+Artikel 36 Forudgående høring
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Artikel 36 Forudgående høring

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1. Oversigt

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Artikel 36 1.
Den dataansvarlige hører tilsynsmyndigheden inden behandling, såfremt en konsekvensanalyse vedrørende databeskyttelse foretaget i henhold til artikel 35 viser, at behandlingen vil føre til høj risiko i mangel af foranstaltninger truffet af den dataansvarlige for at begrænse risikoen.
Artikel 36 2.
Hvis tilsynsmyndigheden finder, at den planlagte behandling omhandlet i stk. 1 overtræder denne forordning, navnlig hvis den dataansvarlige ikke tilstrækkeligt har identificeret eller begrænset risikoen, skal tilsynsmyndigheden inden for en periode på op til otte uger efter modtagelse af anmodningen om høring give den dataansvarlige og, hvor det er relevant, databehandleren skriftlig rådgivning og kan i den forbindelse anvende enhver af sine beføjelser, jf. artikel 58. Denne periode kan forlænges med seks uger under hensyntagen til den påtænkte behandlings kompleksitet. Tilsynsmyndigheden underretter den dataansvarlige og, hvor det er relevant, databehandleren om enhver sådan forlængelse senest en måned efter modtagelse af anmodningen om høring sammen med begrundelsen for forsinkelsen. Disse perioder kan suspenderes, indtil tilsynsmyndigheden har modtaget oplysninger, som den har anmodet om med henblik på høringen.
Artikel 36 3.

Når tilsynsmyndigheden skal høres i henhold til stk. 1, indgiver den dataansvarlige følgende til tilsynsmyndigheden:

a) 

hvor det er relevant, ansvarsområderne for henholdsvis den dataansvarlige, fælles dataansvarlige og databehandleren, der er involveret i behandlingen, navnlig med hensyn til behandling inden for en koncern

b) 

den planlagte behandlings formål og hjælpemidler

c) 

foranstaltninger og garantier til beskyttelse af de registreredes rettigheder og frihedsrettigheder i henhold til denne forordning

d) 

hvor det er relevant, databeskyttelsesrådgiverens kontaktoplysninger

e) 

konsekvensanalysen vedrørende databeskyttelse i henhold til artikel 35, og

f) 

andre oplysninger, som tilsynsmyndigheden anmoder om.
Artikel 36 4.
Medlemsstaterne hører tilsynsmyndigheden som led i udarbejdelse af et forslag til lovgivningsmæssige foranstaltninger, som skal vedtages af et nationalt parlament, eller af en regulerende foranstaltning, der har hjemmel i en sådan lovgivningsmæssig foranstaltning, som vedrører behandling.
Artikel 36 5.
Uanset stk. 1 kan det i medlemsstaternes nationale ret kræves, at dataansvarlige hører og opnår forudgående tilladelse fra tilsynsmyndigheden i forbindelse med en dataansvarligs behandling under udførelsen af en opgave i samfundets interesse, herunder behandling i forbindelse med social sikring og folkesundhed.

1.1 Referencer

1.2 Identificerede krav

1.3 Relaterede standarder

2. Identificerede krav

Krav

3. Relaterede standarder

Standarder
SCF Risk Catalog

Description

Mechanisms exist to develop and keep current a catalog of applicable risks associated with the organization's business operations and technologies in use.

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ Risk Management Program (RMP)
∙ Documented risk catalog

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ Risk Management Program (RMP)
∙ Documented risk catalog

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ Risk Management Program (RMP)
∙ Documented risk catalog

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ Risk Management Program (RMP)
∙ Documented risk catalog

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ Risk Management Program (RMP)
∙ Documented risk catalog

SCR-CMM

Level 0 Not Performed

Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.

