LEGAL ASPECTS OF THE USE OF TELEMEDICINE 1
Arman Anwar2
Faculty of Law, Universitas Pattimura, Ambon
ABSTRACT
Entering the 21st century, the world is faced with the emergence of new technology in the medical field which memunpossibledoctor to bepracticein virtual space. This innovative technological revolution is known asTelemedicine.Thanks to telemedicine, medical services can now be provided via telecommunication, audio, visual and data that can connecting facilitiesservicen healtheven though in geographically separated. Therefore, differences in time, place, and distance are no longer obstacles to the therapeutic relationship between doctor and patient. In the next millennium, this type of healthcare is expected to develop rapidly, and in Indonesia, the development of telemedicine has been accompanied by regulatory readiness in several countries.
BUnlike Malaysia, India, or the United States, Indonesia does not yet have a law specifically regulating the use of telemedicine; it only regulates telematics in general.. In addition, the creation of regulations regarding e-health has not been as we expected, even though electronic-based health services (e-Health) have actually been recommended by the World Health Organization (WHO) since 2005.
In addition to the benefits obtained from the use of telemedicine, it is also necessary to be aware that the use of telemedicine also has the potential to cause various legal problems, both at the national and international levels, such as licensing or permitting issues for doctors or medical personnel who practice telemedicine to patients in Indonesia or abroad, accreditation of medical service facilities and equipment, informed consent, security and confidentiality of patient health information data (medical records), standard operating procedures and insurance issues, as well as liability in the event of medical malpractice.
The real conditions and implications of the legal issues regarding telemedicine above should ideally be regulated in national law, so that it can provide legal certainty in responding to the demands of the development of telemedicine medical technology.
Keywords: Telemedicine, health services, legal implications and legal certainty
- Proceedings of the Indonesia Health Informatics Forum 2013, International Seminar in Dian Nuswantoro University Semarang, April 22-24, 2013
- Lecturers Faculty of Law, Universitas Pattimura, Ambon
- PRELIMINARY
1.1 Background
Indonesia has the sixth largest population in the world, reaching 203.456.005 people.1 with a poor population of 13,3% (2010).2 This has caused health problems to become one of the main issues in Indonesia. According to Progress Report in Asia & The Pacific published by UNESCAP, Indonesia is still experiencing delays in the process of realizing the achievement of the Millennium Development Goals (TMP)/Millenium Development Goals (MDG). This is evident in the still-high maternal mortality rate, the low quality of sanitation and clean water, the increasingly difficult-to-control rate of HIV/AIDS transmission, and the ever-increasing burden of foreign debt. These sectors clearly impact the quality of life of the Indonesian people, as manifested in Indonesia's declining ranking in the Human Development Growth Index as of 2010. In 2006 Indonesia reached 107th place in the world ranking, 2008 at 109th, and from 2009 to 2010 it was still at 111th place. A difference of 9 places with Palestine (West Bank & Gaza Strip) which is in position 101.
Currently, the doctor-to-doctor ratio in Indonesia is still one per 5.000 people. In comparison, Malaysia has a doctor-to-doctor ratio of one per 700 people, ensuring adequate patient care.
Another challenge facing Indonesia is its archipelagic geography (17.000 islands). Therefore, placing specialist doctors across all the islands presents significant challenges. Most specialists prefer to be located in large urban centers, particularly provincial capitals. Residents in districts, sub-districts, or villages, especially those in border areas, inevitably have to settle for non-specialist doctors or even paramedics and nurses.
The disparity in healthcare services and the uneven distribution of doctors, especially specialists, in Indonesia are difficult obstacles to overcome. Despite these challenges, Indonesians are still quite enthusiastic about seeking medical treatment abroad. The Indonesian Doctors Association (IDI) chairman stated that nearly 1 million people seek medical treatment abroad annually, with the amount spent on medical expenses reaching Rp 20 trillion.
This situation, whether consciously or not, severely complicates the government's efforts to improve health development in Indonesia. Yet, health development has a crucial goal in national development efforts: to increase awareness, willingness, and ability to live healthily for everyone, thereby achieving the highest possible level of public health, and as an investment in the development of socially and economically productive human resources.
