Overview of the Regulations and Factual Backgrounds of Remote Medical Consultation and Treatment in Germany, France, the UK, Spain and Italy

Date: May 19, 2020
Good afternoon and welcome. It’s a real pleasure to have you with us. A warm welcome also to my colleagues from our offices in London and Paris from Portoland Cavalld in Milan as well as GAP in Madrid. Before we start with our webinar, I would like to make you aware that there is the possibility to ask questions you during the webinar. Please use the Q&A tool to send us as many, any question you might have. We will answer as many questions as possible in the last 10 to 15 minutes of the webinar. You can send us the questions anonymously or add your name. If you add your name, we can answer questions also in writing if we should not be able to answer all questions today. We will start our tour, or your tour, through the regulations and factual backgrounds on removed medical consultation and treatment in Germany. Then we go to France and the UK, and Italy and Spain will follow. Let’s start. First slide please.

Until three years ago, there were only a few regulations on the telemedical treatment in Germany. Remote medical treatment did actually not exist in the everyday life. Only the last three years there were progress in the sector. Also thank you to the current minister of Alt Gensungen. He promoted the development of telemedical issues in Germany by amending the respective flaws on national level. He ruled the technical and safety requirements for telemedic infrastructure and equipment in the social security code 5. The telemedic infrastructure ensures high technical and data protection standards. It must be used by all physicians licensed to treat patients in the statutory health insurance systems. This around 90% of the German residents. Let’s start to introduce more and more reimbursement tariffs in the payments scheme of the statutory health insurance system for telemedical treatments. This step has been very important, as without reimbursement, there is no remuneration for physicians. And where there is no remuneration, there’s no telemedical services that are offered to patients. Most aspects off telemedical treatment, however, fall into the legislative competence of single German states or the self-governing professional associations. Therefore, only after the majority of the state associations of physician’s licensed in the statutory health caste system, amended, at the beginning off 2018, the professional code for physicians, and allowed exclusive consultation and treatment of patients via a distance communications medium. The telemedicine in sector in Germany is really developing. According to professional laws, remote medical treatment is only permitted in cases in which such treatment is medically adequate and required, where professional medical diligence is guaranteed. One of the latest… developments, which are still in the start of a work in progress, regard the legitimacy of the e-prescriptions. I’ll come back to this later in my talk. Pharmacies allowed, only since August of 2019, to disperse drugs to patients who are obviously being treated exclusively via a distance communications media. Another very recent innovation is the possibility of patients insured in the statutory health care system to receive digital health apps on prescription. Digital health apps are software and apps to detect monitor and treat diseases. The costs are reimbursed by the healthcare insurance funds if the app is registered and licensed by the German Federal Institute for Drugs and Medical Devices. Second slide, please.

Traditionally, medical treatment take place in direct and personal doctor patient contact, is to say was physical in simultaneous presence off the doctor and the patient in the same room at the same time, and this direct interaction between both. Telemedical treatment is the, approach from, covering all indirect doctor patient contexts by mean of distance communication, like telephone, video or digital applications. But also, with indirect contact with the third person of reference involved. Therefore, the technical monitoring off blood levels or other physical values is covered by telemedicine as well as telecounseling between doctors. As to the remuneration and reimbursement regulations on telemedical treatment, I would like to focus today on the remuneration of medical services rendered by phone or video conference and the net, not yet fully introduce possibility for patients to receive Digital Health apps on prescription. The most regulated and therefore most used medium of distance communication for telemedical treatment in Germany is the video conference. The use increased significantly during the current COVID 19 pandemic. The reason for this is not only that by the use of video conference, higher health protection for doctor and patient is guaranteed, but also the temporary possibility for physicians to use video conferences exclusively and unlimitedly to treat patients insured in the statutory health insurance. Doctors are fully remunerated until June of this year. Afterwards, very probably, the usual restrictions on the amount of video conferences that doctors can use per quarter and per patients, before the remuneration is discounted or even stopped, may be reintroduced. In my view, that’s a real pity. Telemedical treatment by phone is recognized in Germany as well. In particularly, it is used to care for nursing home residents, imperative patients with the involvement of third parties. In the regular practice of doctor’s offices, consultations by phone has no important rule. It is they are only reimbursed once a quarter and only restrained euros. The basic calculations on prescription and reimbursement of digital health apps became law only in December of the last year. In April of this year, BPharm enacted procedural rules for the registration process, offers virtual digital health apps. Their approval and registration of each app is mandatory. In all of that, doctors can prescribe the app and the costs are reimbursed. So far, there are no digital health apps that have been registered. Hopefully, that will change quickly. Also, the applicable pricing rules for apps are still discussed between the German Federal Association of Health Insurance Funds and the Association of App Manufacturers. Third slide, please.

