+Artikel 36 Förhandssamråd
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Artikel 36 Förhandssamråd

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1. Översikt

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Artikel 36 1.
Den personuppgiftsansvarige ska samråda med tillsynsmyndigheten före behandling om en konsekvensbedömning avseende dataskydd enligt artikel 35 visar att behandlingen skulle leda till en hög risk om inte den personuppgiftsansvarige vidtar åtgärder för att minska risken.
Artikel 36 2.
Om tillsynsmyndigheten anser att den planerade behandling som avses i punkt 1 skulle strida mot denna förordning, särskilt om den personuppgiftsansvarige inte i tillräcklig mån har fastställt eller reducerat risken, ska tillsynsmyndigheten inom en period på högst åtta veckor från det att begäran om samråd mottagits, ge den personuppgiftsansvarige och i tillämpliga fall personuppgiftsbiträdet skriftliga råd och får utnyttja alla de befogenheter som den har enligt artikel 58. Denna period får förlängas med sex veckor beroende på hur komplicerad den planerade behandlingen är. Tillsynsmyndigheten ska informera den personuppgiftsansvarige och, i tillämpliga fall, personuppgiftsbiträdet om en sådan förlängning inom en månad från det att begäran om samråd mottagits, tillsammans med orsakerna till förseningen. Dessa perioder får tillfälligt upphöra att löpa i avvaktan på att tillsynsmyndigheten erhåller den information som den har begärt med tanke på samrådet.
Artikel 36 3.

Vid samråd med tillsynsmyndigheten enligt punkt 1 ska den personuppgiftsansvarige till tillsynsmyndigheten lämna

a) 

i tillämpliga fall de respektive ansvarsområdena för de personuppgiftsansvariga, gemensamt personuppgiftsansvariga och personuppgiftsbiträden som medverkar vid behandlingen, framför allt vid behandling inom en koncern,

b) 

ändamålen med och medlen för den avsedda behandlingen,

c) 

de åtgärder som vidtas och de garantier som lämnas för att skydda de registrerades rättigheter och friheter enligt denna förordning,

d) 

i tillämpliga fall kontaktuppgifter till dataskyddsombudet,

e) 

konsekvensbedömningen avseende dataskydd enligt artikel 35, och

f) 

all annan information som begärs av tillsynsmyndigheten.
Artikel 36 4.
Medlemsstaterna ska samråda med tillsynsmyndigheten vid utarbetandet av ett förslag till lagstiftningsåtgärd som ska antas av ett nationellt parlament eller av en regleringsåtgärd som grundar sig på en sådan lagstiftningsåtgärd som rör behandling.
Artikel 36 5.
Trots vad som sägs i punkt 1 får det i medlemsstaternas nationella rätt krävas att personuppgiftsansvariga ska samråda med, och erhålla förhandstillstånd av, tillsynsmyndigheten när det gäller en personuppgiftsansvarigs behandling för utförandet av en uppgift som den personuppgiftsansvarige utför av allmänt intresse, inbegripet behandling avseende social trygghet och folkhälsa.

1.1 Referenser

1.2 Identifierade krav

1.3 Relaterade standarder

2. Identifierade krav

Krav

3. Relaterade 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.