To address the health crisis in rural and border areas of Indonesia, as described above, a method is needed that can address the problem effectively and efficiently. The strategy adopted is an unconventional healthcare model where doctors and patients do not meet face-to-face but are instead connected through information and communication technology called telemedicine.
In addition to the benefits obtained from the use of telemedicine, it is also necessary to be aware that the use of telemedicine also has the potential to give rise to various legal problems. Some of these legal problems include: licensing, accreditation, privacy and confidentiality of patients' electronic medical records, liability in the event of malpractice, clinical guidelines, and insurance.
Learning from the experience of several countries, it is known that Malaysia has made a Law on Telemedicine with the name Telemedicine Act 1997. India also has a Telemedicine Act under the name Telemedicine Act 2003. Meanwhile in the State of California, United States, based on the approval of California Governor Brown on October 7, 2011, the Senate has ratified Telehealth Advancement Act of 2011 to replace Telemedicine Development Act of 1996.
The empirical reality and implications of legal issues surrounding telemedicine in Indonesia require national legal regulations. Allowing changes and developments without corresponding adjustments to the legal regulations is tantamount to leaving those changes and developments in a state of uncertainty and disorder. Therefore, it is time for Indonesia to have national regulations on telemedicine to provide legal certainty for both healthcare practitioners and patients using telemedicine services.
1.2 Formulation of the problem
Problems to be studied and at the same time become legal issues 4 is :
- Characteristic Telemedicine in medical practice
- Legal principles of use Telemedicine in medical practice
II. RESEARCH METHOD
2.1 Problem Approach.
The research conducted is legal research related to academic activities. This research differs from legal research related to practical activities, which is more directed at solving practical legal problems.5 Academic legal research is related to efforts to provide valuable contributions to the development of legal science through the discovery of new legal theories, or finding new arguments, or finding new concepts regarding matters that are considered to be established in legal science.6
The approach used in this research is the legal regulatory approach (statute approach), and conceptual approach (conceptual approach).
2.2 Legal Materials.
The legal materials required in this research are primary and secondary legal materials.
2.3Procedures for Collecting and Analyzing Legal Materials.
The research was conducted in 2 (two) stages, namely the collection of legal materials (legal materials) and review and/or analysis of legal materials. The collection of legal materials is carried out through a positive legal inventory and literature search (literature study) related to the problem being researched.
All legal materials that have been collected are then organized and classified according to the problem formulation, research objectives, and the systematics of compiling research results. After all legal materials are organized and classified, analysis and/or interpretation are carried out. Through this method, it is hoped that the problems in this research can be studied and solved.anhis.
- RESULTS AND DISCUSSION
- CHARACTERISTICS OF TELEMEDICINE IN MEDICAL PRACTICE
- Understanding Telemedicine
In general, telemedicine is the use of information and communication technology combined with medical expertise to provide healthcare services, from consultations and diagnoses to medical procedures, without the constraints of space or remotely. To function effectively, this system requires communication technology that allows for the interactive transfer of data in the form of video, sound, and images. real-time by integrating it into supporting technology video conference. Included as supporting technology for telemedicine is image processing technology for analyzing medical images.7
The goal of telemedicine is to achieve equitable healthcare across the country's population, improve service quality, especially in remote areas, and reduce costs compared to conventional methods. Telemedicine also aims to reduce referrals to doctors or healthcare services in large cities, medical education facilities, and emergency cases. Telemedicine's benefits could extend to disaster areas, long-haul flights, and international tourists in tourist destinations.8 The same opinion was also expressed by Soegijardjo Soegijoko, that telemedicine is the use of information and communication technology including electronics, tele-communication, computers, informatics to transfer (send and/or receive) medical information, in order to improve clinical services (diagnosis and therapy) and education. The word "tele" in Greek means: far, at a distance, so telemedicine can be interpreted as medical services, even though separated by distance.9
- Telemedicine Practice Types
The use of telemedicine is highly dependent on the type of telemedicine practice. The type or form of telemedicine practice can be tteleconsultation, teleassistance, teleeducation and telemonitoring as well as telesurgery.10
Supported by medical equipment that can convert video images into digital images, now, the use of telemedicine in medical practice has been widely used. Until now Telemedicine has been applied in many countries in the world such as America, Greece, Israel, Jepang, Italy, Denmark, Dutch, Norway, Jordan, Indiaand Malaysia.
