title: Legal and organizational aspects of remote cardiac monitoring: the example of implantable cardioverter defibrillators.
abstract: The remote monitoring of implantable cardioverter defibrillators (ICDs) recently emerged as an attractive technological innovation that proved to be reasonably safe in partially replacing the in-clinic follow-ups of ICD patients with no or only mild symptoms. Apart from the fact that strong evidence about any additional clinical benefits and/or cost-efficiency are still awaited, legal and organizational hurdles remain in place, hampering any possibility for adoption of remote cardiac monitoring. This paper identifies a number of legal and organizational constraints which urgently need to be addressed. An elaboration of the specific juridical guidance for the interpretation and application of the relevant legislation is called for.
authors.affiliation: Belgian Healthcare Knowledge Centre (KCE), Kruidtuinlaan 55, B-1000 Brussel, Belgium. imgard.vinck@kce.fgov.be
authors.forename: Imgard
authors.initials: I
authors.lastname: Vinck
authors.forename: Chris
authors.initials: C
authors.lastname: De Laet
authors.forename: Serge
authors.initials: S
authors.lastname: Stroobandt
authors.forename: Hans
authors.initials: H
authors.lastname: Van Brabandt
mesh_terms: D001530:Belgium; D003219:Confidentiality / Q000331:legislation & jurisprudence; D017147:Defibrillators, Implantable; D003695:Delivery of Health Care / Q000331:legislation & jurisprudence* / Q000379:methods / Q000458:organization & administration*; D015716:Electrocardiography, Ambulatory / Q000191:economics / Q000295:instrumentation / Q000379:methods; D006801:Humans; D007258:Informed Consent / Q000331:legislation & jurisprudence; D008991:Monitoring, Physiologic / Q000191:economics / Q000295:instrumentation / Q000379:methods*; D058998:Remote Sensing Technology / Q000379:methods*