--- 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.