Law and digitalization of modern healthcare

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Introduction The rapid advancement of digital technologies has led to extensive transformations of the key aspects of human life. Information and communication technologies (ICT) that specify modern interpersonal communication are at the core of all interactions. As indicated in various regulatory documents, digitalization of healthcare is among the legal policy priorities of the Russian Federation. Therefore, the Presidential Council for Strategic Development and National Projects approved the Passport for the priority project of October 25, 2016, Protocol No. 9 On Improving the Processes of Organizing Medical Care Based on the Introduction of Information Technologies. Subsequently, the Passport for the Healthcare national project was supplemented by the federal project of December 24, 2018, Protocol No. 16 On Creation of a Unified Digital Circuit in Healthcare Based on the Unified State Health Information System (USHIS). The establishment of a unified digital circuit is among the key objectives of the Strategy for Healthcare Development in the Russian Federation until 2025, approved by the Presidential Decree of the Russian Federation No. 254 of June 06, 2019, and the Strategic Direction of Digital Transformation of Healthcare No. 3980-r, approved by the Government of the Russian Federation on December 29, 2021. Additionally, the Ministry of Health of the Russian Federation and the Federal Service for Supervision of Healthcare in the Russian Federation have approved various departmental digital transformation programs within the Digital Public Administration federal project of the Digital Economy of the Russian Federation national program. Digital technologies play a significant role in establishing horizontal connections, providing real-time information and services, thereby accelerating social processes and opening up new avenues for the advancement of P4 medicine[101]. In the Russian Federation, this holistic approach to healthcare is known as “personalized medicine”. The Concept of Predictive, Preventive and Personalized Medicine, endorsed by the Order of the Ministry of Health of Russia No. 186 of April 24, 2018, aims to enhance a patient-oriented healthcare. Therefore, digitalization can provide a technological foundation for personalized medicine. The digital transformation also brings profound changes to the public health sector. Rapid and intelligent processing of large amounts of data enables better allocation of financial resources, aids in predicting public health promotion, disease prevention, and development of healthcare logistics. As data accumulates, it is crucial for the government to adhere to principles of transparency that underpin the concept of open data[102]. Legal aspects of electronic health and electronic medical record The integration of computers into the healthcare system has rapidly led to process automation, and the development of healthcare informatics. Concurrently, the use of telecommunication technologies for transmitting information gave rise to the concept of telemedicine in the early 1990s. Various models for data transfer were explored, uncovering persistent challenges that remain relevant today: ensuring patient data protection (Margolis, 1994:14), maintaining the reliability of consultations (Sanders & Bashshur, 1995:118), and establishing clear responsibilities for all participants in the consultations (Brahams, 1995:199). Telemedicine, critical in current times, has dramatically expanded its potential through diverse methods of real-time data exchange. It acts as a digital aid in revolutionizing access to healthcare. However, Russian legislation has struggled to keep pace with the advancements in telemedicine. The Concept for the Development of Telemedicine Technologies in the Russian Federation and its Implementation Plan were approved by the Ministry of Health and the Russian Academy of Medical Sciences on August 27, 2001, under Order No. 344/76. Despite this, tangible legal frameworks failed to gain support from the State Duma of the Federal Assembly of the Russian Federation. The Draft Federal Law No. 308883-4 On Information and Communication Technologies in Medicine was officially introduced by some deputies in 2006, but was not considered until its exclusion in 2011. This issue was brought to attention following the President’s message in 2016, which promptly led to the adoption of the Federal Law No. 242-FZ of July 29, 2017 On Amendments to Certain Legislative Acts of the Russian Federation on Application of Information Technologies in the Sphere of Healthcare. Subsequently, the Procedure for Organizing and Providing Medical Care Using Telemedicine Technologies was approved by the Ministry of Health on November 30, 2017, under Order No. 965n. The advancement of Information and Communication Technologies (ICT) has led to the concept of “electronic health” (e-health), introduced by John Mitchell who is widely credited with establishing this term, marking a transition from telemedicine. He defined e-health as a new term needed to describe “the combined use of electronic communication and information technology in the health sector for clinical, educational, research and administrative purposes, both at the local site and at a distance” (Mitchell, 1999:55). The term gained