- Types of Telemedicine
The types of telemedicine in their implementation are applied in two concepts, namely: real time (synchronous) and store-and-forword (asynchronous). Telemedicine in real-time (synchronous Telemedicine can be as simple as using a telephone or as more complex as using a surgical robot.synchronous Telemedicine requires the presence of both parties at the same time, for this reason a liaison medium is needed between the two parties that can offer interaction real-time so that one party can carry out health care. Another form in Ssynchronous Telemedicine is the use of medical equipment connected to a computer to allow interactive health checkups. Examples of the use of this technology include: Ph-otoscope which provides a facility for a doctor to look into a patient's hearing from a 'remote' distance. Another example is tele-stethoscope which allows a doctor to listen to a patient's heartbeat remotely.11
Telemedicine with store-and-forward (atsynchronous telemedicine) involves collecting medical data and sending this data to a doctor (specialist) at the right time for evaluation in a timely manner offline. This type of telemedicine does not require the presence of both parties at the same time. Dermatologists, radiologists, and pathologists are the specialists who usually use it asynchronous This telemedicine. Medical records in the proper structure should be a component of this transfer.12
- PRINCIPLES OF USING TELEMEDICINE IN MEDICAL PRACTICE IN INDONESIA
- Principles of Utilization of Information and Communication Technology (ICT).
The Indonesian government through the Ministry of Health has designed the National Health Information System Network (SIKNAS).13 This network is a virtual connection/network of electronic health information systems managed by the Ministry of Health and can only be accessed once connected. The SIKNAS network is an integrated data communications network infrastructure using Wide Area Network (WAN), a telecommunications network that covers a wide area and is used to send data long distances between Local Area Network (LAN) and other local area network architectures. However, this network is still limited to collecting health data for health statistics purposes and has not been specifically designed for clinical services in its function as telemedicine. Therefore, it still functions as a health administration service (e-health). Meanwhile, for development e-health especially telemedicine is still needed master patient indexso that data can be transacted, and will be collected from health facilities. Once this electronic health information system is fully functional, it is hoped that it will fulfill the principle of public benefit.
- Principles of State and Community Responsibility
Doctors, as practitioners of medical practice, are authorized to practice medicine based on a permit granted by the government. This permit represents the state's responsibility to regulate and foster medical practice in Indonesia.
Medical practice using telemedicine carries potential vulnerabilities that could lead to shifts in orientation, both in values and thinking, due to the influence of political, economic, social, cultural, defense and security factors, as well as science and technology. These shifts in orientation will impact the process of implementing health development.14 Moreover, so far, there have been no licensing regulations specifically for healthcare facilities using telemedicine, either by the government or local governments. Similarly, there are no provisions regarding accreditation.
This type of healthcare facility cannot be compared to a regular healthcare facility. Therefore, the certificates or licenses required are also different. This distinction requires different legal regulations. Therefore, it is necessary to establish national standards and guidelines for the use of telemedicine to ensure responsible, safe, high-quality, equitable, and non-discriminatory healthcare delivery. This is a shared responsibility between the government, healthcare practitioners, and the community.
- Principles of Competence, Integrity, and Quality
Given that telemedicine requires specialized skills and expertise, healthcare workers need to be equipped with specialized knowledge and skills in the field. Healthcare workers' mastery of minimum quality standards must be demonstrated through a credible certification system.
Professional standards are limits of ability (knowledge, skills and professional attitude) the minimum that must be mastered by an individual to be able to carry out professional activities in society independently, which is made by a professional organization. Likewise for medical services using Telemedicine, can only be done if the right to use it has been legally confirmed and there is no doubt about the professionalism of the practitioner. In Indonesia, so far, medical professional organizations have not specifically regulated professional standards for the use of telemedicine. Therefore, measurable professional standards must be part of the legal principles for the use of telemedicine by both Indonesian and foreign doctors.