Level 1 Performed Informally

Risk Management (RSK) domain capabilities are ad hoc and inconsistent. Capability criteria associated with this control may include:
▪ Policies, standards & procedures associated with RSK domain capabilities provide limited coverage due to the depth and breadth of the existing documentation.
▪ Risk management-related activities are decentralized (e.g., a localized/regionalized function) and uses non-standardized methods to implement secure, resilient and compliant practices.
▪ IT and/or cybersecurity personnel use an informal process to identify, assess, remediate and report on risk.
▪ Risk management processes (e.g., risk assessments) focus on protecting High Value Assets (HVAs), including environments where sensitive/regulated data is stored, transmitted and processed.
▪ Data/process owners are expected to self-manage risks associated with their Technology Assets, Applications, Services and/or Data (TAASD), based on the organization's published policies and standards, including the identification, remediation and reporting of risks.

Level 2 Planned Tracked

Risk Management (RSK) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with RSK domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with RSK domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with RSK domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Risk management-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Risk management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Risk management processes (e.g., risk assessments) and technologies focus on protecting High Value Assets (HVAs), including environments where sensitive/regulated data is stored, transmitted and processed.
▪ IT and/or cybersecurity personnel implement and maintain a form of Risk Management Program (RMP) that provides operational guidance on how risk is identified, assessed, remediated and reported.
▪ Data/process owners are expected to self-manage risks associated with their systems, applications, services and data, based on the organization's published policies and standards, including the identification, remediation and reporting of risks.

Level 3 Well Defined

Risk Management (RSK) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with RSK domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with RSK domain capabilities are well-documented and kept current by process owners.
▪ A risk management team, or similar function, is appropriately staffed and supported to implement and maintain RSK domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of risk management operations (e.g., risk management solution, GRC platform and TPRM tool).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with RSK domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to develop and keep current a catalog of applicable risks associated with the organization's business operations and technologies in use.

Level 4 Quantitatively Controlled

Utilize SCR-CMM Level 3 criteria definitions:
▪ There are no defined Level 4 criteria, since it is reasonable to assume a quantitatively-controlled process is not necessary to operationalize this control.
▪ While it may be possible to develop “metrics-driven” capabilities for this control, the criteria would be organization-specific to define.

Level 5 Continuously Improving

Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
SCF Data Protection Impact Assessment (DPIA)

Description

Mechanisms exist to conduct a Data Protection Impact Assessment (DPIA) on Technology Assets, Applications and/or Services (TAAS) that store, process and/or transmit Personal Data (PD) to identify and remediate reasonably-expected risks.

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ Risk Management Program (RMP)
∙ Data Protection Impact Assessment (DPIA)
∙ Privacy Impact Assessment (PIA)

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ Risk Management Program (RMP)
∙ Data Protection Impact Assessment (DPIA)
∙ Privacy Impact Assessment (PIA)

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ Risk Management Program (RMP)
∙ Data Protection Impact Assessment (DPIA)
∙ Privacy Impact Assessment (PIA)

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ Risk Management Program (RMP)
∙ Data Protection Impact Assessment (DPIA)
∙ Privacy Impact Assessment (PIA)

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ Risk Management Program (RMP)
∙ Data Protection Impact Assessment (DPIA)
∙ Privacy Impact Assessment (PIA)

SCR-CMM

Level 0 Not Performed

Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.

Level 1 Performed Informally

SCR-CMM Level 1 criteria definitions are not available for this control:
▪ A reasonable person would conclude this control requires a structured process.
▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality.

Level 2 Planned Tracked

Risk Management (RSK) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with RSK domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with RSK domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with RSK domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Risk management-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Risk management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Risk management processes (e.g., risk assessments) and technologies focus on protecting High Value Assets (HVAs), including environments where sensitive/regulated data is stored, transmitted and processed.
▪ IT and/or cybersecurity personnel implement and maintain a form of Risk Management Program (RMP) that provides operational guidance on how risk is identified, assessed, remediated and reported.
▪ Data/process owners are expected to self-manage risks associated with their systems, applications, services and data, based on the organization's published policies and standards, including the identification, remediation and reporting of risks.
▪ Business process owners (BPOs) are made aware of cybersecurity and data protection risk(s).