popularity, especially after Intel Corporation (Santa Clara, California, USA) described e-health as “a concerted effort undertaken by leaders in health care and hi-tech industries to fully harness the benefits available through convergence of the Internet and health care”. Gunther Eysenbach further elaborated on e-health as “an emerging field in the intersection of medical informatics, public health and business, referring to health services and information delivered or enhanced through the Internet and related technologies. In a broader sense, the term characterizes not only a technical development, but also a state-of-mind, a way of thinking, an attitude, and a commitment for networked, global thinking, to improve health care locally, regionally, and worldwide by using information and communication technology. As such, the “e” in e-health does not only stand for “electronic”, but implies a number of other “e’s”, which together perhaps best characterize what e-health is all about”. The 10 e’s in “e-health” represents various aspects such as efficiency, quality enhancement, evidence based practices, empowerment, encouragement, education, information exchange facilitation, expanding healthcare reach, ethics, and equity (Eysenbach, 2001). While the definitions by J. Mitchell and G. Eysenbach are commonly used in encyclopedias and basic publications on e-health, there are still variations in understanding the concept. Given holistic understanding of e-health and the conventional terminology, the lingering conceptual “discrepancy” distinguishes three major concepts: - e-health as healthcare based on innovative technologies; - e-health as a set of technological capabilities and infrastructure applied to deliver healthcare services; - e-health as a service sector and component of the commercial sector (e-commerce) to maximize profits. Given such perceptual diversity of the term, the legal approaches or, more accurately, the goals to be set in forming the legal framework would need to be adjusted. If the objective is healthcare regulation, then the focus should be on healthcare providers and patients; if the objective is technology, then the interests of hardware and software developers take precedence; if the objective is the market sector, then commercial interests are crucial. Apparently, the government should address all aspects, while ensuring the protection of patient-physician interests. The implementation of an electronic medical record (EMR) is a key guideline for the development of e-health both in Russia and internationally. As for the Russian Federation, the EMR sparked significant debate while developing the Concept for the Development of the Healthcare System in the Russian Federation until 2020 in the 2010s. A.A. Mokhov was among the first legal scholars to interpret the EMR term as “a document that contains personal information about the patient, requests for medical assistance, services provided, therapy performed, invasive interventions, vaccinations administered, and other life characteristics (developmental anomalies, injuries sustained, allergic reactions, etc.)” (Mokhov, 2010:23). While the electronic medical record (EMR) remains relevant, its adoption is not widespread in the country, except for the advanced model implemented in Moscow[103]. This platform is supplied with a remote server to systematize data (limited to Moscow) and a mobile app to track real-time information. In 2009, a unified portal of state and municipal services commonly referred to as Gosuslugi was established, featuring a Health profile component. This digital platform, operated by the Russian government, functions as a federal information system and is accessed through an informational block rather than a personalized specialized card. Users can input data into their personal profiles on this shared resource. Legal development took place in 2017 when the innovation was launched with the Federal Law No. 242-FZ of July 29, 2017 (previously mentioned in connection with telemedicine). This was followed by the adoption of the Government of the Russian Federation’s Order No. 2521-r of November 15, 2017, which approved the List of Healthcare Services that can be provided to citizens in electronic form through the unified portal of state and municipal services by the unified state information system in the field of healthcare. The legal foundation for electronic medical records (EMR) can be found in the Federal Law No. 326-FZ of November 29, 2010, On Mandatory Medical Insurance in the Russian Federation, which provides funding for maintaining patient medical records in electronic form (Article 50, Part 3, Clause 2). Subsequently, the Ministry of Health of Russia approved the Main Sections of the Electronic Medical Record through its Order No. 18-1/1010 of November 11, 2013, in alignment with the aforementioned law. This framework specifies the EMR as “a set of electronic personal health records (ePHR) related to an individual patient to be collected, stored, and used within a single healthcare organization”. Despite allowing for the creation of multiple EMR for patients seeking help from various medical organizations, the current system lacks a mechanism for patients to provide feedback or make any alterations to their own records. The Order of the Ministry of Health of Russia No. 834n of December 15, 2014, On Approval of Unified Forms of Medical Documentation