- Principle Kequality, Good Faith, Kindependence, and Kvolunteerism and Legal Certainty
If a healthcare facility operating overseas, acting as a telemedicine provider, wishes to open its virtual network to reach patients in Indonesia, then establishing such cooperation requires provisions governing specific collaboration between the two countries, based on the principles of equality, good faith, and mutual respect. To facilitate such cooperation, it is best to conduct it with a country that already has diplomatic relations with Indonesia. Likewise, the cooperation between healthcare facilities in both countries must be based on sound operational technicalities and accountability to the public/patients.
As with the traditional doctor-patient relationship, the doctor-patient relationship using telemedicine must also meet the requirements stipulated in Law Number 29 of 2004 concerning Medical Practice. Article 39 states that medical practice is carried out based on an agreement based on a relationship of trust between the doctor or dentist and the patient in efforts to maintain health, prevent disease, improve health, treat disease and restore health. The agreement referred to represents the maximum effort of dedication of the medical profession that must be carried out by doctors and dentists in healing and restoring the health of patients in accordance with service standards, professional standards, standard operational procedures and the patient's medical needs.
Likewise, the form of cooperation between hospitals in Indonesia and health service facilities abroad that wish to collaborate using telemedicine networks must be based on the principles of equality and good faith.
- Data Security and Confidentiality Principles and Standardization
Everyone has the right to confidentiality regarding their personal health condition that has been disclosed to health service providers (Article 57 paragraph (1) of Law No. 36 of 2009 concerning Health). In the use of telemedicine, the protection of patients' privacy rights regarding their health data that is recorded electronically at health service facilities needs to be regulated so that it is not easily accessed by unauthorized parties. For this reason, it must be carried out by authorized officers who have special permission for this.
The guarantee of confidentiality of the patient's medical data is stated in the form of a written agreement with the patient, so that it can have legal implications if it is misused.
Every Electronic System Provider must organize the electronic system reliably and safely and be responsible for the proper operation of the electronic system (Article 15 paragraph (1) of Law Number 11 of 2008 concerning Electronic Information and Transactions). Guarantees of the security and reliability of the electronic system in telemedicine practice need to be carried out by a legal entity or competent institution that has received national and international recognition.
- The Principle of Patient Autonomy and Freedom to Choose Technology or Technology Neutrality.
Every patient has the right to accept or reject some or all of the medical assistance that will be given to him after receiving and understanding complete information about the action (Article 56 paragraph (1) of Law No. 36 of 2009 concerning Health).Patients also have the freedom to choose technology or be technology-neutral after being informed about the benefits and risks of using said technology. This ensures that any decision made by the patient can provide a sense of security, fairness, and legal certainty.
- Principles of Patient's best interests first, Data Protection, IT Forensics, Best Practices (best practices), and Legal Examination Standards (Legal Audit) and Justice.
If a dispute arises, any person can file a lawsuit against the party that organizes the Electronic System and/or uses the Information Technology that causes the loss (Article 38 paragraph (1) of Law Number 11 of 2008 concerning Electronic Information and Transactions)
In the process of proving evidence in court, patient medical data is crucial for its use as evidence. Therefore, healthcare services using telemedicine must adhere to data protection regulations so that it can be used as evidence if needed in the future. Furthermore, IT forensics experts must be available. computer forensics is a derivative discipline that studies computer security and discusses the discovery of digital evidence after an event occurs.
According to Edmon Makarim,15 best practice principle (best practices) is a very important issue and is frequently raised by technologists, especially when an information and/or communication system interacts with the public interest. This principle represents the legal responsibility of electronic system administrators regarding the accountability of the electronic systems they create. Therefore, good governance based on the perspective of telematics legal convergence is needed.
Resistance or release from responsibility can only occur if the organizer can prove that the error occurred not because of him but because of force majeure. (force majeure) or it may actually occur due to user error and/or negligence on the part of the user of the electronic system itself. This can only be proven if a legal examination is first carried out (legal audit) regarding the implementation of the electronic system.