Until today, e-prescriptions and are not yet used as rule in Germany. Currently, there are only several of pilot projects, around 50 in the different German states. The German minister of health is planning, however, that a first generation 2022, physicians must prescribe drugs on e-prescriptions and pharmacies must accept them to dispose the prescribed drug. At the moment, the competent public authorities and professional associations are working to implement the technical and legal requirements in order that e-prescription can be regularly used within the telematic infrastructure of the statutory health care system. As of 30 September of this year, all pharmacies must be connected to the telematic infrastructure. Physicians must already be connected since July 2019. The legislator entrusted the construction in maintenance of the telematic infrastructure to a special created company, the Association on Telematics so called Gematic. The Gematic is called up to develop and provide software and acts for patients to get digital access to e-prescription at the latest by June 2021. As a first generation 2022, the use of e-prescription is mandatory, unless the patient asked explicitly for paper prescription. From the same day and on, Pharmacies must accept and dispense drugs on e-prescriptions. E-prescriptions do not only make sense if patients are not obliged anymore to go in-person to the pharmacy to get their drug, but if they can also ask for home delivery. Already now, such home deliveries are possible and legal in Germany. Pharmacies with local stores in Germany may deliver the drug by courier or open an online pharmacy that has to be authorized to develop, deliver drugs by mail. Pharmacies with local stores in other EU or ESTA countries can deliver drugs by mail to German residents only if the security and safety standards in the whole country with regard to pharmaceuticals equivalent to the German standards. So far, only online pharmacies in Iceland and the United Kingdom can fully operate in Germany. Only pharmacies online promises in the Netherlands, Sweden and the Czech Republic can operate as well but with some restrictions. Last slide, please.

I’m concluding here and handing over to my colleague and friend from our Paris office. Thank you for your attention.

Sorry. As you can see from Carolyn’s presentation, the German framework is very efficient. Unfortunately, the French telemedicine rules have been more regulated. The five telemedicine acts actually prints. Sorry, you can, next slide please.

Yes, thank you. The five telemedicine acts are actually in French regulation. You have tele-expertise which is effects to remotely solicit and expert opinion between healthcare professionals. Secondly, you have the tele-monitoring, which is the effects to remotely interpret so that the necessary for the medical follow up occupations. Then, the tele-assistance, which is the remote assistance of a healthcare professional by another healthcare professional during the performance of a medical act. Then the regulation, which is the remote consultation by a healthcare professional within emergency medical services. And teleconsultation, online consultation, which is a medical act, and it must be conducted by your registered physician in compliance with the physicians…. Of course, there, thank you, constraints regarding online consultation. The patient must give his free and informed consent higher to the online consultation. Teleconsultation in France must be carried out by video transmission, as opposed to a phone call, and with adapted equipment for clinical situation of the patient to guarantee the performance of a quality consultation. In practice, patients are instructed to login with a secure up app via computer, tablet or smartphone, equipped with a webcam in front. Online consultations are usually carried out via dedicated apps such as …, okay. In addition, since an older date, the 2nd September 2019, online consultations can also be carried out in pharmacy. In practice, we can put in certain pharmacies a closed room in which are conducted online consultations. Pharmacies may contract with companies like … to ask that fully equipped online consultation have been in their premises. The physician performing the online consultation, must record medical information in the patient’s medical file. Next slide, please.

In addition to telemedical constraints, physicians must comply with privacy and security rules which are, each online consultation must be conducted through a secure device that ensures identification off both physician and patients. Physicians access to the patients as that as necessary for the medical consultations. And, of course, the confidentiality of the physicians and patients exchanges. Both patient and physician must become comfortable with using the telemedicine software and it is necessary to try and do so. The physician must store patients’ health data exclusively on severs operated by duly certified hosting providers. The physician must ensure that the software used to bear from online consultations comply with applicable interoperability and security standards … in order to guarantee the quality, confidentiality, and protection of personal health data. The requirement is exceptionally waived in the context of the senate that certainty recruits is by the decree dated 19th March 2020, care to COVID 19 patients may be performed by any digital tools such as Skype, FaceTime, or WhatsApp. Next slide, please.

