Digital Healthcare 2025 Comparisons

Digital healthcare technologies have become an integral part of modern medicine, whether in the prevention, diagnosis, treatment or management of health and diseases. These technologies include telehealth, telemedicine, mobile health, electronic medical records, remote patient monitoring, decision support systems and workflow management systems for the provision of healthcare services. Each form differs in its core functionalities and may be used in combination with other forms. Together, they contribute to the advancement and efficiency of healthcare systems.

Telehealth

Telehealth (and telemedicine) delivers remote clinical services. It encompasses a wide range of services that are provided remotely using digital platforms. In Israel, the health maintenance organisations offer patients the ability to consult with physicians online; these services are conducted through secure, dedicated mobile applications, due to privacy considerations. These services may include patient consultations through video calls, remote monitoring using handheld or wearable medical devices, and even the participation of experts in clinical procedures via virtual communication. Telehealth helps minimise the need for physical clinic visits and improves accessibility to care. For example, TytoHome is a home-use medical device that, when paired with a smartphone app and smart video call, allows doctors to remotely guide a live examination and provide diagnoses, treatment plans and prescriptions.

Telemedicine

Telemedicine is often considered a subset of telehealth, and refers more specifically to the remote delivery of clinical services by healthcare professionals. It allows physicians to monitor and examine patients using digital tools and provides a platform for diagnosis, treatment recommendations and follow-up care. Telemedicine supports real-time, doctor-patient interaction and is often used when direct examination is needed but cannot occur in person.

For example, Sheba Beyond, the Israel’s first virtual hospital, established by Sheba Medical Center, provides comprehensive remote medical care such as real-time consultations, diagnoses, treatment plans and prescriptions through secure video calls. The platform integrates advanced technologies, such as the Tyto device or Datos, a digital platform that enables continuous online monitoring and secure communication between patients and multidisciplinary care teams – including video calls, messaging, questionnaire responses and integration of health data from connected medical devices.

Mobile Health Technologies

Mobile health technologies focus on user engagement and lifestyle management. They are typically delivered through smartphone apps and wearable devices. These technologies promote preventative care and wellness by helping users track their physical activity, hydration, sleep patterns and other health indicators. Mobile health tools can also include AI-driven platforms that provide users or clinicians with insights or alerts based on individual health data and behavioural trends. For example, Sweetch is a mobile app that uses artificial intelligence to provide personalised health recommendations, motivating users to adopt healthier habits and prevent chronic conditions.

Electronic Medical Records

Electronic medical records serve as the digital infrastructure for clinical data. They are digital systems used to document and manage patients’ health information, including test results, treatment plans and medication histories. These systems enhance continuity of care by enabling the secure sharing of health data among providers and supporting decision-making with up-to-date information.

Remote Patient Monitoring

Remote patient monitoring enables healthcare providers to track patients’ health status from a distance through connected devices. This can include monitoring vital signs, such as heart rate or blood pressure, and transmitting data in real time to healthcare professionals. Remote patient monitoring supports chronic disease management and post-operative care, reducing the need for frequent in-person visits and allowing timely intervention when necessary. For example, Biobeat offers wearable medical-grade sensors that continuously monitor patients’ vital signs and transmit real-time data to healthcare providers, enabling early detection and timely intervention.

Digital technology is an integral part of Israel’s healthcare system and is widely adopted across all major health maintenance organisations, including Clalit, Maccabi, Meuhedet and Leumit. These health maintenance organisations are responsible for providing the majority of healthcare services in the country and have well-developed digital infrastructures.

One of the foundational elements of digital healthcare in Israel is the use of electronic medical records. The IT systems supporting electronic patient records are highly advanced and enable secure, comprehensive documentation and sharing of patients' health information across different care providers. These systems are not only used for direct care but also support population-level health monitoring and research, regulated through Ministry of Health circulars that govern privacy, data security and access.

Building on this digital infrastructure, Israel’s health maintenance organisations have widely implemented additional technologies such as telehealth, telemedicine, mobile health, data research projects and remote patient monitoring. Telemedicine services are common, including remote consultations via video and the use of handheld diagnostic tools such as TytoHome, a device provided by Clalit that includes diagnostic tools (eg, stethoscope, otoscope, thermometer) that can be used at home along with a smartphone app and smart video call, allowing doctors to remotely perform a live examination and provide a diagnosis, treatment notes and any referrals or prescriptions. The TytoHome kit allows for detailed health readings on critical areas of the body, such as the heart, lungs, ears, throat, abdomen and skin, as well as heart rate and body temperature.