Objectives legal audit in general there is openness (disclosure) information where this is linked to the guarantee of validity (legalitas) related objects, in relation to third parties. With the existence of legal audit legal facts regarding electronic systems can be presented in their entirety without any material facts being covered up (full disclosure) so that investors or users (bondholders) guaranteed to obtain accurate information (not misleading).
In the dispute resolution mechanism, the parties have the authority to determine the court, arbitration, or other alternative dispute resolution institution authorized to handle any disputes that may arise. However, it is best to prioritize the interests of the injured party, in this case the patient, who must be prioritized. Therefore, to facilitate a smooth judicial process, the applicable law is the law of the patient's domicile. Otherwise, the dispute can be resolved based on the principles of international civil law.
The division of responsibility if a doctor is proven to have committed malpractice can be seen from two perspectives: the first is based on the extent of the doctor's error. In this sense, if the error lies with the specialist doctor who provided the advice, the doctor who implemented the advice should be held accountable for the error as much as possible. The second is based on which party received the greatest contribution from the payment received for services. Doctors who receive higher fees must also be willing to accept greater responsibility, including legal liability, in the event of malpractice.
- Principles of Legal Protection
Based on Law Number 11 of 2008, any person who commits a legal act as regulated in this Law, whether within the jurisdiction of Indonesia or outside the jurisdiction of Indonesia, which has legal consequences in the jurisdiction of Indonesia and/or outside the jurisdiction of Indonesia and is detrimental to the interests of Indonesia can be punished. So if a medical practitioner commits malpractice that causes harm to a patient in Indonesia even though it is done abroad, he can be punished under this law.
- CONCLUSION AND SUGGESTIONS
- Conclusion
- Indonesia's geographical conditions as an archipelagic country provide unique challenges in health development because apart from causing... high cost In infrastructure development, we are also faced with various health problems that are identical to the problems of developing countries, so a special approach is needed in health development in Indonesia according to its characteristics.
- Telemedicine applications can be a solution to address health issues in Indonesia. Consequently, regulatory development is absolutely necessary to address the legal issues.
- The legal issue of using telemedicine in medical practice is licensing, accreditation, privacy and confidentiality of patient electronic medical records, SOPs, liability in the event of malpractice, and jurisdictional authority,
- The principles and rules for the use of telemedicine in medical practice are: ease of access, state responsibility, competence, integrity, and quality, good faith, data security and confidentiality, standardization, patient autonomy and freedom to choose technology or technology neutrality, benefits, justice, humanity, balance, legal protection,
- The resolution of telemedicine disputes over alleged medical malpractice is based on the legal principle that the applicable law is the law of the patient's domicile, as the patient's interests as the injured party must be prioritized. In terms of proof, the principles of data protection, IT forensic principles, and best practice principles apply.best practices), and Legal Examination Standards (Legal Audit), and justice
- Saran
- Laws regarding the use of telemedicine need to be made specifically because legal norms in various existing regulations cannot regulate and follow developments in legal issues.
- The creation of regulations on telemedicine needs to pay attention to the legal principles of telemedicine while still paying attention to religious and social values in society.
- Essentially, with adequate counseling or information from a doctor, patients or their families can evaluate every step the doctor takes. Iinformed consent (consent to medical treatment) important to noteand important to be provided by the doctor and understood properlyuhnya by the patient/family so that there is no disappointment from the results of medical services by using telemedicine become a malpractice case.
- Considering that medical practice using telemedicine can involve doctors and patients of different nationalities, it is necessary and crucial to first understand the applicable legal system, cultural, social and economic background, and local language.
- While telemedicine offers numerous benefits, its use must be considered wisely, as the use of technology can reinforce a mechanistic paradigm and an instrumental approach to the human body. This can lead to the manipulation of humans as tools and interests beyond medicine. Therefore, the therapeutic relationship between doctor and patient in telemedicine must be grounded in the noble values of medical philosophy, which views humans as noble beings. Spirituality and spiritual health are expected to be part of the development of telemedicine in medical practice.
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