Used in Medical Organizations Providing Outpatient Medical Care, included several documents, with the outpatient medical record (form No. 025/u) being one of them. The Order of the Ministry of Health of Russia No. 2n of January 09, 2018, On Amendments to the Order of the Ministry of Health of the Russian Federation No. 834n of December 15, 2014, specified that the outpatient medical record should be generated in electronic form (Clause 2.1). The Order of the Ministry of Health of Russia No. 947n of September 07, 2020, On Approval of the Procedure for Organizing a Document Management System in Health Protection in Regard to Maintaining Medical Documentation in the Form of Electronic Documents, came into force to regulate medical electronic document management. It should be noted that specialized medical organizations maintain their own patient medical records for various specialties such as oncology, phthisiology, psychiatry, psychiatry and narcology, dermatology, dentistry, and orthodontics. The long-term work plan of the Federal Fund for Mandatory Medical Insurance (FFMMI) for 2023[104] featured the initiation of activities related to a digital patient profile to monitor the quality of medical care and ensure proper distribution of the FFMMI finances. The Unified State Health Information System (USHIS) serves as a technological platform within the legal framework determined by the Governmental Decree No. 140 of February 09, 2022, On the Unified State Information System in the Field of Healthcare. The Unified State Health Information System (USHIS) is designed to encompass a wide range of medical data and administrative functions, including patient registers, dispensary registration certificates, medical care accounting catalogs, healthcare organization and medical worker registers, statistical observation records and various analytical tables. The system is also anticipated to facilitate the transfer of medical records (such as MRI and CT scans) and to serve as a platform for certain telemedicine functions. Additionally, the platform is expected to connect various electronic healthcare stakeholders, including patients, healthcare organizations, medical professionals, healthcare authorities, and players in the pharmaceutical market (both wholesale and retail), creating a comprehensive system for information exchange covering public and personal health aspects. The significant data volume of the USHIS must be forecasted to ensure effective management and utilization. Despite the forward-looking nature of this “super service”, its current usage appears to be limited. Many aspects remain unregulated by law, hindering the accumulation and utilization of data. For instance, the legal framework for data management has not been fully established, as highlighted by the Federal Law No. 126-FZ of April 30, 2021, which outlined the registration of electronic sick leave certificates via the Gosuslugi platform with minimal patient involvement. It is evident that while certain activities, such as obtaining a sick leave certificate, can be completed through Gosuslugi, other interactions with non-governmental healthcare providers, involving the management of personal medical data, are not currently integrated into the platform. Furthermore, the regional expansion of Electronic Medical Records (EMR) by the constituent entities of the Russian Federation, along with the development of a regional portal for medical services, represents another technological advancement in the healthcare sector. An analysis of the European practices has revealed that the adoption of special legislation governing electronic medical records (EMR) for patients is uncommon. One notable example is the Federal Act on Electronic Patient Records, which was implemented in Switzerland on June 19, 2015 and officially came into force on April 15, 2017[105]. According to Article 2 of this act, an electronic patient record (EPR) is described as a “virtual dossier that allows decentralized storage of treatment-relevant data from a patient’s medical history or their personal recorded data, which can be accessed during specific treatment cases”. In a session on June 28, 2023, the Federal Council proposed a corresponding revision of the Federal Act on the Electronic Patient Record for consultation. Under a proposed revision, a free EPR will be automatically created for all individuals residing in Switzerland with mandatory health or military insurance. Each individual will have the authority to determine which healthcare professionals have access to their EPR. Additionally, individuals who do not wish to have an EPR can submit an objection to prevent its creation. This opt-out model aims to promote wider dissemination and use of EPR, positioning them as a central component of the healthcare system. Moreover, the medical data stored in EPRs hold significant value for researchers. The proposed revision of the Act would also allow individuals with an EPR to explicitly consent to making non-anonymized medical data from their EPR available for research purposes. In order to access the EPR, there are plans to introduce a future national electronic identification (e-ID) interoperable with digital certificates for citizens. European Union (EU) member states operate under overarching regulations for personal data processing, with specific emphasis on the confidentiality and sensitivity of