In order to be reimbursed to basic French statutory health insurance, online consultations must be performed in accordance with the following conditions. Firstly, the online consultations must follow the mandatory care path, in French parcours de soin. The physician performing the online consultation must be the patient’s main physician. Or, and the physician must already know the patients. In other words, the patient must have had a face to face consultation with this physician in a 12-month period prior to the online consultation. By way of exception, online consultations do not have to follow the mandatory care path to be reimbursed if the patient is under 16 years old, the online consultation involves certain medical specialties that require direct access by the patient, such as gynecology, ophthalmology, or pediatrics, or the patient’s main physician is not available. In the context of sanitary situations, there are specific requirements with respect to the reimbursements. Online consultations requested by any affected or potentially affected COVID 19 patients will be reimbursed even if they are performed outside the mandatory care path. With a physician who does not know the patients, and a decree dated 21, 21st, sorry, April 2020 … the reimbursement of online consultations carry out by telephone for patients who do not have access to high speed Internet connection or who do not have a device… with transmission. For patients over 17 years old, patients we still use them in this are pregnant woman.

Next slide, please. Thank you. Telemedicine makes it possible, in particular, to prescribe products and prescribed services of procedures. Consequently, following an online consultation, the physician may issue a prescription, if necessary. E-prescription and paper prescriptions transmitted electronically differs from each other. E-prescriptions are not yet regulated in France and are still under experimentation. Electronic prescriptions are defined in a paper prescription issued by your physician with QR code to be scanned by the pharmacist. Whereas, currently, a physician may issue a paper prescription that are transmitted electronically, including after having performed an online consultation. The prescription can be transmitted to the patients by first, by electronic messaging system, provided that its messaging system complies with applicable interoperability ability and security standards prepared by the French Digital Health Agency in order to guarantee the quality, confidentiality, and the protection of personal health data. And then the patients will then printout prescription or mail it to the pharmacist of its choice. As you can see, the French framework, sorry, is clearly defined and the COVID 19 crisis illustrates this perfectly well. Thank you and Sharon, go ahead.

Thanks very much. And thank you for, looking toward speaking you today about remote medical consultation and treatment in the UK. I think an important part to recognize about the UK is that telemedicine and remote consultations are, are and were precoded as already an established part of healthcare delivery and started about 4 to 5 years ago and have been growing in significant popularity. Before I start, most of the audience may know that a key dimension of the UK market, like some of the other European markets, is that there is a National Health Service that operates across England, Wales and Scotland, and Northern Ireland. And estimates are that approximately 90% off healthcare is paid for by NHS commissioners, but importantly, that care is provided by both public, so NHS, and private providers and for primary care, all providers are private. So initially, telemedicine services took off in the UK in primary care. And the first, kind of, features of that were teleconsultation with a general practitioner. And whilst the first steps were made in the private GP markets are not NHS reimbursed, since 2016 there has been significant growth in NHS primary care. And the way this would ordinarily work is that NHS general practitioners would outsource or contract with private telemedicine platforms, and those telemedicine platforms may either provide that care themselves through their own contracted doctors, or, the NHS doctors may simply use the telemedicine platform to provide the care to them. Now, initially, there were some concerns about the reimbursement of primary care through the NHS. And, a key feature of primary care is that general practitioners and primary care services are largely paid on a per capita basis. So that’s to say that when patients register with a doctor, that patient, that doctor, receives a payment based on the number of registered patients on that list. And the initial concerns were threefold. First, there was an objection to the safety and how a doctor would discharge professional regulations. So, kind of, a safety question. The second issue related to reimbursement. And that was because patients who were most like likely to adopt and to use telemedicine solutions were typically tech savvy younger patients, who were wanting care on the move. Now, when care is calculated on a per capita basis, the overall payment the general practitioner is premised on an assumption that some patients will require more care than others. So, it’s, although you paid the same per list with some weighting adjustments, often it is older patients with abilities that require a greater significant of the budget for care. They may attend, more frequently, appointments, and require a greater level of care overall. And the concern was that if younger people were using telemedicine platforms and were choosing to move to telemedicine NHS practitioners, that would mean that, effectively, the money that was left to pay for non GP telemedicine practice would have to cater for older populations with a flock to younger patients on telemedicine-only platforms. So to accommodate this, and also because there has been a huge promotion of digital online healthcare, there have been some significant changes in policies over the last two or three years. The first of these was set out in a policy document, the NHS Long Term Plan was issued last year. And that promoted what was described as a simplified patient journey and is shown on the picture on the screen. And the commitment was given in the NHS Long Term Plan that every patient would have the right to a digital first primary care service. And this year, in 2020, the first contract was included, which actually included contractual commitments on every single NHS GP to ensure that at least 25% of appointments were available for online booking with a quality framework still to be developed. And by next year, April 2021, they were entitled to a video consultation. So you can see that even before COVID, we had a massive acceleration and moved towards telemedicine and remote medicine platforms. Now, to accommodate that along the move, the regulation has tightly had to catch up with the move to digital performance and there being a number of regulatory developments. The first is that all health care providers are required to be registered with the Care Quality Commission. And specific guidance was issued in 2017 to accommodate online and remote care with specific criteria to be met by online health providers. And the second element was the professional rules were updated so that doctors were clear when it was appropriate in their professional judgment to see patients on a remote basis and when it was appropriate for them to be seen in person. So, in fact, the regulatory system is already pretty well developed in respect of telemedicine and accommodation of payment due to the capitation, the capitated basis of payment. Now, of course, in the beginning of March 2020, was the impact of COVID that saw a massive increase. And at that time, GPs were told by the Department of Health and Social Care to largely switch to digital consultations and it’s necessary to combat COVID 19. And unless, in exceptional circumstances, particularly because patients are reluctant to attend healthcare facilities, it is estimated that most primary care over the COVID period has been delivered through a telemedicine or remote platform. Next slide, please.

