Given that María José has "picked up the gauntlet" :-), I will discuss the legal basis governing telemedicine services in Europe and Spain.
Thus, the document " Telemedicine for the Benefit of Patients, healthcare systems and Society," published in November 2008 and introduced the legal basis governing the deployment and use of telemedicine services in Europe, and it is recommended that by the end of 2011 , states should have adapted their legislation to cover such practices.
In fact, according to the summary document Trend Map 2010 TicSalut (in Catalan), pages 24 to 26 and I'll do a translation into Castilian, as it collected at these pages are in accordance with purpose of the post, the European legislation varies from country to country.
One of the major problems has been to integration processes within the workflow care telemedicine is the lack of regulation of this practice, mainly due to the legal vacuum on issues like the validity of a diagnosis made in a teleconsultation, certification of equipment, sensors, systems and other related information such as the provision of such disservice and especially reimbursement: who pays for these services, based on what measure and how to pay?.
Although from the European Union have issued a series of directives, such as the 95/46EC , apply in the case of patients' rights in cross-border health The 90/385EC implantable medical devices, and 93/42EC Discussion general practitioners, the reality is that among the EU member countries there has been no legislative developments to accompany the development of these services.
Thus, countries like Germany have no specific regulations but have a set of regulations in one way or another governing the sector. In fact, in this country we find that:
- Article 291st of SGB V (German regulatory framework of Social Security) provides that the reference infrastructure for eHealth is gematik, health insurance card.
- Article 67 of SGB V sets the log transformation role in electronic record. Article 291st
- 7-7 º in Book V provides for the refund
- The data protection laws of each Länder (similar but not identical) have direct application in telemedical services.
- The tele among professionals (consulting) are governed by the law of the medical profession.
- One obstacle is the professional code of conduct, which specifies that NO can be diagnosed if no examination of the patient made a face, which means that services can be deployed tele telemonitoring or treatment, but not teleconsultation.
- expressly authorizes the patient who has access and who is not in your medical record.
For instance, in California since 1996, through Telemedicine Development Act of 1996 , have a regulation which specifies such things as:
- The consults with clinicians in other states, and the definition of who is ultimately responsible for the process.
- The prohibition of on-line requirements.
- The existence of a contract between professional and patient.
- Telemedicine services are considered a health benefit more, subject to the same regulations as other conventional healthcare services.
What introduce this legislation?
- The definitions of the services that are part of the group telemedicine.
- certification of health professionals operating this systems
- unambiguous identification end-to-end patient -
- The certification of the components (hardware and software) the class that is involved in the process of providing a telemedicine service.
- The reimbursement: who pays, how metrics, who pays
- specific dates are subject to the health administration
- Training, if required, the patient in the use of devices partners.
- legal coverage of all involved in providing telemedicine services .
- specifically spoken of psychologists in providing this services.
In Spain, the legislation passed by the General Law of Health 14/1986, the Law 41/2002 Patient Autonomy , and, in a broad application, the Law 11/2007 on Electronic Access of Citizens to Public Services , without forgetting the Organic Law 15/1999 of Data Protection , and Royal Decree 1720 / 2007 developed by the Data Protection Act.
From the formal point of view, there is no specific development of telemedicine and telecare services, and significant barriers in the case of remote diagnosis, which simply and from a legal point of view can not be implement because current legislation states that the physician must be present at the bedside at the time of diagnosis.
On the other hand, in healthcare settings such as Catalan, mostly agreed, it is necessary to clearly define the concept reimbursement between all actors involved: the capitation where the patient resides and effecting center delivery.
Therefore, and for the issue at hand, we are talking about telecribaje ... sent an image, the dermatologist makes a presumptive diagnosis and clinical trial is to the patient call to his office to issue a definitive diagnosis.
I must say that a i2Cat development team is already working on the definition of an image capture app compatible with the practice of teledermatology using store and forward transmission of clinically relevant information (image / video / audio / text) to a secured environment for electronic medical record (accessible via web services and digital signature), using protocols for exchanging clinical documents and HL7 CDA as José María specifications.
is important to also explain that different methods are commonly used evaluation of telemedicine services, being commonly applied in Catalonia (over 200 deployments of telemedicine and telecare in the area) the methodology MAST (Model for Assessment of Telemedicine) .
Now it's up to you, Maria José. :-)