medical data. As such, Electronic Records (EPR) is subject to the General Data Protection Regulation (GDPR)[106] within the EU member states. While the stringent restrictions enforced by the GDPR aim to safeguard privacy, they have faced criticism from healthcare professionals who argue that strict compliance impedes the collection of crucial data necessary for advancing public health initiatives. Evert-Ben van Veen has highlighted the incompatibility of social networking concepts with the secure management of medical record banks (Van Veen, 2018:70-80). Concerns have also been raised by academics, such as Williams (Williams, 2018:508) and Staunton, Slokenberga, and Mascalzoni (Staunton, Slokenberga & Mascalzoni, 2019), regarding GDPR requirements that could significantly impede medical data research. In 2019, the European Commission adopted the Recommendation on a European Electronic Health Record Exchange Format[107] to facilitate the interconnectivity of Electronic Health Records (EHR) across EU borders. This initiative aims to assist EU countries in their efforts to ensure that citizens can securely access and exchange their health data throughout the EU. Despite the advancements made and the allocation of financial resources, there are persistent challenges that hinder the seamless integration of unified information systems, exemplified by the regulatory obstacles between Finland and Estonia[108]. The widespread EHR adoption offers numerous benefits, but its successful implementation and acceptance hinge on effectively mitigating the associated privacy and security risks (Kierkegaard, 2011). Some scholars highlight the retention of bulk data as an example of modern state surveillance (Birrer, He & Just, 2023). Given the sensitive nature of health data, individuals consulting healthcare professionals inherently expect a level of confidentiality that originally emerged as a social construct to foster trust in medical practitioners. However, with the current level of digitalization, the concept of confidentiality has evolved into more technocratic forms of data protection, akin to a ‘zombie category’ that persists its changing meaning (Wadmann, Hartlev & Hoeyer, 2023). The global trend towards universalization is facilitated by the adoption of the unified standard set by the International Organization for Standardization (ISO), specifically ISO 10781:2023 Health Informatics - HL7 Electronic Health Record-System Functional Model, Release 2.1 (EHR FM)[109]. While the pursuit of universality requires significant technological efforts rather than jurisprudential considerations, several key features warrant attention: · Technical regulations often take precedence over legal norms in various domains. · Interaction models and data transfer protocols may differ, and adopting a unified approach may not always align with such constitutional values such as security and confidentiality. · Achieving e-health objectives depends on technological independence, as lacking proprietary technological solutions may lead to dependence on foreign entities within a country’s population. · The development of technological capabilities must be coupled with the cultivation of specialized skills and competencies among healthcare professionals and patients to effectively leverage modern digital opportunities. When designing the national legal framework for the EMR, it is essential to consider each of the aforementioned aspects. Legal aspects of mobile health The advancement of multi-purpose mobile phones (smartphones) and messaging platforms for real-time information exchange has transformed the fundamentals of interpersonal communication, consequently affecting healthcare. This shift has been amplified by the proliferation of diverse gadgets that enable individuals to independently monitor personal health metrics, gather health data, and access a range of personalized assistance. An array of portable tech devices is now available from pharmaceutical companies, including tonometers, glucometers, pulse oximeters, multi-function cholesterol meters, blood uric acid meters, and drug delivery systems. Additionally, portable and wearable ultrasonic system-on-patch (USoP) devices have been developed for applications like early-stage breast cancer detection (Burgess, Gluskin & Pinker, 2023:1948) and monitoring deep tissues in moving subjects (Lin, Zhang & Gao, et al., 2023), etc. Smart watches, a modern accessory widely used in everyday life, offer functionalities such as tracking the number of steps taken, monitoring cardiovascular fitness and blood oxygen levels, measuring heart rate, heart rhythm, body temperature, and blood pressure. There are publications highlighting the use of smart watches for diagnosing cardiovascular conditions and preventing myocardial infarctions (Drexler et al, 2020:2224). The advancement of such devices generates vast amounts of data, previously only collected through direct contact with healthcare organizations. Nowadays, the role of the patient as an active partner in health care, rather than just a passive subject of diagnostic tests and medical treatments, is widely recognized. The emergence of various applications has enhanced healthcare engagement for individuals, promoting participation in personalized medicine systems. We highlight the most popular apps known for their functionality and capabilities in simplifying the