • Fensli R, Gunnarson E, Hejlesen O. “A Wireless Cardiac Alarm System for Continuous Event Recording”. Medinfo2004; September 7-11, 2004; San Francisco; USA; pp 1598. • Fensli R, Gunnarson E, Hejlesen O. “A Wireless ECG System for Continuous Event Recording and Communication to a Clinical Alarm Station”. 26th Annual International Conference IEEE Engineering in Medicine and Biology Society; September 1-5, 2004; San Francisco; USA; pp 2208-11. • Fensli R, Gundersen T, Gunnarson E. “Design Requirements for Long-Time ECG recordings in a Tele-Home-Care Situation, A Survey Study”. Scandinavian Conference in Health Informatics 2004 ; August 23 -25, 2003; Arendal, Norway. pp. 14-18. • Fensli R, Gunnarson E. “Mobile Monitoring of Vital Parameters within the Electronic Health record - Medical, Technological and Legal aspects”. Tromsø Telemedicine and eHealth Conference - TTeC2004; 21.-23. June 2004; Tromsø, Norway; pp 46. • Fensli R, Thorstensen H. “Security aspects of Wireless Medical Computer Networks. A proposal of combined security measures”. Scandinavian Conference in Health Informatics 2003 ; June 13 -14, 2003; Arendal, Norway. pp. 21-29.