The contracting entity provides a framework agreement on IT consultancy with 7 sub-agreements. IT consultancy services cover advisory and development tasks, as well as ongoing services associated with it. Acquisitions are made via mini tenders.

The Framework Agreement may be used by the entire Ministry of Health, consisting of:

Department, Health Data Administration, Board of Patient Safety, Health Administration,

State Serum Institute, Medicines Agency, Board of Patients Complaints, National Genome Center, National Scientific Ethics Committee and Ethical Council, and ICARS (expected self-owning institution in 2022).

The statement of the Estimated Value of the Framework Agreement in Section II.1.5) constitutes a total estimate for the full contract period based on historical figures and forward-looking expectations for all 7 sub-agreements. The maximum value of the framework agreement constitutes the value specified in point II.1.5, including a quantitative extension of 30 per cent for each sub-agreement referred to in point II.2.11, corresponding to a total maximum value of dkk 344500000.

Partial agreement A, General advice within the Ministry of Health Group. The sub-agreement is primarily used to clarify what is required by a solution to enable it to be used for business support in the areas that the Customer supports IT in the Group.

This subagreement covers tasks related to solution design, architecture design, preparation of requirements specifications and review of offerings, and project and process tasks.

Expected tasks include:

Y1. IT related strategies:

Pre-analyses, Sparring/Inspiration, AS-ice and two-be analyses, Uncovering needs with interview and workshops, Assistance in the preparation of target images

Y2. Business needs, business case, and gain realization:

Analysis and documentation of processes including transverse workflows, Process change implementation, including facilitation of workshops, Business and change processes and process optimization, Business analyses, Data flow mapping, Gain realization

Y3. IT Offering:

Preparation and Review of Claims Specifications, Review of Offer

Y5. IT Architecture:

Enterprise Architecture and Solution Architecture, Design of Architecture-Target Image, Determining

principles of realization

Y6. IT Governance:

Review of Documentation, Quality Assurance and Test, Process Analysis, Evaluation

Y7. Project and Program Management:

Program and Project Management of Health-IT Projects, Advisory tasks, including sparring/inspiration, Evaluation of projects.

- Acquisitions are expected to vary in proportion to number of hours from 100 - 3000

- Timally, tasks can vary from a few weeks to several years

- The working language is Danish

- The final scope of the Partial Agreement shall be determined by the contracting entity's actual need for consultancy services for the duration of the contract. Contracting entities are thus not required for the purchase of a predetermined scale.

- Contracting entities expect to contract with up to 7 suppliers

- Minimum requirements for the submission of 5 CVs for tendering

Sub-agreement B General development, further development, maintenance and support. The sub-agreement

is used for the general development, further development, maintenance and support of the solutions to be made for business support in the areas supported by the Customer in the Group.

This sub-agreement covers general tasks related to development, further development, maintenance and support, and the alignment of the contracting entity's business-supporting IT system portfolio.

Expected tasks include:

Y7. Project and Program Management:

Preparation of documentation on existing systems, e.g. for re-tender use

Y8. Computing:

Analysis Tasks, Database Design and Database Modeling, Data Migration

Y11. Tests:

Troubleshooting and problem identification, Quality control of project and change deliveries, Quality control test tasks

Y12. Developing new functionality:

Development tasks, both of business-supporting applications, front-end and back-end, Development of new systems that do not require a special agreement base

Y13. Customization of existing IT systems:

System integration, maintenance and support in relation to the existing system portfolio, ad. hoc. adaptation of systems based on new regulatory requirements;

Y14. IT system operation:

General business support for returning IT operations and developing own systems, managed service tasks.

- Consultancy services are expected to be acquired with effort commitment (T/M) and delivery responsibilities, both development tasks, support and maintenance tasks (Current benefits), and a combination of development and ongoing benefits

- Provision of Ongoing benefits on working days within ordinary working hours required

- Acquisitions are expected to vary in number of hours from 100 to many thousands for major development tasks with subsequent support and maintenance

- Timally, tasks can vary from a few weeks to several years

- The working language is Danish

- The final scope of the Partial Agreement shall be determined by the contracting entity's actual need for consultancy services for the duration of the contract. Contracting entities are thus not required for the purchase of a predetermined scale.

