Compliance in Digital Healthcare
Regulatory compliance, patient safety and data protection are essential in digital healthcare.
Stevn Technologies works with Nordic technology partners to provide healthcare solutions supported by product-specific regulatory documentation, applicable standards and technical testing.
Healthcare Compliance and Standards
Responsible use of digital healthcare technology requires attention to regulatory requirements, patient information, operational reliability and clinical safety. These principles guide how healthcare solutions are evaluated and introduced into care environments.
Healthcare Regulations
Healthcare technologies must be assessed according to their intended use and applicable regulatory requirements. Product classification, manufacturer responsibilities and conformity documentation are important parts of this assessment.
Data Protection
Patient information requires appropriate safeguards throughout collection, transmission, storage and access. Clear responsibilities and documented data protection arrangements support responsible use of connected healthcare solutions.
System Reliability
Reliable performance and clearly defined operational responsibilities are essential when technology becomes part of healthcare workflows. Technical evaluation, maintenance and support arrangements should reflect the clinical environment and intended use.
Patient Safety
Technology should support safe and appropriate clinical use. Intended purpose, user instructions, risk management and the responsibilities of healthcare professionals must be considered before and during implementation.
Regulatory Standards and Data Security
Digital healthcare solutions are subject to regulatory, technical and data protection requirements determined by their intended use. Product documentation, technical assessments and information security measures support evaluation and implementation in healthcare environments.
Medical Device Regulations
Medical device classification and conformity assessment are based on intended purpose and applicable EU legislation. ECG247 is classified as Class IIa under MDR (EU) 2017/745. SENS Motion has a Class I classification under MDD 93/42/EEC, as documented by the manufacturer.
Technical Standards and Testing
Product-specific technical documentation may include electromagnetic compatibility, electrical safety, mechanical testing and environmental requirements. Test reports and declarations of conformity identify the standards and requirements applicable to individual devices and configurations.
GDPR and Patient Data Protection
Healthcare organisations and technology providers must address the requirements of the General Data Protection Regulation when processing personal and health data. Data processing agreements, defined responsibilities and appropriate safeguards form part of a compliant implementation.
Secure Data Transmission
Connected healthcare solutions require appropriate protection of information exchanged between devices, applications and clinical systems. Encryption and secure communication protocols are important considerations in evaluating each solution’s technical architecture.
Access Control and Authentication
User authentication and access permissions help ensure that sensitive information is available only to authorised personnel. Role-based access and account management are important considerations for clinical platforms and remote monitoring solutions.
Secure System Integration
Integration with hospital and healthcare IT environments involves interoperability, information security and operational requirements. Interfaces, system responsibilities and deployment arrangements are evaluated according to the individual solution and healthcare organisation.
Compliance in Our Partner Technologies
Our Nordic technology partners provide healthcare solutions supported by regulatory and technical documentation relevant to their intended use. The following overview highlights key product-specific requirements and standards.
FlexCare
FlexCare, developed by Danish PowerNet ApS, is a bedside platform supporting patient information, communication, entertainment and digital care services in hospitals.
Selected FlexCare hardware models are supported by EU conformity documentation and technical test reports covering electromagnetic compatibility, electrical safety and mechanical durability.
- EN 60601-1-2 – electromagnetic compatibility testing
- EN 60601-1 – electrical safety testing for relevant equipment
- IEC 60068-2-75 – mechanical impact testing
- MIL-STD-810G – shock testing
- RoHS and REACH-related documentation
- Applicable CE and radio equipment conformity documentation
Technical documentation is available for the relevant hardware models and configurations.
ECG247
ECG247, developed by Norwegian AppSens AS, is a wearable solution for continuous, long-term ECG monitoring in hospital, outpatient and home-based care.
- MDR (EU) 2017/745
- Class IIa medical device
- CE marking under the MDR conformity assessment
- ISO 10993 – biocompatibility
- IP44 protection rating
- RoHS and REACH-related documentation
- Radio equipment compliance documentation under RED 2014/53/EU
- Bluetooth Low Energy connectivity
ECG247 connects the wearable sensor, mobile application and clinician portal. Data processing, user access and information security are managed through the manufacturer’s documented system architecture and security procedures.
SENS Motion
SENS Motion, developed by Danish SENS Innovation ApS, provides wearable monitoring of activity, mobility and rest to support assessment, rehabilitation and care planning.
- Class I medical device
- MDD 93/42/EEC
The solution supports objective monitoring of movement, activity and day-night patterns in hospitals, rehabilitation and home-based care.
Technical documentation is provided according to the applicable product configuration and intended use.
Talk2Care
Talk2Care is a digital communication application developed in collaboration with Odense University Hospital.
The application uses pictograms to help patients communicate needs and messages when verbal communication is difficult, particularly in intensive care and other clinical settings.
Talk2Care is designed to support patient communication within healthcare workflows. Relevant technical and information security requirements are assessed according to the implementation environment.
Product-specific regulatory and technical documentation can be requested through Stevn Technologies, subject to manufacturer availability.
Questions About Compliance?
For more information about regulatory documentation, technical standards or data protection relating to our healthcare solutions, please contact Stevn Technologies.