Health informatics. Information security management for remote maintenance of medical devices and medical information systems - Requirements and risk analysis
Health informatics. Information security management for remote maintenance of medical devices and medical information systems - Requirements and risk analysis
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Health informatics. Information security management for remote maintenance of medical devices and medical information systems - Requirements and risk analysis

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What is ISO/TS 11633-1- Health informatics about?  

ISO/TS 11633-1 focuses on remote maintenance services (RMS) for information systems in healthcare facilities (HCFs) as provided by vendors of medical devices and health information systems. 

ISO/TS 11633-1 specifies the risk assessment necessary to protect remote maintenance activities, taking into consideration the special characteristics of the healthcare field such as patient safety, regulations and privacy protections. 

ISO/TS 11633-1 provides practical examples of risk analysis to protect both the HCF and RMS provider information assets in a safe and efficient manner. These assets are primarily the information system itself and personal health data held in the information system. 

Who is ISO/TS 11633-1 - Health informatics for? 

ISO/TS 11633-1 on Health informatics is useful for: 

  • Hospitals
  • Medical diagnostics 
  • Insurance companies

Why should you use ISO/TS 11633-1 - Health informatics?  

ISO/TS 11633-1 helps the users with specific guidelines on the remote maintenance services (RMS) for information systems in healthcare facilities (HCFs). 

Guidance in ISO/TS 11633-1  is beneficial for the safe remote maintenance. The remote connections with external organizations also expose HCFs and vendors to risks regarding confidentiality, integrity and availability of information and systems; risks which previously received scant consideration. 

HCFs owners and RMS providers in ISO/TS 11633-1 will be able to obtain the following benefits: 

  • Risk assessment can result in improved efficiency. If the risk assessment document created through the use of ISO/TR 11633-2 does not fully conform to ISO/IEC 27001, ISO/TS 11633-1 can be used in part in a risk assessment of an incompatible area, thus reducing the risk assessment effort required 
  • Documented validity of the RMS security countermeasures in place will be available to third parties 

What’s changed since the last update?  

PD ISO/TS 11633-1:2019 supersedes PD ISO/TR 11633-1:2009. PD ISO/TS 11633-1:2019 includes some technical changes with respect to PD ISO/TR 11633-1:2009. These include: 

  • Complete revision to correspond to the latest editions of the reference standards, ISO/IEC 27001 and ISO/IEC 27002 
  • Addition of use case 'remote monitoring'