- Contracting entities expect to contract with up to 7 suppliers

- Minimum requirements for the submission of 10 CVs shall be made for tendering.

Subagreement C Content standards include the content of systems, including health IT systems. Content standards can be the classifications, terminologies, vocabularies, etc. used by the systems.

The purpose of applying the standards is to ensure maximum interoperability, by increasing a common understanding when sharing and interpreting common data. The quality of content standards also has a bearing on the functionality and facilities of a system's optimal user operability.

This sub-agreement covers tasks relating to the advice, development, implementation and maintenance of content standards and the application of substantive standardisation and classification.

Expected work assignments include:

- Redevelopment of content standards

- Continued development, further development, maintenance and support

- Audit and quality development of content standards

- Adaptation and translation of foreign standards

- Maping between content standards

- Publishing ifm. work with content standards

- Development of strategies for, inter alia, selection of content standards and implementation of standards.

- Documentation of processes related to content standards

- Advice on applicable content standards, terminology and metrology

- Advice on standardised coding, registration and reporting

- Project management and support ifm. work with content standards

- Quality assurance ifm. work with content standards

- Development and documentation of formats for machine-readable evaluation algorithms for PRO tools

- Development of tools, formats and other infrastructure for demonstrating functionality in relation to control and storage of PRO components

- Transfer concrete questionnaires to XML (HL7-CDA format) and HTML

- Standard development in relation to accidental events.

* Timally, tasks can range from a few weeks to several years

* Acquisitions are expected to vary in terms of number of hours from 100 to 1000

* Timally, tasks can range from a few weeks to several years

* The working language is Danish

* The final scope of the partial agreement shall be determined by the contracting entity's actual need for consultancy for the duration of the contract. Contracting entities are thus not required for the purchase of a predetermined scale.

* Contracting entity expects to contract with up to 5 suppliers

* Minimum requirements for the submission of 1 CV shall be made for tendering.

National infrastructure, including the National Service Platform (NSP), the Common Medicine Map (FMK), the Danish Vaccinations Register (DDV), the Health Service Organisations Register (SOR), the Health Service Electronic User Management (SEB), the Central Bystander Register (CTR) and Pharmacovigilance Submission (PVS) are important to both the Health Data Authority and the community.

NSP is the infrastructure that allows national records and services to be used directly in patient care by ensuring the necessary availability and operational stability 24/7. In addition to providing access to national services and registries, the NSP is also a technical infrastructure that includes a number of components that support the connected services.

FMK is a central database of Hänørdatastyrelsen, which contains information on the electronic prescriptions and drug purchases of all Danish citizens over the past two years, as well as an updated list of the citizen's current drug prescriptions. FMK consists of a citizen-facing access exhibited through www.health.dk and of a healthcare professional access accessed primarily through local IT systems' technical integration with FMK, secondarily through a browser solution, www.fmk-online.dk.

DDV stands for the Danish Vaccination Register. It contains information on all Danish citizens' vaccinations, including COVID-19 vaccinations and influenza vaccinations.

SEB is the Health Service's Electronic User Management and provides information on roles for people in health care.

SOR is the Health Service's Organizational Register. A registry containing organizational and address data on health care.

CTR is a nationwide electronic registry whose purpose is to ensure that the pharmacy deducts the right subsidy amount from the price of the medicine citizens buy. The pharmacy reports the subsidy price of your medication when the citizen buys medicines with subsidies. The register includes the citizen's updated balance of the subsidy prices reported by the pharmacy. Based on the size of your balance, the pharmacy knows how much the citizen should have in subsidies when buying eligible medicines.

PVS is Pharmacovigilance Submission which is used in reporting adverse reactions to medicines and vaccines.

This sub-agreement covers tasks related to consulting services related to the development, adaptation, further development, maintenance and support of NSP, FMK, DDV, SEB, SOR, CTR and PVS and related services.

