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Spectrum needs for wireless eHealth innovations – join the debate!

--- Posted by Daniel Kitscha (DG INFSO, Radio Spectrum Policy, Digital Agenda Assembly - Coordinator Workshop 17) on behalf of the author: Eric Klasen (Vice President, Regulatory Affairs and Quality, Medtronic International Trading Sàrl).

To launch the debate on "Spectrum for wireless innovation in Europe" (Digital Agenda Assembly Workshop 17 - #daa11spectrum) Eric Klasen (Vice President, Regulatory Affairs and Quality, Medtronic International Trading Sàrl) has provided us with his recommendations on spectrum needs for wireless eHealth innovations. Please join the discussion and provide your input by commenting on this blog post until June 10!

 SPECTRUM RECOMMENDATIONS FOR WIRELESS eHEALTH INNOVATIONS:

 1. Going forward, medical therapeutic and diagnostic applications will require, at a minimum, additional spectrum on a shared basis relative to a primary service. This type of regulatory structure will protect critical wireless medical applications from interference produced by Short Range Devices, digital systems and other sources of interfering radio emissions because it provides a legal basis for spectrum authorities to take any necessary action to address the interference issue.2. The degree of legal certainty in allocation and usage is principally governed by the allocation status of the band in which the equipment is permitted to operate and the attendant usage permitted in the band. Long-term legal certainty has to be addressed by providing specifically designated spectrum for the medical systems coupled with spectrum authorities’ recognition of the need to maintain stable spectrum regulations and provide long-term protection for usage of the band. A current example is Ultra Low Power Active Medical Implant (ULP-AMI) communication systems operating in the band 401 MHz to 406 MHz. This band was designated for use by ULP-AMI about ten years ago. It took several years to develop the radio technology that permitted device implantation within the human body due to size restraints and battery longevity. Today over 300.000 wireless-enabled Active Implantable Medical Devices (AIMD) have been implanted and this number has been rapidly expanding over the past five years. The lifetime of these devices can exceed 10 years. The ability of AIMDs to transfer critical data could easily be jeopardized by permitting other types of devices in the band.

 3. Sharing of the MEDAIDS band with ULP-AMI has been successful because these systems are based on the analysis performed by the ITU-R in the late 1990’s and published as ITU-R REC RS.1346. This analysis established the foundation for ULP-AMI sharing the band with the primary service provided it employed the parameters and advanced mitigation techniques specified in the recommendation. It also concluded that ULP-AMI could be designated as operating in the METAIDS band as a Mobile Service giving it protected status. This designation within Region 1 would provide ULP-AMI with interference protection from all sources of radio emissions other than the primary user. It also provides the authorities with a legal basis for addressing and resolving any interference which does occur. Such a designation does not preclude sharing, but it does require that systems (other than the primary user) show their operation is compatible with ULP-AMI systems.

4. The recommended proposal to protect wireless medical applications from harmful interference is to recognize that some critical medical applications such as Ultra Low Power Active Medical Implant (ULP-AMI) communication systems need to be recognized as a mobile service with secondary status on a shared, non-interference, and non-protected basis relative to the primary radio service. This type of status provides ULP-AMI a protection from SRD equipment, digital systems and ISM devices.

 5. Initially, the spectrum needs and benefits for wireless health applications can only be addressed through a dialog between the relevant medical trade associations and the regulators on an ongoing basis. Perhaps within the EC and ECC a committee could be established which would be a focal point where the Medical Industry could periodically discuss existing issues and future spectrum needs. Such a committee would inform the authorities of medical device advancements and future spectrum requirements.

6. The recommended necessary steps to foster wireless innovation in the healthcare sector:

(1)               Recognize the existing medical bands and their usage requirements, and adopt decisions that are aligned with technical parameters specified in existing ETSI standards.

(2)               Review existing spectrum specifically designated in Europe for the healthcare sector and discuss any current difficulties/issues with medical sector representatives.

(3)               Consider developing a proposal that would provide a generic band for use by any type of medical device (e.g. in-hospital or in-home patient wireless monitoring).

(4)               Develop specific EC Decisions on spectrum regulations for wireless medical applications (e.g. EC Decisions on RLAN, ULP-AMI, ITS and hearing aids) to provide legal certainty and spectrum regulations stability.

Comments

Peter Chadwick's picture

Additionally, the effects of PLT intermodulation and harmonics in interfering with home monitoring need careful consideration. Theoretically at least, it is possible that home PLT or otehr equipment meeting the EMC requirements of EN55022  (and PLT equipment meeting that standard does not have enough power to work properly!) will prevent the home use (and possibly clinic use) of ULP-AMI. This is not yet a problem: by the time it is recognised as one, it will be too late to do anything about it
kitscda's picture

@Peter: Would you have a recommedation how the careful consideration of this issue should be ensured?
Peter Chadwick's picture

CENELEC/CISPR/ETSI could be mandated by the Commission that any EMC standard for  PLT must effectively minimise radiation of radiated and conducted fundamental, harmonics and intermodulation products in the range 400 to 406 MHz to 20 dB below EN55022 limits. Only the Commission have the necessary powers to provide this protection, which is necessary for home monitoring to be succesful in the longer term.

