09 Dec Evolution of legal framework to catalyze digital transformation of healthcare
The Young Executive Leader Initiative of the International Hospital Federation (IHF) is an opportunity for young executives from hospitals around the globe to meet with one another, discuss current trends and challenges, and offer perspectives from their experiences. This year, there are 16 leaders in the program, and the following group will be focused on digital enablement of healthcare and the challenges and opportunities of being a digital leader in a post-COVID world. You can find more information about our program here. In our preceding articlse, we highlighted some of the benefits of patients using digital tools in healthcare like the ease of access, as well as the challenges like interoperability. We Have then focused on the adoption by healthcare professionals. Finally, for our last article, we will present evolution of legal framework to catalyze digital transformation of healthcare, by focusing on examples from Portugal and Germany.
Authors: Kuhlmann, L. (Germany), Staudt, J. (Germany), Tsai, M. (Taiwan) and Veloso, R (Portugal)
While entering the digital era, much improvement has been made in the field of information and communication technology (ICT). Our daily life is filled with various digital products and solutions. As medicine is a highly specialized field with high risk and uncertainty, the legal regulations about healthcare are usually stricter than those in other fields. With a high probability to quickly implement the modern technology in our healthcare systems due to the pandemic, an up-to-date legal framework is required. The digital health solutions which did not fit in older legal framework require legalization. In addition, the evolution of legal frameworks should be taken to catalyze digital transformation of healthcare. Herein, we summarized the evolution of legal frameworks of telehealth and e-mental health in Portugal and Germany as examples, trying to demonstrate the kinds of legal environment we need to catalyze digital transformation of healthcare.
Example 1: Portugal – The importance of a legal framework to improve Tele-Health
Telehealth in Portugal: Temporal Evolution
The first telehealth activities on public record took place in 1998 with the creation of the telephone helpline “Dói, Dói? Trim, Trim!” and the teleconsultations in the area of pediatric cardiology at the Pediatric Hospital of Coimbra. In 1999 a telemedicine network was built between primary and hospital health care in Alentejo. Later in 2005, the helpline “Dói, Dói? Trim, Trim!” gave rise to “Linha Saúde 24”. Subsequently, several regulatory and operational actions were prepared, including the publication of the Directive 2011/24/EU on Cross-Border Health care, which includes the increase in the price of teleconsultations, the creation by SPMS of the Telemedicine Working Group (GTT) integrated in the Monitoring Committee for Clinical Informatization (CAIC), the preparation of the Teleconsultation Roadmap, the development of the PDS Live platform, the creation of the Clinical Guidance Standards (NOCs) within the scope of telemedicine by the Directorate-General of Health, the definition of the Telemedicine Framework Agreement, the establishment under the SPMS of the Portuguese National Centre of Telehealth (CNTS), according to the Resolution of the Council of Ministers no. 67/2016 of 26 October, and, finally, the creation of the SNS Contact Centre (SNS 24), which has been under the CNTS’s responsibility since July 2017. Telehealth is currently growing with multiple projects, mainly local and in the pilot phase. There is a clear need to scale in a coordinated manner by replicating good examples and to benefit from national coordination and strategy, from planning to implementation and monitoring.
- Local Committee for Clinical Informatics
These Local Commissions, were approved by Order No. 3156/2017 of the Office of the Minister of Health of April 13, and are constituted by a multidisciplinary team of the Hospitals whose competences are to develop a local action of management of change, with a view to computerization, through the definition of implementation strategies, promotion of good practices of electronic clinical record and, also, articulation with initiatives of Telemedicine.
- SPMS & CNTS
Shared Services of the Ministry of Health, EPE (SPMS) was created by Decree-Law no. 19/2010 of 22 March and amended by Decree-Law no. 108/2011 of November 17, Decree-Law no. 209/2015 of September 25, Decree-Law no. 32/2016 of June 28 and Decree-Law no. 69/2017 of June 16. Its mission is “to provide specific shared services in the health area and in the areas of purchasing and logistics, financial services, human resources, information and communication systems and technologies and other complementary and subsidiary activities, to all SNS establishments and services, regardless of their legal nature, whether E.P.E.s or Public Administration Sector (SPA) entities, as well as to the bodies and services of the Ministry of Health (MS) and any other entities when carrying out activities in the health field” (SPMS, 2018). Being so, SPMS plays a relevant and responsible role in the digital transformation of the health area. It is responsible for technological products and services (link to our first article) for citizens, professionals and health institutions. The Portuguese National Center of Telehealth (CNTS)  was created according to the Resolution of the Council of Ministers (RCM) no. 67/2016 of October 26 and was integrated into SPMS by the Decree-Law No. 69/2017 of June 16. It acts to promote, manage and coordinate the telehealth services and initiatives and carries out Research & Development (R&D) and tele training activities. The CNTS mission is to “facilitate the citizens’ access to health, to ensure its equity and to increase the efficiency of national resources by taking advantage of information and communication technology” (CNTS, 2018) and its vision is “Health without space and time barriers” (CNTS, 2018).