Now we have to contrast the payment arrangements for primary care, which is the first appointment with a general practitioner and hospital-based care, so secondary care where there has not been that speed of adoption. So it’s typically consultants, so this is doctors in a hospital setting, were not using remote telemedicine in the same way that was being used across the primary care, kind of, sector. But last year, 2019/2020 in our National Tariff Payment System which sets out prices for NHS services, the first moves were made to allow for reimbursement for telemedicine. Now, this wasn’t a dictated tariff, if it was what have described in our National Tariff Payment System as a non-mandatory price, so a price that can be negotiated and is a recommended tariff. All telemedicine or non-face-to-face activity, so remote care, would, would largely be up for negotiation and discussion between a commissioner and a provider, but with an assumption that that would initially be remunerated on the same basis as an in-patient outpatient, an in person, outpatient appointment. And the National Tariff System also said that there were incentives and encouragement to move to new digital models. Now again in the setting of hospital outpatients for the secondary care, the impact of COVID 19 has seen a huge escalation and hospital doctors secondary care provision was encouraged very strongly to move to virtual consultations. And the estimated move, over the last two months, has been estimated at what was in outpatient care, hospital outpatient care 200 consultations a day to more than 6000 virtual consultations per day. Now partly, this is because hospitals were provided with access to a recommended platform that was endorsed by the Department of Health and Care, Social Care, but they were also encouraged to use other platforms and permitted to use other technology platforms on the more general basis. So that is meant, but there has been a roll out of multiple platforms in the outpatient space, and we’ll come on to the state of, I think has really affected both a cultural attitude in hospital setting to using telemedicine as a means of treatment for patients. Next slide, please.

