Standards and Legislation of Connected Health in the US and European Countries
- Digital Health, Tech

Standards and Legislation of Connected Health in the US and European Countries

Remote healthcare management and delivery through a viable socio-technical model encompass the standard definition of Connected Health. The existence of this healthcare management and conceptual model has a direct link to critical terms like telehealth, electronic, mobile, digital, and wireless. Connected health uses technology to provide secured remote access to health-related data. It immediately and remotely provides urgent technological healthcare solutions to patients. The technical initiative makes patient care proactive and efficient. In short, viable data, connected devices, secured communication platforms, and people are the main elements of connected health. Under the people element, patients, clinicians, and healthcare planners are empowered to relay and collect pertinent healthcare-related information flexibly.

Importance of Connected Health Standards

Improved patient engagement and seamless patient experiences are among the primary objectives of Connected Health. It qualifies as a subdomain of healthcare technology. Information technology standards are referenced in the creation of Connected Health standards. These two standards weigh-ins yield the following footprints:

Patient Data Security

Connected Health technology has led to the generation of paperless health records. Data segments are encrypted to maintain their integrity. It only permits access to authorized and authenticated healthcare users and personnel. It has led to data reliability. Protected healthcare records are dynamically usable. Only qualified doctors and health practitioners can vouch for their authenticity.

Health Data Access

Healthcare agencies linked to social services have a better grip at mandating and assessing non-medical health-related issues. Open access to health data records makes this milestone a possibility. Patients benefit from easily-derived community care management functions. It is easy to resolve a health issue without incurring the costs of travel and diagnostics to find and cure an ailment.

Global Data Connectivity  

All health care aspects can exist under one roof. Public health agencies, pharmacies, home health, and social service segments outsource and reference comparative patient records and information about a presented health issue. Timely and accurate information is available for doctors and other medical practitioners to accurately diagnose and prescribe a patient with a cure plan.

Health Data Micromanagement  

Viable health records and patient data exist under a single roof. Effective database schema based on targeted healthcare information systems is defined. It is easy to find workarounds on rare patient cases through referencing this patient care information system database. It helps set the needed pace to find cures to urgent health issues by skipping unnecessary diagnostic steps.

Connected Health Standards in the USA

These standards provide a channel for healthcare information exchange.

HEART (Health Relationship Trust)

Patients have control over stored data on a health information system. They control how, with whom, and when their health records can be accessed.


It is a common data interchange standard with specifications related to document management, scheduling, patient administration, lab tests, and diagnosis results.


Both patients, doctors, and medical practitioners can securely send and receive patient health information and records through a defined internet platform.

IEEE P2933

Health data and medical devices are existing under the IoT framework associate with this standard description. It orchestrates the principles that determine the health data connection between clinical IoT and healthcare systems’ segments like Electronic Medical Records (EMR) and Electronic Health Records (EHR).

IEEE 11073

Connected health devices communicate through this standard. It determines the rules and protocols for medical devices to link through a defined network and exchange data effectively. Secondary healthcare devices are also inclusive of this communication layer. The performance data of the health device is captured together with the client health data.

IEEE P2418.6

This connected health standard has a direct linkage with Distributed Ledger Technology (DLT). It determines how to use, implement, and interact with healthcare-defined related health systems. Since DLT determines the correct functionality for a decentralized digital health database, it also addresses the scalability and privacy concerns that might surface.

Connected Health Standards in European Countries

Healthcare External Evaluation Programs

Advises on the standard guidelines that should be followed in each health or social care program implementation. The issuance of Certifications and licenses defines the external evaluation programs’ healthcare devices’ safety, quality, and operability.

ICE 62366-1:2015

This standard caters to the usability of engineered medical devices. The manufacturer of these devices must assess and mitigate manufactured medical devices’ associated risks and errors.

EHTEL (Belgium)

Citizens of the involved countries have a say in the privacy and transparency of their health data generated from connected health devices. The involved strategies entail the certification and testing of the involved medical devices. Identifying viable data formats and secure software and hardware infrastructure for handling the targeted health data is a plus—finally, a participatory mandate for the stakeholders involved in realizing these connected health medical devices.


This standard enlists six categories that certify health devices based on their quality reassurance. The supply chain process of the involved medical devices is qualitatively assessed to conclude patient welfare. The six categories that define this standard include quality management, communication under information sciences, employee orientation, people orientation, leadership, and security. The in-depth assessment of these categories yields an outcome that propagates the improvement of the connected health devices in question.

FHIR (Fast Health Interoperability Resource)

Caters to how health data traverses through connected health medical devices. Several defined resources cater to this communication between health data and medical devices. These resources can be identified as Atomic, Connected, Independent, Simple, RESTful, Flexible, Extensible, Web-centric, and Free for use. They provide a base for the definition and implementation of FHIR standards.

ETSI TR 102 415

The rapid evolution of ICT-based medical devices has led to the development of Intelligent/connected homes. This standard seeks to level the playing field between the related health evolutionary milestones and the human factors trying to keep up with them. The factors that hold water in this standard’s definition include ethical, privacy, and security issues, provisional telecare service elements, devices’ safety and security, and the implementation of enhanced technological footprints to better the human-to-ICT interactions.

IEC 60601-1-6:2010

This standard is associated with the manufacturers of connected health hardware devices. The Safety and performance of these medical devices are essential. It provides parameters to test and rate medical devices’ usability errors. The engineering process analyses and specifies the design usability of the connected health devices in question after their verification and validation.

  • HL7 or Health Level 7 contributively defines the medical data exchange standards. How medical applications interact with health data depends on the defined data version, structure, type, and data transport methodologies.
  • The involved health standards need more insight on device innovation, Big Data analytics, and cloud computing.

Limitations of Connected Health Standardization

The acid test for global development and integration of Connected Health depends on patient engagement and data-driven decision making. Patient engagement needs convenience in terms of price transparency and helpful patient information portals. Patients need to control their medical appointments through video consults, email, live chat, and texting platforms. Data-driven decision-making needs to take an evidence-based insight approach. More data analysis is required for the final data relayed through targeted medical devices to be accurate and timely.

Standards and Legislation of Connected Health in the US and European Countries

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