dimanche 1 décembre 2013

Connected Devices: their contribution to medical care “must be assessed on a case-by-case basis"

A lire sur: http://www.atelier.net/en/trends/articles/connected-devices-their-contribution-medical-care-must-be-assessed-case-case-basis_425679

By  November 26, 2013 
santé connectée

The steady penetration of connected objects into the health sector should only occur through a long process of regulation.
Interview with Dr Nicolas Postel-Vinay, a practitioner in the Hypertension unit at theGeorges-Pompidou European hospitaland Director of the self-measurement healthcare siteautomesure.com.
L’Atelier: Connected devices are mainly used these days in the area of the Quantified Self. How can they be put to real medical use, integrated into the healthcare ecosystem?
Nicolas Postel-Vinay: First of all, we need to understand what these connected objects actually are. If we’re talking about mass market devices that don’t have to comply with medical regulation and have been ‘connected’ for several years, everything still remains to be done in terms of assessment by the medical profession. You have to know exactly what potential contribution a device can make towards prevention, analysis and treatment and in this case all the trials and studies still need to be carried out. On the other hand, we do have quite a lot of experience with what is known as ‘telemedicine’, i.e.  connecting what are very often the same type of devices, but within a medical system, not a mass-market approach. In this case, we’ve already built up a sound body of knowledge. In the same vein, we’re also aware of the potential usefulness of these devices in the medical domain before they became connected. You cannot speak about connected objects and medicine as a single topic. The subject is broader than that. It covers a number of very different things. So we now really need to assess the contribution of these devices on a case-by-case basis rather than in overall terms.
Whose job will it be to take charge of the data? Will it be a task for intermediaries such as data managers?
Well, now we’re back to the question of how the data is going to be used. For example, if we’re talking about the weight of people suffering from heart or renal failure, or pregnant women, this information may be very useful, so it’s in the interests of doctors to obtain and analyse the data directly from the patient. On the other hand, if this is just about how much Mr and Mrs So-and-so weigh, there’s almost no medical value at all. The real value of medical data is only for specific cases.
Do you think that in order to incorporate connected objects into their work, doctors and other medical providers will have to change their business model?
Absolutely, but that will come from several different directions. First of all, in 2010 France adopted a legal definition of what telemedicine is. Since then, the potential is there to regulate the way a clinician makes his/her analysis on the basis of data from a patient, a connected device and the results received. Since there’s now a legal basis, attempts are being made to regulate the process. No firm decision has yet been taken, and in any case extremely strict conditions will have to be set as regards data anonymity, consent, acknowledgement of the reception of readings etc. And the mass-market connected devices won’t necessarily meet all the regulations. Meanwhile, the United States Food and Drug Administration is looking at the question of regulating connected devices. If they go through with it, the business model will change entirely because designers and manufacturers will then have to comply with far more demanding processes, which will make things slower and more costly, and this will radically transform the business model.
In your opinion, are these connected devices for everyone, or will they just be for an ‘elite’ who can afford them?
We’ve had some very good experiences with this type of equipment for measuring blood pressure, before the devices became ‘connected’. It will take time to reach the point of agreement between doctors, patients and regulation – the time to carry out scientific research, to obtain approval for the devices, and to secure acceptance from doctors once the scientific studies demonstrate positive results. In the case of blood pressure measuring devices it took close to twenty years. Perhaps things will speed up a bit now but anyway, as regards blood pressure, there’s now no difference in the self-measurement tools being used by the rich and the less well-off, at least not for the most part.

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