So, I think there’s some key considerations in the UK space, the first of which I have mentioned already, which is the Care Quality Commission, which is the regulator for all registered healthcare providers. It’s a criminal offence to provide healthcare in the UK without being registered with the CQQ. The Care Quality Commission has specific registration requirements for online and remote healthcare providers. Now what is interesting is that, in this so far, given the developments in the UK that has largely focused on primary online health care, and it will be interesting to see whether the registration and inspection requirements of the CQQ need to be changed to reflect the adoption from 200 to 6000 a day of remote telemedicine consultations in the secondary care in the hospital space. We also have some, as with all other European countries, specific rules around data protection on patient confidentiality, and a series of rules and recommendations in respect of the ability to use platforms to protect patient confidentiality and to ensure that consent is adequately recorded. So moving slightly on from healthcare itself to pharmacy and e-prescription, again, in the UK, there is a pretty well-developed regulatory framework for online pharmacies and an established mechanism for the provision of electronic prescriptions. The first thing to note about that is that any pharmacy can register to remote deliver pharmacy services, but they must be registered with the MHRA. They must comply with the electronics directive, and they must also be registered, and have the logo, the MHRA online pharmacy logo on every webpage that they use with the public. In addition to the MHRA, the Royal College of Pharmacists has also issued a scheme and recommended guidance, which was issued again in 2019, which sets out a number of provisions for pharmacies. Now, some of that, some of our Royal College guidance came about through concerns about patients being able to access unlawfully prescriptions online and for some concerns about that, kind of, false medicines. But the regulations and the restrictions on that are pretty well known and very well published. And the Royal College also has a crack mark, a voluntary scheme, which many pharmacists have adopted alongside the MHRA registration. Many of the UK platforms operate both healthcare and pharmacy on one platform, and I know that that’s a distinction in the UK from other countries in Europe, particularly in France. And what is interesting about that is that, in that case, both the doctor must be registered with the Care Quality Commission and the pharmacy must separately be registered with the MHRA and with the appropriate pharmacy bodies. As I mentioned earlier, the NHS has already moved to an electronic prescription scheme and our legislation, our medicines legislation has included, for several years now, two rates of electronic prescription. The first is the NHS electronic prescription service. And, again, alongside the digital, kind of, move, the move to digital care, particularly in primary care, has been a significant amount of technology investment into the electronic prescription service. In October 2019 it was estimated that 70% of NHS prescriptions were sent from the doctor to the pharmacy using the electronic prescription service. And there are a number of external players that providers that have, that have met the requirements of NHS Digital, which runs the service and the requirements in respect of cyber security, security in respect of data protection and patient confidentiality. And the specific requirements, particularly in relation to advanced electronic signatures, which are required for the use of the electronic prescription service. So, in addition to the NHS electronic prescription service, it is possible to send other prescriptions electronically. So, in a private setting a patient may have a prescription sent electronically from the pharmacist, from the doctor to the pharmacist. And that must, again, comply with our medicines registration regulations and include specific requirements on advanced electronic signatures. There are also specific requirements on the delivery of medicines, from online pharmacies to patients in their own homes. As you might expect, those largely relate to ensuring it’s the right person who’s getting the drugs and ensuring the safety and delivery. So, in practice we have already moved quite widely to an e-prescription service and the rollout is now almost on the last phase, with doctors this year and next year being obliged to move toe electronic prescriptions when they prescribe to patients. Now the interesting and final point on my slide is relating to medical devices. Now, in this regard, we probably lag slightly behind Germany, which has introduced the reimbursement for medical apps and technology. At the moment that there is some question about how apps technology and AI will be reimbursed. And although we have an extremely active medical device sector, the reimbursement regime is moving along a little slower, possibly, than some of the technology. In our NHS tariff this year, a specific consultation was launched. So, it launched at the end of last year, an innovation and technology tariff which proposed that apps and technology would be subject to a reimbursement regime. But one of the regrettable impacts of COVID is that, that, that consultation has not concluded, and we are yet to have a clear reimbursement. What is interesting about our proposals, though, is that it looks to the medical device and suggests that there may be appropriate cases where the medical device may be reimbursed by the payer or the commissioner, where the benefit is for the commission payer. For example, where there may be benefits for public, the public as a whole, so population health tools and those tools that might benefit the provider. Where the technology is seen to benefit the commissioner, it is proposed in an outline that the technology would be paid as pass through, so the commissioner would pay that on top of any amount that they pay to their healthcare provider, whereas if the technology benefits the hospital, that would need to be reimbursed by the hospital. In addition to the proposal in that consultation, there was also a proposal that they would need to be a nice, so the Institute of Clinical Excellence, evaluation of the effectiveness of that technology. Now my concern about that is that we’ve had some delay with COVID, but also that that that appraisal process for drugs and for other devices can sometimes be seen to be complicated and to take too long. And I’m slightly envious of the German reimbursement for medical devices and hope that post COVID we move are rapidly to a reimbursement system that matches elsewhere. And I’m happy to take questions later in today’s session on anything else that you would like to discuss.

Sorry. Good evening and thank you, McDermott to organize the webinar and to give me the opportunity to join. And, next slide, please.

There are no laws, national laws, in Italy, specifically directed to telemedicine. In 2014 the conference made by representative of the government and region connected National Guidelines on Telemedicine in that is a … document that provides first, distinction of whether telemedicine either and the main requirements to perform it, both within the national the National Healthcare Service and outside. And this document is currently under review, but we don’t have evidence of a specific deadline for the completion of the revision. The guidelines provide for several categories of services fully within the definition of telemedicine, telemedicina in Italian. In particular before we focus on the televisita … since they are the more common. Televisita is a medical activity in which the doctor interacts remotely with the patients. It’s interesting to highlight that the visit can give rise to the diagnosis and the prescription of drugs or treatments. In addition, the connection that must allow to see on the interact with patient. Telesalute is the services that puts a patient in direct connection with the doctor through a remote telemonitoring over there and vital apparent person. And these activities usually of course, of course, with the support of devices, apps, and similar. Next slide, please.