doctor-patient relationship. Specialized apps popular amongst pregnant women to maintain pregnancy journals, store ultrasound scans, track doctor appointments, etc. Applications are actively developed and used for various purposes, including: 1) promoting a healthy lifestyle with physical activities, and nutrition monitoring; 2) managing chronic conditions like diabetes mellitus, bronchial asthma, and mental disorders; 3) medication reminders; 4) a rehabilitation comorbid with acceptance and commitment therapy (Kim, et al, 2021). Moreover, various applications are being created for doctors to expedite searches for specialized literature and medication guidelines. Patients have access to apps integrating cloud storage for medical test results, digital assistants for healthy eating, disease-predicting chatbots, and services enabling remote communication between patients and healthcare providers or family doctors. Consequently, connected health technology is evolving, establishing an entire ecosystem (medical organization - doctor - patient) as a component of public health (Carroll, Kennedy & Richardson, 2016:67). It is important to note that the accessibility of various devices raises concerns about their compatibility and the potential for systematizing data collected from diverse sources. Large-scale distribution of assorted gadgets has led to the emergence of a specific field known as mobile health (mHealth). Affordable wireless mobile devices and applications, increasingly accessible, have become widely used. Unlike traditional e-health that primarily focuses on static elements such as telemedicine and patient records, mHealth centers on dynamic aspects like symptom tracking, physical status monitoring, medication reminders, personalized support for chronic illnesses, and immediate access to health-related information (Stecher, et al, 2023). Amid the COVID-19 pandemic, the delivery and access to health care have faced unique challenges, particularly during lockdowns. Physicians have had to provide healthcare services remotely and have embraced mHealth due to physical distancing restrictions. Additionally, mHealth apps utilize location data and proximity alerts to notify users if they have been in close contact with someone who later tested positive for COVID-19. These timely alerts empower individuals to self-isolate, seek testing, and inform their healthcare providers, contributing to breaking the chain of transmission. This technology also offers healthcare professionals the opportunity to remotely consult and share data with colleagues. Furthermore, mHealth not only enables patients to receive remote consultations but also enhances medication adherence and delivers disease education (Alsahli, Hor & Lam, 2023). The “quiet” revolution that has evidenced digital transformation to be more than just a technological shift also influences both strategy and management tactics in the healthcare sector, necessitating adequate legal support (Angerer, Stahl, Krasniqi & Banning, 2022). It is vital to legally consolidate a digital doctor-patient communication since these relations involve key issues of medical liability and legal assessment of medical errors. Moreover, the extensive involvement of nearly every aspect of private life including health status in the digital realm brings forth cyber-related threats and challenges. Integrating mHealth data into a single network enables personalized monitoring but also raises concerns about the security and privacy of such sensitive medical information. Various stakeholders such as insurance companies, banks, employers, etc., may seek access to this data. However, healthcare data breaches and cyber attacks have become increasingly prevalent. For example, Brno University Hospital in the Czech Republic fell victim to a recent ransomware attack through spear-phishing, resulting in the encryption of data across the entire hospital network. Other cyber attacks have targeted organizations such as the Hammersmith Medicines Research Group in the United Kingdom (a COVID-19 vaccine trial group), Paris Hospital Authority in France, Babylon Health (a hospital appointment and teleconsultation videoconferencing system) in the United Kingdom (Muthuppalaniappan & Stevenson, 2021). In each of these cases, the operations of medical organizations were disrupted for some time, and additional resources were needed to restore records and electronic systems. Data breaches and security issues in healthcare have significant implications for confidentiality, integrity, and availability. The aftermath of cyber attacks on healthcare organizations includes a loss of trust, credibility, and confidence from stakeholders. Furthermore, these organizations may face financial impacts and regulatory sanctions if proper care and processes were not followed. Healthcare disruptions due to cyber attacks can also undermine a nation’s overall healthcare policy, as the unavailability of healthcare systems could compromise citizens’ right to health care. While the introduction of various medical portable devices allows for remote information transmission (usually via Bluetooth) and leverages the Internet of Things (IoT), it also introduces cyber security risks, such as remote program hacking and device reconfiguration. The IoT involves similar elevated risks due to data transfer within a network of interconnected devices exchanging data. Specific