Other examples of remote monitoring tools include SHL’s CardioSen’C, a portable device that monitors heart activity and can communicate the results instantaneously to a cardiologist. In addition, Maccabi has introduced KAI, an AI-powered psychological support assistant available 24/7 via WhatsApp, providing patients therapeutic support while awaiting professional care.

Mobile health platforms such as Clalit’s “Active” app promote lifestyle and wellness tracking, empowering patients to take a more proactive role in their health.

Digital healthcare offers significant advantages by improving patient outcomes, enhancing the work of healthcare professionals and contributing to cost efficiency. For patients, digital tools such as mobile apps, wearable devices and remote monitoring improve access to care, promote wellness and enable real-time tracking of health data. These technologies reduce the need for in-person visits and support early detection and preventative care.

For healthcare professionals, digital platforms enhance clinical decision-making through AI-driven decision support systems and big data analytics, and advanced imaging tools powered by computer vision. These technologies improve diagnostic accuracy, enable personalised treatment plans and streamline workflows by reducing administrative burdens and improving information sharing via electronic medical records. In recent years, computer vision has increasingly been applied to medical imaging and is now used in various clinical settings to support the interpretation of X-rays, CT scans, ultrasounds and other diagnostic images.

As outlined in the Israeli Ministry of Health's “Guide for Economic Evaluation of Digital Health Services” from March 2024, these technologies should also be assessed through a structured cost-effectiveness framework. The guide underscores that economic evaluation is essential for determining the true value of digital interventions and for ensuring efficient resource allocation in healthcare. It promotes the adoption of digital solutions that deliver measurable health benefits relative to their cost, helping decision makers prioritise investments that maximise both health outcomes and financial sustainability.

Digital healthcare also has the potential to lower healthcare costs by preventing hospitalisations, avoiding redundant tests and enabling more efficient resource use.

There are no regulatory definitions of digital health and digital medicine. There are several circulars of the Ministry of Health addressing certain aspects of these activities. The main body of regulation that is not health-specific but that applies to digital healthcare is the Israeli Privacy Protection Authority (PPA).

The digital transformation of the healthcare industry is unfolding rapidly, but the development of a comprehensive and detailed digital healthcare regulatory scheme is lagging behind. The government published a national digital transformation plan, and the Ministry of Health followed suit with its own digital health programme. However, the primary legislation was not amended.

As it stands, the main regulatory documents that have been published to date are circulars of the general manager of the Ministry of Health that concern:

• certain aspects of the secondary use and sharing of health data;
• the use of digital means in the process of obtaining informed consent;
• the use of cloud computing in the Israeli healthcare system;
• the criteria for operating telehealth medicine;
• providing patients accessibility to personal health data (“healthcare in the palm of your hand”);
• the protection of information in computerised systems in the healthcare system;
• the rules of ethics for remote care of the Israel Medical Association, etc.

The circulars are intended to be binding for health maintenance organisations and hospitals, although this is partially disputed by certain health maintenance organisations. Their authority over the private sector remains uncertain, yet considerable control over conduct is largely maintained due to the private sector’s reliance on healthcare institution data.

In early 2023, a draft bill proposing a health data portability law was introduced. The objective of this bill is to provide the necessary regulatory infrastructure to ensure that patient health information is available and reviewable when and where it is needed, all the while maintaining patient privacy and information security.

To realise the vision of quality information in the Israeli healthcare system and to facilitate and improve co-operation between the authorities, a medical nomenclature project was launched. This project promotes the use of documentation and data coding in the Israeli healthcare system, with the first phase involving the implementation of SNOMED-CT for uniform medical terminology to document medical operations and diagnoses.

At the data protection and privacy level, the PPA has published various publications covering the different aspects of data protection, including a document that:

• delves into the different remote medical services available in Israel;
• evaluates the privacy risks to patients;
• outlines the relevant legal regulations and guidelines; and
• provides specific recommendations for the utilisation of health and fitness applications.