- National Strategic Telehealth Plan
National Strategic Telehealth Plan (PENTS 2019-2022) is a proposal from the Shared Services of the Ministry of Health, E.P.E. (SPMS) under the coordinating scope of the Portuguese National Centre of Telehealth (CNTS) as defined in the Resolution of the Council of Ministers No. 67/2016 of October 26. Being the first strategic plan for telehealth carried out in Portugal and one of the first in the world, its vision is to create a broad strategy that reflects the role of telehealth in the National Health Service (SNS) in harmony not only with the National Health Plan Revision and Extension to 2020, but also with the Programme of the 21st Constitutional Government and the Health 2020: the European policy framework and strategy for the 21st century (WHO). EHealth, telehealth and telemedicine are currently areas of growing importance in the context of a health sector highly pressured by external factors such as economic, financial, political-legal, demographic, technological, educational, socio-cultural and organizational. The objective of PENTS is to define a strategy to leverage the telehealth, taking advantage of Information and Communication Technologies (ICT), as valid means in the management of health and its services. Consequently, the use of telehealth should boost the development of the health sector in Portugal in terms of health gains and quality of life, as well as operational efficiency.
Telehealth offers new answers to major challenges, namely those of accessibility and proximity to health care, integration of care, training of citizens, patients and caregivers in the SNS, among others, remaining an important catalyst of digital transformation in healthcare. PENTS should be seen as an instrument that integrates the strategy for the development of telehealth and whose main objectives are the elaboration of a current vision of telehealth in Portugal, by listening to experts and key institutional stakeholders on the subject, as well as by analyzing relevant documentation.
- National Strategy for the Health Information Ecosystem
The National Strategy for the Health Information Ecosystem (ENESIS 20-22) was approved by the Resolution of the Council of Ministers No. 62/2016 of October 17, and aims to create the framework and conditions through which the different actors in the Health System can contribute to the evolution of the Health information ecosystem, becoming a reference of good practices and promoting the delivery of benefits and the optimization of risks and resources. This approach goes beyond the NHS and extends to the entire Health System in alignment with the Basic Health Law, approved by Law No. 48/90, of August 24, until it reaches the personal and autonomous use of the citizen. The result is a common vision for the area of Health Information Systems and Technology that allows to guide the strategies and initiatives of the different actors of the ecosystem in order to progress collaboratively or independently towards common goals.
- Mandatory use of telehealth during COVID-19
The mandatory use of telehealth, was approved by Order No. 5314/2020 of the Office of the Minister of Health May 07 and determined that the performance of the care activity occurs using non-face-to-face tools, using telehealth mechanisms, namely tele screening, teleconsultation, telemonitoring and teleconsultation programs, except where this is not clinically adequate or technically possible. Since the beginning of the year 2020, there has been a 65% increase in teleconsultations compared to 2019 in Portugal.
Example 2: Prescription and invoicing of certified e-mental-health applications in Germany – Legal framework and initial experiences from outpatient departments of Vitos clinics
(Laura Kuhlmann / Jonas Staudt)
In December 2019, the “Law for Better Care through Digitization and Innovation” (Digital Supply Act – DVG) was published – a true milestone for digital treatment in Germany. The law addresses two major aspects.
First, doctors and psychological psychotherapists are able to prescribe certified health applications paid by the health insurance companies. The manufacturer of digital health applications have to send out an application for approval in order to be listed in the official “digital health applications directory (https://diga.bfarm.de/de/verzeichnis). The Federal Ministry for Drugs and Medical Devices is responsible for validating these digital health applications with regard to content, data security and proof of medical studies. For the manufacturers, there are several requirements, which they have to fulfill. As soon as the digital health application is listed in the directory, doctors and psychological psychotherapists can prescribe it by using a special prescription form, which the patient takes to his or her health insurance company. Then, the health insurance company gives the patient a special code, which is used to gain access to the digital health application. The health insurance companies pay the manufacturer of the digital health application and the patient is able to use the certified content of the application. To this day, those digital health applications do not offer a technical solution for doctors or psychological psychotherapists to have a look into the patient´s activities within the application, as the listed digital health applications are programs for self-help. Thus, the blended-care-approach has not yet been considered.
As a second point, the law facilitates video consultations for doctors, psychological psychotherapists and as well for patients by allowing the practitioners to do the educational talks as well by video. In addition, the law formulates that patients have to be able to find out easily which doctors and psychological psychotherapists do offer video consultations.
Initial experiences from outpatient departments of Vitos clinics
Vitos has several outpatient department in the federal state of Hessen, which focus on psychiatric and psychosomatic diseases. The outpatient departments of Vitos clinics contribute to an important part of psychiatric healthcare. Each outpatient clinic has a multidisciplinary team including certified child and adolescent psychiatrists, nurses, social workers, and psychologists. They provide professional care to patients, who suffer from severe psychiatric disorders. Patients make use of diverse services like psychological diagnostics, psychopharmacological treatment, medical consultations, group therapy, ergotherapy and comprehensive treatments for many mental health disorders including depression, anxiety disorders, posttraumatic stress, psychosis, disruptive behaviors, substance use disorders and eating disorders.