  Spectrum Recommendations for Medical Body Area Network Systems 1. MBAN systems provide wireless networking of multiple body sensors and actuators used for monitoring patient physiological parameters, patient diagnosis and patient treatment, primarily in healthcare facilities as well as in other healthcare monitoring situations such as ambulances and the patient’s home. Use of MBANS holds the promise of improved quality and efficiency of patient care by reducing or eliminating a wide array of hardwired, patient-attached cables used by present monitoring technologies. There is a need for a cost effective and convenient way to be able to monitor every patient in a healthcare institution in order to provide earlier, and more accurate diagnosis, allowing clinicians to intervene and save lives. Operation of MBANS equipment is restricted to duly authorized healthcare professionals. 2. MBANS will be a key solution to open up patient monitoring for a larger class of patients and thereby will contribute to less occurrences of non-acute patients deteriorating, or not healing, during their hospital stay. This will reduce cost and improve patient outcomes. MBANS can reduce cable clutter, simplifying the care environment and making the patient more comfortable and the clinician happier. MBANS can eliminate/reduce the cross contamination hazard of reusable sensors and cables and can reduce hospital acquired infections.  Disposable sensors could help decrease hospital acquired infections helping save the €2K to €12K per patient. A dedicated band for MBANS will substantially help realise the three above, and will in addition reduce organizational costs for compensation measures to cater for the possibility of wireless communication dropouts. 3. Various MBANS use models are foreseen: · Universal Patient arrives at the hospital and is assigned to a MBANS device. As the patient moves through the hospital additional sensors are added or removed as patients condition requires. As the patient improves, the system scales back and at discharge the patient even can go home with sensors. · Home care Sensors can measure oxygen saturation, heart rate, motion, fall prevention and detection. · Neonatal Designed to support earlier discharge of premature babies to home. Offers an opportunity for lowering costs and improved family dynamics · Emergency department holding/waiting Every patient gets sensors for basic measurements to provide a basic level of monitoring while in waiting areas. · General ward Every patient gets sensors to assess basic condition. Tied to early warning and predictive monitoring, early intervention decreases preventable deaths. 4. Main requirements for MBANS spectrum are the availability of sufficient bandwidth in a dedicated frequency band, allowing low cost / low power equipment and offering opportunities for further innovation. The healthcare industry regards the 2.4 GHz band unsuitable for MBANS. Generic bands, like 2.4 GHz, will not support the growth of lower Tx-power (e.g. 1 mW) MBANS devices due to the increasing intense utilization of that band in healthcare facilities. In the US additional applications in hospitals that use this 2.4 GHz band are not allowed by hospital IT management, such a situation is also expected to appear in Europe. The healthcare industry is seeking dedicated MBANS spectrum immediately adjacent to the 2.4 GHz band to enable re-use of existing technology solutions. Amazing innovation opportunities exist by leveraging the existing low cost / low power radios such as IEEE 802.15.4 / ZigBee radios. The healthcare industry aims to create a global market, by harmonizing spectrum regulations in major markets (US, Europe) that can greatly facilitate innovation and drive down cost. 5. Recommended steps a. Progress the development of MBANS spectrum regulation in ECC based on the technical report created by ETSI (TR 101 557 - Medical Body Area Network Systems (MBANSs) operating in the band 2360 MHz to 2400 MHz). b. Set up the dialog between the relevant healthcare trade associations, the regulators and the EC on the innovation in wireless healthcare applications and the required allocation of frequency spectrum. c. Develop specific EC Decisions on spectrum regulations for wireless medical applications including MBANS to provide legal certainty and spectrum regulations stability. Ruud van Bokhorst Philips Healthcare ruud.van.bokhorst@philips.com  
kitscda's picture

The results of the Digital Agenda Assembly Workshop on “Spectrum for wireless innovation in Europe” (Workshop 17 – #daa11spectrum) are now online:   http://ec.europa.eu/information_society/events/cf/daa11/document.cfm?doc_id=18161   You can also find all presentations on the workshop website:   http://ec.europa.eu/information_society/events/cf/daa11/item-display.cfm?id=5998
wlan kamera's picture

yes radiation is some interesting topic i myself have some wlan cameras here to monitor stuff. but on the topic of radiation i havent heard some clear statement from experts yet. i myself think that mobile phones do much more radioation and so are more of an health issue.