The regulations were inspired by, and are generally consistent with, the European General Data Protection Regulation (GDPR).

Israeli policymakers are keeping pace with technological developments in digital healthcare through updated regulation and strategic national initiatives, making efforts to improve inter-agency collaboration. While comprehensive legislation is still evolving, the Ministry of Health has issued binding circulars regarding:

• the process of obtaining informed consent;
• the use of cloud computing in the Israeli healthcare system;
• the criteria for operating telehealth medicine;
• providing patients accessibility to personal health data (“healthcare in the palm of your hand”);
• the protection of data in computerised systems in the healthcare system;
• the rules of ethics for remote care of the Israel Medical Association, etc.

The PPA enforces data protection standards and has reviewed compliance across digital health providers.

Technical standards in Israel’s digital health sector are used to ensure interoperability, data consistency and security across healthcare systems. For example, the Ministry of Health is implementing the Fast Healthcare Interoperability Resources (FHIR) standard as part of the 2024 Medical Information Mobility Law, which aims to enable seamless and standardised data exchange between healthcare providers. Generally, the Ministry of Health circulars concerning secondary uses of health data and data-sharing collaborations define technical and procedural standards, including mandatory de-identification protocols, access control mechanisms, secure data-sharing environments, and binding confidentiality obligations.

Software as a Medical Device (SaMD)

SaMDs are regulated under several medical device registration procedures. While most technical standards, such as those related to quality management and safety, apply broadly to all medical devices, SaMD is subject to a specific requirement to submit validation and verification documents demonstrating that the software performs its intended medical function reliably and safely (Ministry of Health Procedure No REG-2024/03). This requirement applies to SaMD classified as Class III under the FDA, or as Classes IIb and III under the EU, and only in cases where the software’s safety and performance are not adequately addressed in the risk management report, clinical evaluation or the summary of clinical trials. In addition, under Ministry of Health Procedure No REG-2024/08, software changes that affect the safety or performance of medical devices (in FDA Classes II–III or EU Classes IIa–III) are classified as material changes (for example, a software update that enables Wi-Fi functionality in an insulin pump). These require the submission of a formal change request to the Ministry of Health, along with supporting documents such as updated regulatory approvals and ISO 13485 certification.

In Israel, various aspects of digital healthcare are regulated to different extents, often under general or adjacent legal frameworks rather than dedicated, standalone laws.

SaMDs

Software-based medical devices are regulated by the Ministry of Health under the Medical Devices Law, 2012. These products are registered through the Medical Accessories and Devices (MAD) division, even when they function as standalone software solutions. For example, Insulin Insights is a clinical decision support software that helps diabetes patients monitor and optimise insulin use. Another example is the CoroFlow Cardiovascular Measurement System & Accessories, which include a software component that operates in conjunction with specialised hardware to measure coronary blood flow. More complex systems such as 3D medical image processing tools and neurosurgical navigation software have also previously been registered as SaMDs. Although there is no specific statutory definition of SaMD in Israel, such products are treated as medical devices if their intended use falls within the scope of clinical diagnosis or treatment.

Wearable Technologies

Self-care, wellness and fitness IT products are generally not regulated as medical devices unless they make explicit health-related claims or provide clinical-level diagnostics or treatment. Wearable technologies used for general fitness and wellness purposes (eg, step counters, sleep monitors) are typically considered consumer products.

Data Protection

Cybersecurity and data protection in healthcare are governed primarily by the Protection of Privacy Law, 5741-1981, and the accompanying Data Security Regulations, 2017. These laws apply across sectors but are particularly critical in healthcare due to the sensitivity of medical data. The Ministry of Health has issued circulars on cloud computing, patient data access and cyber protection in the health system. The PPA also plays an active enforcement role, and has published sector-specific supervision reports addressing healthcare cybersecurity practices.

AI

There is currently no dedicated regulation addressing the use of AI or machine learning in healthcare, but AI/machine learning-powered tools used in clinical settings are subject to general medical device regulations. In April 2023, the Ministry of Health published guiding principles for the development of AI-based technologies in digital health, although these remain non-binding. These tools must still comply with existing regulatory frameworks, including those related to safety, efficacy and data protection.