Especially for mental health patients, finding the right outpatient treatment plan is critical. Outpatient care should only be applied when constant support is unnecessary, and it is healthier for the patient to remain in their environment to experience stressors and learn to cope with professional guidance. Typically, patients come to our outpatient clinics for treatment sessions up to twice a month on average. But what will happen between the medical appointments?
Growing evidence attests to the efficacy of web-based e-mental health services and Internet-assisted therapeutic tools (Andersson et al., 2014). In the sense of a state-of-the-art approach, these treatments should be embedded within the existing health care system as part of a continuum of mental health care and alongside face-to-face-treatments and pharmacotherapies.
Perspectively, Vitos outpatient clinics will prescribe certified self-guided internet-based interventions and e-health applications listed in the official “digital health applications directory in addition to face-to-face-treatments at a higher percentage. Initial experiences were gained at this point in time.
On its own, e-health applications are not appropriate for immediate help, such as medical or psychiatric emergencies that requires immediate care or when an individual is battling suicidal thoughts in the case of a mental health emergency. Therefore, blended care is one potential option for people who have limited access to conventional face-to-face counseling, offering continuous support and greater flexibility for the patient.
There are lots of different digitally based modalities that could formulate a blended care solution, including:
- Online psychoeducation and digitized treatment plans
- Internet-based cognitive-behavioral therapy (iCBT)
- Self-paced online learning modules
- Scheduled video consultations with a therapist – either to provide feedback on progress or to replace a traditional face-to-face session
- Progress monitoring apps, including data monitoring and health information from wearable sensors (for example step counters)
Summary – Status quo of e-mental health in Germany:
The use and value of internet-based interventions, e-mental health applications and telehealth tools such as video consultations have grown during the COVID-19 pandemic in Germany.
Since May 2020, there are no limitations on the number of cases and amount of services that can be provided via video consultations by every outpatient clinic of Vitos. But video conferences are only one part of „state-of-the-art“ outpatient treatment. Furthermore, mental health patients can be supported by certified health applications to maintaining healthy habits and learning how to cope with daily life.
The professionals working in our outpatient clinics try to find supportive health applications that meet the needs, abilities, and desires of a patient. Therefore, online and face-to-face elements of therapy should be related to one another. These are the first steps to involve certified health applications in clinical trials. Further research is needed, and professionals should gain more experiences in applying and prescribing e-health-tools.
The introduction of digital health care solutions needs consideration on many different areas. A legal framework to catalyze digital transformation of healthcare is crucial in order to implement digital solutions. Due to the character of digital solutions, a legal framework should give orientation and clear rules by facing the fact that digital transformation needs ongoing innovation and development. Therefore, development and enhancement have to be taken into consideration to continuously improve digital actions in the health care sector.
The legal framework should also take into account the quality of digital health care measures and the evaluation. Digital solutions must have the same impacts on patients as non-digital solutions. Therefore, the digital solutions have to go through similar quality checks. With regard to the law in Germany, there are financial incentives for those hospitals who are willing to digitize their processes. However, there are as well financial sanctions for those, who aren´t interested in improving telehealth and e-mental health services. The legal framework has to offer strong guidance in order to gain significant experiences and valid results. Simultaneously more research is needed to find evidence for the health economic potential of e-mental-health and telehealth solutions.
The basis of telehealth is not technology. The essence of medicine is not in any product. It is in the patient, the healthcare professional and his Code of Conduct. It is in the uncompromising fulfillment of this same Code, which reminds us that “telemedicine must respect the doctor-patient relationship, maintaining mutual trust and empathy, the independence of the doctor’s opinion, the autonomy of the patient and confidentiality”. Ethics and deontology can accompany society, but they are not mere applications of automatic inputs and software. And legislation, regulation and governance play a key role in this new era of care.
Behind every law that is a face, a person (or group of persons) who fight for it and try to make it happen. The main challenge is how to audit and ensure that these laws are complying and that fair penalty mechanisms are applying for non-compliance.
 Entity created by the Dispatch No. 9725/2013 of July 24
 Instrument enabling the acquisition of telemedicine goods and services. In service since December 7, 2016
 Creation by Decreto-Lei 69/2017 of June 2016
 Perceptions and information collected through interviews and surveys to institutional stakeholders in the healthcare sector and telehealth experts.
 Portuguese National Center of Telehealth (2018). National Strategic Telehealth Plan 2019-2022. http://www.cnts.min-saude.pt/wp-content/uploads/2019/12/PENTS_EN.pdf
 Andersson G, Cuijpers P, Carlbring P, Riper H, Hedman E. Guided Internet-based vs. face-to-face cognitive behavior therapy for psychiatric and somatic disorders: a systematic review and meta-analysis. World Psychiatry 2014 Oct; 13(3), 288-295.
 Guimarães, M. (2020). Óleo não é azeite – Associação Portuguesa de Telemedicina (aptelemedicina.com)