Here are the main legal topics on telemedicine and eHealth discussed during the ETSI eHealth Workshop on telemedicine where I gave a speech on the legal implications of telemedicine.
The Workshop was very interesting with a number of presentations on telemedicine projects (whose slides are available here) that are expected to be implemented shortly or have already been partially implemented. The value of the eHealth market is expected to be € 60 billion and the value of the telemedicine sector is expected to reach $ 27.3 billion by 2016. This is my “very” personal top 5 list of main legal topics for telemedicine and eHealth:
1. Licensing and reimbursement
Telemedicine is an information society service for the purposes of the EU eCommerce Directive which prescribes for (i) the so called “country of origin” principle i.e. a telemedicine service provider shall only comply with the laws of its country of establishment and (ii) prohibits Member States of countries that are different from the providers’ country of origin from requiring these providers to obtain a prior local authorization to the offering of such services in their jurisdiction.
In relation to reimbursement of telemedicine services, the EU Directive 2011/24/EU provides the legal framework allowing patients to have their telemedicine services reimbursed even if provided in a country different from their country of residence provided that, they fall within the scope of reimbursed services in their country of residence and provided that (in some circumstances) they obtained a prior authorization from their country of residence.
Reimbursement of telemedicine services has been amongst the topics covered in the recent Italian guidelines on telemedicine that set out inter alia the criteria and authorizations required to obtain reimbursement of services in Italy. Such guidelines, and in general European laws, raise issues on whether telemedicine providers are required to obtain an additional local license/authorization if they want to “target” a jurisdiction rather than just assisting their patients when they move to a different EU Member State. Likewise, the issue relating to the types of telemedicine services that are not listed among the reimbursed services just because they are an innovation made possible as a consequence of the development of telemedicine services is left open.
2. Data protection
We have already covered the data protection issues relating to eHealth in this post. In addition to such issues, the security measures required by data protection laws (that in the case of Italy are extremely stringent) in order to protect personal data (for instance those stored in a cloud database) represent a major issue whose breach can trigger relevant fines especially in the light of the upcoming EU Privacy Regulation.
3. Product liability
European regulations on product liability are very stringent and set out a regime of strict/objective liability i.e. in case of malfunctioning patients shall prove only the defect to support their claim for damages and the burden of proof shall be on manufactures to prove that the damages were not caused by the alleged defect. The matter is even more complex in the case of telemedicine services since an erroneous treatment might for instance be due to a delay in the communication of data by the telecom carrier and therefore data provided to doctors might not be fully reliable. This would increase the risk exposure for both doctors that shall rely on inaccurate data and manufacturers of telemedicine services whose liability might be linked to circumstances out of their control.
4. Medical devices
The qualification of a telemedicine apparatus is always a difficult task and as covered in this post it should be assessed whether both software and hardware components are qualified as medical devices. The consequence of such qualification is that for instance, in case of any update or upgrade of software, a new approval process of the software as a medical device will be required which will inevitably delay the development of such technologies. Finally it should be assessed whether also “amusement” devices which can provide information about medical conditions of their users have to be qualified as medical devices impacting on the topics covered in this post.
5. Information to patients
Since telemedicine services often rely on data generated by devices used by patients themselves, in order to make such data reliable and useful for the provision of treatments, the information and instructions provided to patients are crucial. And indeed this is one of the main topics covered by the Italian guidelines on telemedicine.
The Italian guidelines on telemedicine also prescribe instructions on the requirements to be met in terms of service levels between telemedicine providers and hospitals as well as on ethical principles to be complied with.
This is a topic that will become more and more relevant in the coming months/years.