Telehealth

Telehealth services are governed by a series of Ministry of Health circulars outlining, inter alia, patient accessibility, remote diagnostics and informed consent. These guidelines apply to health maintenance organisations and hospitals, and address both ethical and clinical considerations. Telehealth services became more mainstream following the COVID-19 pandemic and continue to be widely used, although no primary legislation has yet been enacted. Cross-border telehealth remains largely unregulated, with general licensing laws applying.

Israel’s current legal and regulatory framework provides oversight for digital healthcare, primarily through general laws and Ministry of Health circulars. However, significant gaps remain – particularly regarding the implementation of digital health technologies across various areas of healthcare, including AI and machine learning. The relative lack of detailed legislation has created a flexible environment that can be conducive to entrepreneurial activity and innovation, enabling start-ups and technology developers to test and iterate new products more rapidly, without the delays often associated with rigid compliance or sector-specific regulatory approvals. It also encourages greater experimentation with emerging technologies in clinical settings, as the absence of overly prescriptive rules permits a broader range of pilot programmes and adaptive development cycles. This environment has helped to position Israel as a global hub for digital health innovation, attracting both local entrepreneurs and international investment.

In Israel, digital healthcare falls under the oversight of several regulatory bodies, each tasked with specific roles.

The Ministry of Health serves as the central authority for digital healthcare regulation. It handles the registration and marketing approvals for medical devices and digital health technologies, and is responsible for regulating clinical trials. It also supervises the secondary use of health data and oversees data-sharing collaborations. It publishes circulars addressing topics such as telehealth implementation, cloud infrastructure and patient access to electronic medical records.

The Privacy Protection Authority (PPA) is the leading body responsible for data protection and cybersecurity within the digital health landscape. It regulates how databases containing personal and health data are managed, and ensures compliance with the Protection of Privacy Law. The PPA has the authority to enforce regulations in cases of unauthorised data use and conducts routine supervisory inspections. In 2024, the PPA released a supervisory report assessing digital health providers on organisational controls, data management and cybersecurity, revealing a generally high level of compliance.

The judicial system also plays an important role in digital health governance. Israeli courts have jurisdiction over regulatory disputes and enforcement matters.

As explained in 3.1 Oversight of Digital Healthcare, the PPA is a non-healthcare regulatory agency responsible for enforcing the privacy and data protection legislative scheme in Israel. It is primarily concerned with issues such as:

• the way data is collected;
• the way data is shared;
• preserving the confidentiality of private data, including health data;
• protecting against data breaches;
• managing medical terminology; and
• preventing cyber-attacks, amongst others.

Government participation is also manifested through the Authority for Innovation, which offers financial support for digital medicine projects across various fields.

Privacy and data protection are the most strongly enforced areas, largely because Israel has a dedicated legal framework for privacy, and the PPA includes a dedicated enforcement department that supervises organisations, conducts audits and makes sure companies, public bodies and non-governmental organisations comply with data protection rules. In 2024, the PPA published a supervision report evaluating digital health providers on governance, data management and security. Most showed high compliance, but about 30% had only partial compliance.

However, enforcement in areas like AI/machine learning technologies or SaMD is still evolving. While general laws apply, there are no dedicated enforcement mechanisms yet, and guidance is provided through non-binding principles and alignment with international standards.

Israel has begun to enact dedicated laws relevant to digital healthcare, such as the Medical Information Mobility Law (5784–2024). However, the broader regulatory framework still lacks comprehensive legislation tailored specifically to emerging digital health technologies such as AI, machine learning and SaMD. These areas are primarily guided by non-binding guidelines and general legal principles.

While certain risks are strongly regulated through specific laws and dedicated enforcement departments, such as privacy and data protection, the overall framework remains incomplete. There is growing recognition of the need for binding, targeted regulation to effectively address the complexities and risks posed by advanced digital tools, but no major legislative reforms have yet been enacted.

Digital healthcare in Israel presents several legal and regulatory risks, primarily due to the absence of comprehensive, binding legislation tailored specifically to this sector. While the protection of privacy and data is subject to a robust legal framework and actively enforced by the PPA, other aspects – such as AI, machine learning technologies and SaMD – remain governed primarily by non-binding circulars issued by the Ministry of Health, or by general legal principles. This regulatory framework creates uncertainty and increases the risk of non-compliance.

