Data services (Норвегия - Тендер #42824372)

National system for implant tracking and product catalogue master data service

The regional health authorities have carried out a concept assessment for implant tracking. There is a need to obtain market information that provides insight into the available systems and services for 1) tracking implants in medical devices in risk class III and 2) a product catalogue master data service.

The system for tracking implants will be defined under § 10 of the Patient Journal Act - national treatment-oriented health register.

Through the assignment document to the regional health authorities (Norwegian: RHF) for 2019, and the supplementary document following the Storting"s consideration of Prop. 114 S (2018-2019), it was announced:

"The regional health authorities will investigate possible systems for tracking implants (medical devices in risk class 3). The review will be led by the Western Norway Regional Health Authority [Helse Vest RHF], and will take place in collaboration with the Directorate of eHealth and the Norwegian Medicines Agency."

A national system for tracking implants can give healthcare organisations insight and control over which implants a patient has, as well as which patients have a specific implant. Better visibility and faster access for healthcare professionals to information about patients and related implants can free up time, improve the quality of patient care and increase patient safety.

The plan is to establish two components:

- Product catalogue master data service A component for registering and managing basic data (master data) about implant products. The system will provide product information to stakeholders in the healthcare sector. More information about these systems can be found in the document "Annex 1 - Overall design".

- National system for implant tracking This system will be under section 10 of the Patient Journal Act - national treatment-oriented health register. The aim is to enable different applications to create and share data about implants that patients have, both within and across organisations. Data sharing of information about implants enables users to get a common picture of which patients have a given type of implant and which implants a given patient has. More information about this system can be found in the document "Annex 1 - Overall design".

The aim of this prior information notice is to inform the market of the rest of the process:

- Market dialogue 14 September - Invitations will be sent out in August with further information about registration and implementation

- Issuance of RFI following the market dialogue

-- Current questions in the following areas:

--- Tenderer information

--- Functional and technical system

--- Privacy and health data

--- Procurement and contract strategy

--- Delivery and implementation

--- Operation

-- Maintenance and support

--- Training

--- Pricing

- The deadline for submitting responses to the RFI is 1 November

The purpose of market dialogue, including the RFI, is as follows: 

- About solutions in the market to determine the scope and objectives of a possible future procurement.

- To assist the contracting authority in the planning and preparation of their own deliveries.

- To assist the contracting authority in organising the procurement in the best possible way in regard to rights, obligations and risk management. 

- To assist the contracting authority in establishing a financial framework for a procurement, and to analyse likely lifetime costs bound to the deliveries. Enquiries regarding the market dialogue must be sent through the communication module in Mercell. Attachment: Annex - 1 Overall design