National guidelines that provide for a number of requirements for telemedicine services. In particular, gatherings mentioned technological requirements, professional requirements, organizational, and clinical. Now we focus on technologic requirements, and since they are the more peculiar to this category of services. In particular, guidelines focus on, they need to assure security for citizens, which particular, regard to the verification of the source of the information. So identification, the protection of information from possible unauthorized accesses, or, in general protection of the confidentiality of information and provided by the… As mentioned, before, since that software and the apps are often used to support the telemedicine services is of course very important to assess carefully whether these apps or software can be classified as a medical device under the, now, there and now in the next future, next year will be the under the new regulation. Of course, the difference with the path, the procedural path needed to put them on the market, vary depending on the outcome of this assessment. Whether the software or the device is a medical device or not. Another topic assessed by the guidelines concerns informed consent. In particular, guidelines say that it’s necessary to evaluate do we need or not to repeat the consent for each service. For instance, for each service provided by the same platform or same entity or just to be, the purpose is to be sure that the patient is absolutely aware of the characteristics of the services provided, of course, remotely. And for the same reason, the patient must be informed of the specific risk that may be connected with the user of telemedicine services. So, not a traditional visit. In recent … for consent specified that the consent may be documented in writing or through a video recording. And this is an opportunity that can be also used it in the constant, the context of telemedicine services. Next slide, please.

And then, the finishing of the guidelines, telemedicine is considered not a separate medical specialty, but a difference to, to provide traditional healthcare. Therefore, private entities, private healthcare entities intending to carry out telemedicine services shall meet the same requirements as those necessary for traditional healthcare services. Such requirements are different depending on whether services are provided at the National Healthcare Service or paid by, directly by patients. In particular, for, for services provided under the National Healthcare Services, the facilities need to receive two different authorizations. One, to build the facilities, and the other one to operate healthcare services from the region. Then they have to be accredited for the region after having assessed a specific and additional … And then they have to execute contracts with the local health authorities that have to quantify and specify the services that can be provided to patients and … by the National Healthcare Services. Starting from 2017, certain telemedicine services have been included in the list of essential healthcare services to be granted to all Italian patients. This this was, of course, a big news for, for the system for telemedicine but we have a great difference of the user implementation of telemedicine services between Italian, from an Italian region to another one. Not everybody has the telemedicine implemented at the same way. However, the COVID emergency have boosted with development of telemedicine services. For instance a couple of weeks ago, the Italian regional enacted the, a decision to incentivize the use of telemedicine services at the National Healthcare Service expenses, of course, to face the emergency. And so, the increased demand of remote consulting by patients. As to the private service facilities, the private facilities that intend to provide healthcare services at patient expenses just need to receive the two authorizations mentioned above. And so, to build, authorization to build, of course, and then to operate and the services. And now the question is, in the case of telemedicine, what activities shall be authorized? Next slide, please.

We received the first answer for these questions by a recent decision of the Criminal Courts of Cassation, so the last … Court in Italy, in 2019, according to the court, the place where data are collected from a patient and transmitted to a healthcare facility for the purpose to be assessed does not require to be authorized by the competent region, since no medical activity is carried out therein. Indeed, according to the court, the medical activity is not carried out where the data are simply collected from patients, provided that such collection of occurs by means of noninvasive instruments that can be used directly by the patient without the specific need or the specific system of healthcare professionals. For instance, the blood pressure. In addition, the court said that the place where medical activities is carried out needs to be authorized only if it is an organized entity aimed at performing medical services. That means that, for instance, it’s not, authorization is not required for healthcare professional work in private offices not open to public where the intellectual work prevents over organization and the… This is important for telemedicine. We can, we can refer to a principle from this decision. First one is that is necessary to assess where medical devices that is actually carried out to us to, to say, if an authorization is required or not. And second, no authorization is needed only for telemedicine if that activity does not require authorization. So, telemedicine itself does not required the authorization of a doctor. Next slide, please.

Okay. Recently, strong the input to the development of telemedicine services that has been given by the dematerialization off their prescription for the supply of medicines and …. Indeed, if the scriptures were already introduced by considered degree of 2011 and … through a dedicated website where both doctor and pharmacist can access. However, such a… in ministerial decree of 2011 required the issuance off a paper memorandum of the prescription to be showed to pharmacist for the collection of the medicine. And, that and the other, very important, it did not apply to prescriptions concerning medicine to be provided at the patient’s expenses, but only at the National Healthcare Services expenses. Now, we have very important amendments of these rules. In fact, the paper memorandum of the prescription is no longer required, thanks to an urgent ordinance issued to face, the COVID emergency crisis. So, in the current situation, the patient can only communicate the number of a prescription to the pharmacist to get the medicine. And this rule was confirmed by a ministerial decree that was already enacted on 25 March, which will apply starting from the end of the emergency. So, just to say that these rules has been now confirmed for, forever. Then the other important new news is that for the e-prescription now can be applied also to medicines and services to be paid by patients. So, not only for medicines supplied at the National Healthcare Services expenses. So, it’s really a very important booster to the development of the healthcare digital process in Italy, because now it’s possible to imagine a system that will, from the tele visit with, you know, with the… and, and the issuance of the e-prescription. And then it’s communication to pharmacy that can then implement a system to bring the medicine directly to patients. And this was, this was not, you know, it was difficult to imagine in Italy before what happened in the next few months. Thank you.