mobile apps have been developed for use on small, wireless computing devices, such as smartphones. For example, medical/vital monitors designed for healthcare use on the body provide a precise real time tracking. The management systems and internal logistics within modern hospital institutions are increasingly built on the IoT-based technology (Haidhar Athir Mohd Puat & Nor Azlina Abd Rahman, 2020). However, this management model becomes susceptible to external influence, posing threats to both specific medical organizations and the entire healthcare system. Legal aspects of digital health Digital health is a broad concept that includes electronic health, mobile health, healthcare informatics, and other digital tools that contribute to the advancement of a wide range of healthcare services and public health. An analysis of international law has revealed several initiatives aimed at regulating digital health applications. For instance, the General Digital Health Law, which regulates digital health applications, was presented in Mexico on December 15, 2023, marking the most ambitious draft initiative in the country. However, according to the International Comparative Legal Guides expert analysis, it is unlikely that major regulations regarding digital health will be passed due to numerous controversial issues[110]. In Germany, the Act on Secure Digital Communication and Applications in the Healthcare System (E-Health-Gesetz) of December 21, 2015[111] triggered a debate on digitization, data protection and health. Since then, the digitalization of the healthcare system has been promoted through various laws, including: · The Appointment Service and Healthcare Supply Act (TSVG) of May 6, 2019[112]; · The Act for More Safety in the Supply of Pharmaceuticals (GSAV) of August 9, 2019[113]; · The Act to Improve Healthcare Provision through Digitalization and Innovation (Digital Healthcare Act - DVG) of December 9, 2019[114]; · The Act for the Protection of Electronic Patient Data in the Telematics Infrastructure (Patient Data Protection Act - PDSG) of October 14, 2020[115]; · The Act on Digital Modernization of Healthcare and Nursing (DVPMG) of June 3, 2021[116]. The enacted laws have defined the system for electronic patient data, ensuring privacy protection guarantees; introduced legal incentives to hasten the adoption of medical electronic applications; established protective measures for IT structure development in German healthcare, introducing mandatory requirements for technological compatibility of various applications, databases, platforms, and services; included telemedicine in the list of services reimbursed by insurance organizations; implemented a mechanism to enhance digital literacy in healthcare and reinforce patient empowerment. The Russian legal policy could benefit from considering the German experience, given the national characteristics of public administration in the healthcare sector. The opportunities presented by digitalization can guide strategic planning across various regulatory sectors. The Presidential Council for Strategic Development and National Projects endorsed the Passport for the priority project Digital Economy of the Russian Federation on June 04, 2019, Protocol No. 7. Despite the existence of various project subprograms, there is currently no dedicated strategic document for digital health in Russia, unlike in other countries. Here is a summary of the main prospects of digital medicine and the challenges faced by modern legal regulation: 1. The use of big data in healthcare enables a significant shift in approaches to individual patient treatment. Data gathered from various electronic devices or entered into the digital sphere can be processed based on specified parameters. A defining characteristic of big data is that altering parameters leads to new outcomes, facilitating continuous work with big data to achieve desired results. Additionally, anonymizing big data ensures secure conditions for data subject. The rise of large datasets has underscored the need for a comprehensive legal framework for big data. In 2018, the Russian Federation introduced Draft Law No. 571124-7 On Amendments to the Federal Law on Information, Information Technologies, and Information Protection[117], which aimed to solidify the concept of “big user data” and determine the operator status for such data. However, the State Duma committee on Informational Policy, Technologies and Communications returned the draft for revision, and no further attempts were made to introduce the project to the country’s legislative body. 2. Big data serves as a foundation for artificial intelligence (AI), raising concerns about the involvement of healthcare professionals in the decision-making process. For instance, AI has been successfully employed in cancer risk prediction, risk factor identification, and differential diagnosis (Yang et al, 2022). It is important to distinguish between weak AI and strong AI. The former is viewed as a tool that assists doctors in problem-solving through technical devices, programs, and algorithms, enabling them to independently diagnose diseases and provide medical care without the need for fundamental changes in legislation. Strong AI involves the concept of a “digital doctor” - a mechanism capable of performing certain functions of a physician or replacing them entirely. However, the lack of uniform