This gap in comprehensive regulation also affects regulatory enforcement. Enforcement activities are most developed in the field of privacy and data security, where the PPA exercises supervisory powers, conducts audits and may impose administrative or criminal sanctions. However there are currently no sector-specific enforcement mechanisms for emerging technologies, leaving a gap in regulatory clarity and accountability. This limits the ability of regulators to address sector-specific risks in a consistent and proactive manner.

These regulatory shortcomings contribute directly to heightened liability exposure for entities operating in the digital health space. Liability exposure arises under multiple legal frameworks, including tort law (primarily negligence), strict liability pursuant to the Defective Products Liability Law 5740-1980, and contractual obligations. Entities involved in the development or use of digital health technologies may be held liable for harm caused by defective or inadequately validated systems. In particular, the opaque nature of certain AI-based technologies presents challenges in establishing foreseeability and causation, complicating the allocation of legal responsibility.

The legal exposures discussed in 4.1 Legal Risks of Digital Healthcare are only partially addressed under statute. Privacy and data protection are clearly regulated under the Protection of Privacy Law, enforced by the PPA, while product liability is governed by the Defective Products Liability Law. However, other areas – such as AI, SaMD and telehealth – lack dedicated legislation or formal enforcement mechanisms, and are primarily addressed through general legal principles or non-binding guidelines.

That said, individuals and entities can always seek redress by filing a lawsuit, relying on general legal frameworks such as tort, contract, product liability, constitutional rights under the Basic Law: Human Dignity and Liberty, administrative law, consumer protection law, etc, depending on the nature of the harm or dispute.

There are several mechanisms to mitigate or defend against the legal exposures discussed in 4.1 Legal Risks of Digital Healthcare.

In Israel, entities can reduce risk by aligning with Ministry of Health circulars on digital health, such as those addressing secondary use of data, cloud computing and patient access to personal records, which, while not always binding, reflect regulatory expectations and accepted standards of practice. Implementing robust data protection measures in accordance with the Protection of Privacy Regulations (Data Security) 5777-2017, and aligning with documents published by the PPA and guidance generally consistent with the GDPR, can further support claims of regulatory compliance. Obtaining prior approval from the Helsinki Committee for research involving health data, and participating in national initiatives such as the SNOMED-CT-based medical nomenclature project, also help demonstrate responsible conduct.

In commercial contexts, contracts should allocate risk clearly through indemnities, warranties and data use provisions. In the AI context, adopting bias mitigation and transparency measures, alongside maintaining detailed documentation of compliance efforts, strengthens the ability to defend against liability claims, especially in negligence or data misuse scenarios.

In 2024, the Medical Information Mobility Law (5784–2024) was enacted, replacing earlier draft proposals. As part of its implementation, the Ministry of Health published a new plan to establish the infrastructure for adopting the FHIR standard, enabling the interoperable, secure exchange of health data across the system. The law is designed to facilitate the smooth transfer of medical information between healthcare organisations in Israel, addressing not only the shared infrastructure and data transmission standards (FHIR) but also the use of standardised terminology.

To support this, Israel established a national medical terminology framework aimed at creating a unified language across the healthcare system. This standardisation effort helps to ensure consistent, accurate data usage and improves overall co-ordination in digital healthcare.

While recent legislative and policy developments in Israel address certain aspects of digital healthcare, they do not constitute a comprehensive or sector-specific regulatory framework. The Medical Information Mobility Law (5784–2024) promotes patient access to and the portability of health data and is expected to support digital infrastructure, but it does not directly regulate digital health technologies, services or providers. As part of the implementation of the Medical Information Mobility Law, the National Terminology Infrastructure was established, with the goal of creating a unified language (standardisation) in the medical information of the healthcare system.

Similarly, Amendment No 13 to the Privacy Protection Law introduces GDPR-inspired reforms that strengthen data subject rights across sectors, including healthcare, but its scope remains general. In April 2025, the PPA published non-binding AI policy principles encouraging sector-specific regulation and ethical use, but no binding rules currently apply to AI in the medical context. As such, digital healthcare in Israel continues to operate without dedicated legislation, relying primarily on general laws, Ministry of Health circulars and evolving policy guidance.