Hello. Thank you very much. Thank very much to McDermott for inviting me to this webinar. I think this is very interesting, this is something that we will see in the future. While in Spain, the vast majority off healthcare services are performed by public providers. And well, in Hispanic public administrations are advancing at the very, very slow pace in regulation on implementation of telemedicine. So while telemedicine is supplied in the private sector and not so much in there in the public sector. And well, it is true that and Spain has not regulated telemedicine so far. And there are only Soft Law, and we have, for example, significant limitations to virtual consultations. And in the in the codes, in the code of ethics of medical doctors, and, and these imitations and in are that there is no possibility to actual diagnosis without an on-site visit. So the online channel is only available for an initial assessment. For example, a triage activity, and also for a second medical opinion. And it is also possible for follow up activities for patient monitoring and also for follow up prescription. And in Spain, also, there are no specific professional duties and obligations for online visits. They have the same professional standards and same requirements as they have for an on-site visit. And before, well, the medic—the healthcare professionals have performed these kinds of services must be … in Spain and must be registered in the Official College of Doctors. In addition, while the rules of confidentiality, the Lex Artis security and professional secrecy, all that requirements must be complied with. And also, and it’s very important that the identification of both parties, doctor and patient, must be perfectly done in, in this remote visit. So and the patient must provide its informed consent to practice this kind of security, this medical assistance on remote. But, well, in, although there is no expressed legal regulation, there are many rules I’ve set out in these slide that shape and limit the possibility of these removed medical assistance. And, please, next slide.

And, so there are many, many issues that must be bear in mind. And I’m going, just because we are, we don’t have much time, we are only, I am stress three points. One is the medical data. In this patient medical data are sensitive data and they must be treated with a lot of care. And the GDPR are all the rules for, for medical protection must supply in its whole. That also applies for a storage of personal data and for the clinical records that must be protected and must be stored for at least five years in Spain. On there’s another important, important matter which has already been discussed in the previous presentations. And the, the, it is the medical devices issue. And this digital health solution, some of them need to be validated because their proposes are medical proposes. So this is very important for, for all the software, all the elements that support the remote medical assistance may need to be a classified as medical devices and to for obtain this CE mark under the decoration of conformity. This is, this is some, some issue that need to be taken care of with, with a lot of detail. And regarding also these medical devices that’s very important, liability issues that may arise from the use of medical devices. For example, medical devices that help diagnoses. Those devices that may be supported by artificial intelligence, for example, and need to be taken care of in regards with to liability because, while there is some restriction in liability in Spain regarding defective products, but it will apply to medical devices and to all the products related to, to them. And next slide, please.

And well, and what do we see in practice in Spain? And, well, it is, as I’ve said before, in the public, the public system has not implemented telemedicine, mainly. This is generally applied in the private sector, and it is, they are in the insurance companies are the ones that are fostering these developments of telemedicine, which has been, it has boost a lot regarding when in this COVID 19 crisis. And we have seen an increase in virtual consultation during the crisis. There, there are other categories or ways in which this virtual consultation is developing in Spain. We have a websites and apps that are resolving questions on implement mechanisms for a medical chat between doctors and patients. And regarding public sector, there are some areas in which the public sector is working in its implementation, implementation some elderly monitoring services. Also, some radiotherapy, tele radiotherapy, and also in a lot of assistance for other health professionals. And there are some services, for example, … area where different specialized doctors are helping other hospitals in the, in the development, the developments, sorry, of strategies and against this kind of diseases. And next, please.

So, regarding a reimbursement and, well, the National Healthcare System, and is that the, the main, is not generally possible to obtain this reimbursement from the National Healthcare System. So and that’s why telemedicine is not, right now, being implemented in the, in this, in the system, since it is mainly in the private sector And however, it is possible in the, in the collaboration agreements that sometimes the Spanish healthcare system signs between with private care operators. So, there are some, some cases in which reimbursement is possible. But aside from that, telemedicine services are mainly now in the private sector. And the private insurance funds are paying for those, for those services and that will depend on the, on the contract that this insurance has with a patient. And now, well, there are, this insurance companies are starting to create the round platforms, not just platforms that are located in the hospitals or in the healthcare providers, but insurance companies are creating the round platforms to provide telemedicine services. This is one of the, of the trends that we have seen right now. And next, please.