Expected tasks include:

Y1. IT related strategies:

Analysis tasks, Sparring/Inspiration, Pre-analyses, AS-ice and two-be analyses, Uncovering needs with interview and workshops, Assistance in the preparation of target images

Y2. Business needs, business case, and gain realization:

Analysis and documentation of processes including transverse workflows, Process change implementation, including facilitation of workshops, Business, change processes and process optimization, Business analyses, Data flow mapping, Gain realization

Y3. IT Offering:

Preparation and Review of Claims Specifications, Review of Offer

Y5. IT Architecture:

Enterprise Architecture and Solution Architecture, Architecture-Target Image Design, Set Realization Principles, Infrastructure

Y6. IT Governance:

Review of Documentation, Quality Assurance and Test, Process Analysis, Evaluation

Y7. Project and Program Management:

Program and Project Management of Health-IT Projects, Advisory tasks, including sparring/inspiration, Evaluation of projects.

- Timally, tasks can vary from a few weeks to several years

- The acquisitions are expected to vary in terms of number of hours from 100 to 4000

- The working language is Danish

- The final scope of the Partial Agreement shall be determined by the contracting entity's actual need for consultancy services for the duration of the contract. Contracting entities are thus not required for the purchase of a predetermined scale.

- Contracting entities expect to contract with up to 7 suppliers

- Minimum requirements for the submission of 4 CVs shall be made for tendering.

National infrastructure, including the National Service Platform (NSP), the Common Medicine Map (FMK), the Danish Vaccinations Register (DDV), the Health Service Organisations Register (SOR), the Health Service Electronic User Management (SEB) and the Central Bystander Register (CTR) and Pharmacovigilance Submission (PVS) are important to both SDS and the community.

NSP is the infrastructure that allows national records and services to be used directly in patient care by ensuring the necessary availability and operational stability 24/7. In addition to providing access to national services and registries, the NSP is also a technical infrastructure that includes a number of components that support the connected services.

FMK is a central database of SDS which provides information on all Danish citizens' electronic prescriptions and medicine purchases over the past two years, as well as an updated list of the citizen's current drug prescriptions. FMK consists of a citizen-facing access exhibited through www.health.dk and of a healthcare professional access accessed primarily through local IT systems' technical integration with FMK, secondarily through a browser solution, www.fmk-online.dk.

DDV stands for the Danish Vaccination Register. It contains information on all Danish citizens' vaccinations, including COVID-19 vaccinations and influenza vaccinations.

SEB is the Health Service's Electronic User Management and provides information on roles for people in health care.

SOR is the Health Service's Organizational Register. A registry containing organizational and address data on health care.

CTR is a nationwide electronic registry whose purpose is to ensure that the pharmacy deducts the right subsidy amount from the price of the medicine citizens buy. The pharmacy reports the subsidy price of your medication when the citizen buys medicines with subsidies. The register includes the citizen's updated balance of the subsidy prices reported by the pharmacy.

PVS is Pharmacovigilance Submission which is used in reporting adverse reactions to medicines and vaccines.

This sub-agreement covers tasks related to the development, adaptation and maintenance of NSP, FMK, DDV, SEB, SOR, CTR and PVS and related services.

Expected tasks include:

Y7. Project and Program Management:

Preparation of documentation on existing systems, e.g. for re-tender use

Y8. Computing:

Analysis Tasks, Database Design and Database Modeling, Data Migration

Y11. Tests:

Troubleshooting and problem identification, Quality control of project and change deliveries, Quality control test tasks

Y12. Developing new functionality:

Development tasks, both by business-supporting applications, front-end and back-end, Development of new systems

Y13. Customization of existing IT systems:

Maintain and support systems, Maintenance and support related to the existing system portfolio, Adaptation of systems based on new regulatory requirements, System Integration.