Level 3 Well Defined

Risk Management (RSK) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with RSK domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with RSK domain capabilities are well-documented and kept current by process owners.
▪ A risk management team, or similar function, is appropriately staffed and supported to implement and maintain RSK domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of risk management operations (e.g., risk management solution, GRC platform and TPRM tool).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with RSK domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to conduct a Data Protection Impact Assessment (DPIA) on Technology Assets, Applications and/or Services (TAAS) that store, process and/or transmit Personal Data (PD) to identify and remediate reasonably-expected risks.

Level 4 Quantitatively Controlled

Risk Management (RSK) capabilities, in addition to being standardized across the entity and centrally managed to ensure consistency across Technology Assets, Applications, Services and/or Data (TAASD), efforts are metrics driven to provide sufficient insight for decision makers to predict optimal performance, ensure continued operations and/or identify areas for improvement. Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Applicable SCR-CMM Level 3 (Well Defined) capabilities are implemented and operational.
▪ Metrics reporting includes quantitative analysis of Key Performance Indicators (KPIs).
▪ Metrics reporting includes quantitative analysis of Key Risk Indicators (KRIs).
▪ Scope of metrics, KPIs and KRIs covers organization-wide cybersecurity and data protection controls, including functions performed by third-parties.
▪ Organizational leadership maintains a formal process to objectively review and respond to metrics, KPIs and KRIs (e.g., monthly or quarterly review).
▪ Based on metrics analysis, process improvement recommendations are submitted for review and are handled in accordance with change control processes.
▪ Business and technical stakeholders are involved in reviewing and approving proposed changes to evolve capabilities.

Level 5 Continuously Improving

Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.
SCF Data Protection Impact Assessment (DPIA)

Description

Mechanisms exist to conduct a Data Protection Impact Assessment (DPIA) on Technology Assets, Applications and/or Services (TAAS) that store, process and/or transmit Personal Data (PD) to identify and remediate reasonably-expected risks.

Possible Solutions & Considerations

Micro-Small Business (<10 staff) / BLS Firm Size Classes 1-2

∙ Risk Management Program (RMP)
∙ Data Protection Impact Assessment (DPIA)
∙ Privacy Impact Assessment (PIA)

Small Business (10-49 staff) / BLS Firm Size Classes 3-4

∙ Risk Management Program (RMP)
∙ Data Protection Impact Assessment (DPIA)
∙ Privacy Impact Assessment (PIA)

Medium Business (50-249 staff) / BLS Firm Size Classes 5-6

∙ Risk Management Program (RMP)
∙ Data Protection Impact Assessment (DPIA)
∙ Privacy Impact Assessment (PIA)

Large Business (250-999 staff) / BLS Firm Size Classes 7-8

∙ Risk Management Program (RMP)
∙ Data Protection Impact Assessment (DPIA)
∙ Privacy Impact Assessment (PIA)

Enterprise (> 1,000 staff) / BLS Firm Size Class 9

∙ Risk Management Program (RMP)
∙ Data Protection Impact Assessment (DPIA)
∙ Privacy Impact Assessment (PIA)

SCR-CMM

Level 0 Not Performed

Practices are non-existent, based on the inability to demonstrate an implemented and operational capability. A reasonable person would conclude the control is not being performed.

Level 1 Performed Informally

SCR-CMM Level 1 criteria definitions are not available for this control:
▪ A reasonable person would conclude this control requires a structured process.
▪ At this level of maturity, the "ad hoc" nature of performing a capability informally would indicate the intent of the control is not met due to a lack of consistency and formality.