And regarding e-prescription, well, in Spain, it is possible, online prescription exists in Spain. There are, however, certain limitations. Well, the first limitation is that the … before dealing the ontological codes for health care professional. That’s not allowed, do not allow are for in prescriptions that aren’t on in the first area in an online visit that establish diagnosis. This is not, this is not possible. However, it is possible online prescription for a renewal prescription. So it is possible in follow up visits to obtain these online prescriptions. The only prescription system was, was approved in 2011, and now it’s implemented in the whole National Healthcare System. So for, for public system exists this online prescription. And also it is possible to establish for private healthcare providers approved electronic prescription system that must be approved by the College of Doctors and must be implemented between doctors and pharmacies. This, the requirements for these electronic systems are that they must be encrypted. This is, also they also must contain all the patient data and they must have a specific code or indication number of the prescription. This this identification number must be unique for its prescription. And well, these kinds of systems and must allow the pharmacist to block the dispensation if he considered that this is, there are manifest error or there’s safety alert or whatever the reason. And also, the, the prescriber, the doctor that has prescribed this medicine can see if the medicine has been, has been dispensed or not. So this is a very, very well-prepared system. And I think it’s working a quite well in Spain. And well, that’s all. I don’t know, if you have any question, I will be glad to answer.

Thank you to all speakers. We received some questions through in the last hour, which we like to transfer now. The first is for Elisa and also for Irene in Spain. Just start with Elisa. May a patient ask online for the delivery at home of prescriptions, medicines?

In Italy, in Italy, prescription, prescription medicine cannot be sold online. So, they can be sold the only in the pharmacy. Provided that, it’s, it’s possible. And many pharmacies may, are, are implementing this system, and may, you know, implement organize a mechanism where, you know, a person can go there and … and collected the medicine and then bring it to the patient… So, it’s not an online sale because it’s forbidden under Italian law, but it’s a service to, it’s a service of delivery of prescription drug. This is allowed.

And the same question has been asked also for Spain. Irene?

Yes, yes. Thank you, Karolin. Well, if for Spain it is almost the same but with, with a difference. Well, prescription medicines cannot be sold online, and it is not possible to, to do this kind of, of service of home delivery if for a third party, the pharmacy itself could send the medicine. But this is something that it is, it is not very clear under Spanish law and there is a general provision that prescription-only medicines could be say, could be, could be sale of online. And also, that could be sent to the home of the of the patient. So this is very, very restricted.

Okay, Thank you. And the next question is for you, Sharon. They asking that there was a very quick development of digital health in the UK and do you think it will continue and become commonplace for care in the UK?

Yeah. I think that especially in primary care we were already well on the way, and the adoption rate has been very high. Together with the incentives of the GP contract, I can see that that will probably be adopted quicker. In the hospital space, I think that will be interesting to see how we respond and how the country as a whole reacts, you know, recovers from COVID, to the extent that patients are feeling reluctant to come into a hospital setting and still want to receive care remotely, then clearly that is going to influence the adoption. But certainly we’ve overcome some significant cultural barriers and just the, kind of, experience of having a telemedicine through for outpatient appointments has been helpful. There will be some specialties where it is more difficult to adopt remote care, particularly, say, for example, in some orthopedics, possibly spine surgery, some other disciplines. And, I think that then, will be affected by some of our delayed waiting. So, at the moment, it’s estimated there are approximately 7 million patients who have had delays to their care, and every month that continues, that, that’s going to increase. So with an estimate around August of about 10 million people waiting for care. Now, if telemedicine can be used to help support, kind, of the access to care and triaging, I think that will be a significant, kind of, continuation of the COVID response.

Thank you, Sharon. I think we have time for just one other question. I will select one for France. And France, do we think that the COVID 19 pandemic will accelerate development in the general exceptions of teleconsultation in France? Anne-France, can you, can you answer the question?

Sorry. I’m on mute. Yes, of course, in practice, since the use of teleconsultation apps as dramatically increases since the COVID 19 pandemic. But from a legal standpoint, is loosening requirements due to the COVID 19 pandemic, will cease to apply. And the market, will only be available to players who comply with the security requirement, as I described earlier.

Okay. Thank you. Well, I think we are running out of time. Thank you again for sending questions and your positive participation at this webinar. Take care, and all the best. Bye.


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