regulatory approaches has resulted in the lack of legislation in most countries worldwide. Nonetheless, a range of complex legal issues must be addressed in the nearest future, including intellectual property rights related to improved machine learning algorithm (where both programmers and doctors may be involved in the algorithm description), medical malpractice liability, and delineation of responsibilities between a physician and a digital doctor. The integration of AI-powered clinical decision support systems and personal assistants in the treatment of various diseases, such as stroke, diabetes, and cancer, has revolutionized the processing of extensive patient data. For instance, a clinical decision support systems for monitoring cancer tumors rely on access to liquid biopsies and their digital representation. Within the healthcare sector, there is an imminent need to effectively manage global data to promote the cross-border exchange of significant healthcare information. Nonetheless, this initiative presents complex legal challenges. Notably, the Government of the Russian Federation has approved the Rules for Import and Export of Biological Materials Obtained in Clinical Trials of Medicinal Products for Medical Use into and from the Russian Federation[118]. The increasing utilization of AI in healthcare has paved the way for advancements in related domains, such as: - Translational bioinformatics encompasses the comprehensive analysis of statistical data, genomic information, and clinical records to bolster healthcare quality, accessibility, and efficiency. However, it is essential to address the absence of legislative frameworks concerning genomic techniques, particularly pertaining to human deoxyribonucleic acid (DNA) within the Russian Federation. - Digital health information management plays a crucial role in strengthening internal processes within any healthcare organization. The concept of Digital Hospital has emerged to address numerous management challenges, including the medical personnel mobility. - Virtual reality, augmented reality, and the metaverse have been increasingly integrated, with computer simulations being widely introduced (Bakshi et al, 2021:1326), gamification in healthcare management, and virtual sensory tests for patients with muscle fatigue[119], among other applications. However, these technologies lack a specific legal framework within the Russian Federation. 3. Digital biomedicine involves various digital products and techniques, such as organ-on-a-chip technology (Driver & Mishra, 2023), virtual health assistants (Curtis, et al, 2021), bioprinting (Romanovskaya & Romanovskiy, 2023), brain-computer interfaces (BCI)[120], and digital biomedical devices like bionic prostheses[121]. However, the implementation of these advancements presents complex ethical challenges that necessitate a reassessment of fundamental human rights. For instance, the introduction of a brain-computer interface involves the insertion of small chips into the human brain to stimulate motor-related areas, unlike commonly used biomedical chips like microfluidic chips. The extensive use of such interfaces to enhance human intellectual capabilities and to blur the boundaries between the biological and digital realms gives rise to the concept of biodigital convergence (Peters, Jandrić & Hayes, 2021:377). This convergence describes the merging of biological and digital technologies, termed biodigital technologies, impacting both social and biological life by transforming it into a digital code. Bioprinting of organs, human tissues, and nerve cells is performed based on such digital code (Rad, et al, 2022). As these advancements progress, they are expected to encounter legal issues related to extending constitutional legal personality to models with intellectual abilities, addressing gene-based discrimination between individuals with innate and altered abilities, and defining boundaries for human rights such as the right to life, personal integrity, and privacy. Furthermore, companies have patented the creation of human digital virtual clones, replicating various social and psychological attributes of an individual[122]. AI technologies that promise more chatbots and replicas of deceased individuals transformed into a 3D shells have given rise to the concept of “digital immortality” (Hurtado, 2022). The concept of digital human rights that involves a biomedical aspect is currently a topic of active discussion. Conclusion The large-scale digitalization of healthcare has the potential to revolutionize the entire public health system and elevate personalized healthcare to new heights. However, the full potential of individual biological, social, and mental aspects within the healthcare system is yet to be fully realized. Personal data, in its broadest sense, is becoming increasingly vital for both the economy, in light of the digital revolution, and for healthcare, where it is gaining prominence as a public policy priority. The heightened individualization aimed at enhancing digital patient interaction not only expands individual capabilities, but also emphasizes personal health responsibility. The emergence of new opportunities to establish control not only over treatment processes but also over entire lifestyles is targeted at preventing and reducing the impact of many diseases. This shift may lead to a reevaluation of health