Level 2 Planned Tracked

Risk Management (RSK) capabilities are requirements-driven, but are not standardized across the entity (e.g., local/regional level consistency). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with RSK domain capabilities are formally documented and centrally-managed by the entity.
▪ Standardized Operating Procedures (SOP) associated with RSK domain capabilities are documented and maintained by process owners.
▪ IT and/or cybersecurity personnel work with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with RSK domain capabilities to address applicable statutory, regulatory and/or contractual requirements for Technology Assets, Applications, Services and/or Data (TAASD).
▪ Risk management-related controls are primarily administrative and preventative in nature (e.g., policies, standards and procedures & guidelines).
▪ Risk management may be a defined function (e.g., team or department) or assigned as an additional duty to existing IT and/or cybersecurity personnel.
▪ Risk management processes (e.g., risk assessments) and technologies focus on protecting High Value Assets (HVAs), including environments where sensitive/regulated data is stored, transmitted and processed.
▪ IT and/or cybersecurity personnel implement and maintain a form of Risk Management Program (RMP) that provides operational guidance on how risk is identified, assessed, remediated and reported.
▪ Data/process owners are expected to self-manage risks associated with their systems, applications, services and data, based on the organization's published policies and standards, including the identification, remediation and reporting of risks.
▪ Business process owners (BPOs) are made aware of cybersecurity and data protection risk(s).

Level 3 Well Defined

Risk Management (RSK) capabilities are standardized across the entity for applicability to People, Processes, Technologies, Data and/or Facilities (PPTDF) to ensure consistency for Technology Assets, Applications, Services and/or Data (TAASD). Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Policies and standards associated with RSK domain capabilities are formally documented and centrally-managed by the entity's Governance, Risk & Compliance (GRC) team, or similar function.
▪ Standardized Operating Procedures (SOP) associated with RSK domain capabilities are well-documented and kept current by process owners.
▪ A risk management team, or similar function, is appropriately staffed and supported to implement and maintain RSK domain capabilities.
▪ Technology is leveraged to enhance the efficiency and accuracy of risk management operations (e.g., risk management solution, GRC platform and TPRM tool).
▪ The entity's Governance, Risk & Compliance (GRC) team, or similar function, works with business stakeholders and process owners to appropriately scope and reasonably implement cybersecurity and data protection controls associated with RSK domain capabilities to address Minimum Compliance Requirements (MCR) (e.g., applicable statutory, regulatory and/or contractual requirements) and Discretionary Security Requirements (DSR) (e.g., entity-required controls).
▪ An implemented and operational capability exists to conduct a Data Protection Impact Assessment (DPIA) on Technology Assets, Applications and/or Services (TAAS) that store, process and/or transmit Personal Data (PD) to identify and remediate reasonably-expected risks.

Level 4 Quantitatively Controlled

Risk Management (RSK) capabilities, in addition to being standardized across the entity and centrally managed to ensure consistency across Technology Assets, Applications, Services and/or Data (TAASD), efforts are metrics driven to provide sufficient insight for decision makers to predict optimal performance, ensure continued operations and/or identify areas for improvement. Capability criteria associated with this control reasonably expect the following criteria to exist:
▪ Applicable SCR-CMM Level 3 (Well Defined) capabilities are implemented and operational.
▪ Metrics reporting includes quantitative analysis of Key Performance Indicators (KPIs).
▪ Metrics reporting includes quantitative analysis of Key Risk Indicators (KRIs).
▪ Scope of metrics, KPIs and KRIs covers organization-wide cybersecurity and data protection controls, including functions performed by third-parties.
▪ Organizational leadership maintains a formal process to objectively review and respond to metrics, KPIs and KRIs (e.g., monthly or quarterly review).
▪ Based on metrics analysis, process improvement recommendations are submitted for review and are handled in accordance with change control processes.
▪ Business and technical stakeholders are involved in reviewing and approving proposed changes to evolve capabilities.

Level 5 Continuously Improving

Utilize SCR-CMM Level 3 or Level 4 (if available) criteria definitions:
▪ There are no defined Level 5 criteria, since it is reasonable to assume a continuously-improving process is not necessary to operationalize this control.
▪ Level 5 capabilities should be considered “world-class” where the control builds on Level 4 capabilities, but are continuously improving through Artificial Intelligence (AI) and/or Machine Learning (ML) technologies.
▪ While it may be possible to develop responsive capabilities for this control through the use of AI and/or ML technologies, the criteria would be organization-specific to define.