- Consultancy services are expected to be acquired with effort commitment (T/M) and delivery responsibilities

- Timally, tasks can vary from a few weeks to several years

- Acquisitions are expected to vary in number of hours from 100 to many thousands for major development tasks with subsequent support and maintenance

- Provision of 24-hour Ongoing services required

- Working primarily agile

- The working language is Danish

- The final scope of the Partial Agreement shall be determined by the contracting entity's actual need for consultancy services for the duration of the contract. Contracting entities are thus not required for the purchase of a predetermined scale.

- Contracting entities expect to contract with up to 7 suppliers

- Minimum requirements for the submission of 10 CVs shall be made for tendering.

Partial agreement F Business Intelligence within the Ministry of Health Group. The sub-agreement is used to ensure the formation of BI solutions for a wide spectrum of data. With the rapid increase in data volumes and types, contracting entities often need to be able to put together information in new ways.

The tasks include the development and maintenance of the Health Data Administration's data warehouse, which has been developed since 2019 and is continuously being further developed and expanded with new data sources. Today, the data warehouse houses large amounts of statistical data relating to the Land Patient Register (LPR), as well as a wide range of other data sources in the health field.

The data warehouse has been developed with a focus on basic statistical data on treatment and course of the disease, as well as consumption of medicines, among other things. The primary catchers of data are the Danish regions, municipalities, RKKP as well as analysts internally in the Hørndatastyrelsen. The data warehouse is built based on a Microsoft Technology Stack.

Expected work tasks include:

Development of BI solutions based on SAS and Microsoft technology, as mentioned below:

• Microsoft SQL

• IBM DB2

• Microsoft SSRS, SSIS, SSAS

• PowerBi

• SAS Enterprise + Studio - including BI and Analytics Software from SAS Institute

- Timally, tasks can vary from a few weeks to several years

- The acquisitions are expected to vary in terms of number of hours from 100 to many thousands for major development tasks

- The final scope of the Partial Agreement shall be determined by the contracting entity's actual need for consultancy services for the duration of the contract. Contracting entities are thus not required for the purchase of a predetermined scale.

- Contracting entities expect to contract with up to 7 suppliers

- Minimum requirements for the submission of 5 CVs shall be made for tendering.

Partial agreement G, Advice in GxP, QA and Laboratory Systems. The sub-agreement is primarily used to clarify what is required by an IT solution in order to comply with the regulations and guidelines both in relation to GxP, GDPR and other regulations. The sub-agreement covers the tasks of this. IT and software solutions used in monitoring and diagnosing both human and veterinary diseases, IT solutions used in research and systems supporting the aforementioned. The subagreement is expected to be used primarily by the State Serum Institute

Expected work tasks include:

• Ongoing monitoring and advice on standards, requirements and guidelines within GxP IT (GAMP5 and Annex 11)

• Advice around requirements and guidelines between GCP IT QMS and Information Security Management System (ISMS) and Privacy Information Management System (PIMS)

• Consulting around collaboration with system vendor during project phase and implementation, including configuration and migration

• Establishment and maintenance of validation plan and validation documentation

• Establishment and maintenance of user manuals

• Information Security and Data Protection Activities (GDPR) from an IT technical perspective

• Preparation of System Impact Assessments

• Treatment of deviations, CAPA and alteration cases within GxP IT

• Drive, facilitate and/or perform risk assessments including risk register

• Establish and maintain system directory for GAMP5 systems

• Review and quality assurance of requirements specifications (URS) for GAMP5 systems in procurement, as well as evaluation of offerings

• Reviewe and approve periodic reviews of GxP IT systems

• Advice around audits within GxP IT

• Export of audits within GxP IT

• Validation of IT systems (CSV)

• Software validation

• Technical Project Management.

- Timally, tasks can vary from a few weeks to several years

- The acquisitions are expected to vary in proportion to the number of hours from 100 to 1000

- Timally, tasks can vary from a few weeks to several years

- The working language is Danish

- The final scope of the Partial Agreement shall be determined by the contracting entity's actual need for consultancy services for the duration of the contract. Contracting entities are thus not required for the purchase of a predetermined scale.

- Contracting entities expect to contract with up to 5 suppliers

- Minimum requirements for the submission of 1 CV shall be made for tendering.