protection responsibilities, transferring some health status aspects from personal to the public sphere. However, this also raises concerns about social control over sensitive areas of private life. The use of digital technologies to enhance healthcare provision stipulates various approaches to legal regulation. For instance, the adoption of new mobile applications will require amendments to Article 38 of the Federal Law No. 323-FZ of November 21, 2011 On Basics of Health Protection of the Citizens in the Russian Federation and the Nomenclature Classification of Medical Devices (approved by Order No. 4n of the Ministry of Health of Russia of June 6, 2012). Mere indication of the software used may not suffice for these documents; additional targeted changes, monitoring, and initiative from the Ministry of Health of Russia are required. Extensive work is also necessary to standardize technical requirements for the digitalization of the entire healthcare provision process, particularly in terms of a unified format for data input to ensure its usability for further processing. Given the global interest in processing healthcare big data, universalization should align with rules for cross-border data exchange. This comprehensive approach could help formulate more explicit recommendations for the organization of healthcare and the provision of healthcare services, considering different disease groups and patient classification. A number of digital health aspects involve organizational improvement through the implementation of the federal project Digital Public Administration of the national program Digital Economy of the Russian Federation. This will require management decisions, and its legal formalization should be as part of an overall administrative reform, thus redefining the role of the Ministry of Health as an architect of public administration. While digitalization brings about decentralization, it does not entail the abandonment of the system of government agencies; rather, it drastically alters their management methods, shifting from an imperative approach to the principles of behavioral economics, focusing on personal interests through nudging rather than direct coercion. Global trends such as brain chipping and introduction of EMR require careful ethical and legal consideration. Improving physician practice and enhancing patient convenience are primary objectives that involve addressing technical challenges to bring the entire information array to a “common denominator”. The Russian Federation has outlined the goal of creating USHIS as a global service to incorporate various resources and registers for multi-purpose data exchange. However, skeptics in countries with well-developed digital infrastructure doubt the feasibility of such unification. The integration of databases poses risks such as data breaches (theft), criminal cyber attacks, and violations by public authorities and healthcare professionals. The traditional provision of healthcare has long been based on trust through medical confidentiality, patient autonomy, and prioritizing patient interests. Disruptions to these fundamental principles may lead to patient uncertainly, information concealment, and a search for alternative healthcare, potentially leading to the emergence of fraudulent practices, facilitated by social networks. Addressing these challenges, such as ensuring patient familiarity with any access to their personal EMR and utilizing blockchain technologies for medical data storage, requires independent legal assessment. A major challenge arises from the emergence of biodigital convergence, wherein total digitalization risks reducing a human personality to a model with its own serial number. Additive technologies to bioprint human tissues and organs are based on converting them into numerical codes and transmitting them over distances. It is apparent that the aforementioned perspectives and similar ones call for an appropriate legal response, which is currently lacking in Russian legislation. The reforms proposed by the Ministry of Health of Russia face challenges in terms of burden and time required to pass them through the legislative process. Some laws are notably outdated, particularly those related to the legal regulation of genomic technologies, while others necessitate major revisions and supplements, such as the Federal Law No. 152-FZ On Personal Data of July 27, 2006 concerning big data and EMR regulations on Electronic Medical Records (EMR). Comprehensive reforms would involve overhauling the entire healthcare legislation, with a novel Healthcare Code of the Russian Federation as the ultimate objective. Implementing these measures would require addressing major existential dilemmas with an active legal support and lawyer participation.

About the authors

Olga V. Romanovskaya

Penza State University

Author for correspondence.
Email: pgu-gpd@yandex.ru
ORCID iD: 0000-0002-4563-1725
SPIN-code: 5496-7700
ResearcherId: C-7120-2017

Doctor of Law, Full Professor, Head of the Department of State and Legal Disciplines

40 Krasnaya str., Penza, 440026, Russian Federation

Georgy B. Romanovskiy

Penza State University

Email: vlad93@sura.ru
ORCID iD: 0000-0003-0546-2557
SPIN-code: 2791-8376
ResearcherId: S-7012-2016

Doctor of Law, Full Professor, Head of the Department of Criminal Law

40 Krasnaya str., Penza, 440026, Russian Federation

References