7.1 Draft guideline for data users on how to use data in a secure processing environment
De publieke consultatie voor de eerste ronde van TEHDAS2 richtlijnen en specificaties is geopend. Vanuit Nederland gaan we deze feedback gezamenlijk geven. Voor correcte bundeling volgen de vragen in het Engels. De corresponderende richtlijn staat op de volgende link*. Alvast dank voor je bijdrage
Type of responder
*
Support centre for the European electronic health record exchange Format (EEHRxF) and for the interoperability and security of electronic health record systems
Interest group
Non-governmental organisation (NGO)
Patient representative
Public organisation
Private organisation
Other
Sector
*
Data Management/processing
Education and academia
Government / public administration
Health care administration
Health care provider
Information & Media
Information technology
Legal and compliance
Manufacturer of medical devices
Patient advocacy
Pharmaceutical industry
Research and development
Other
Organisation size
*
Micro (1–9 employees)
Small to medium enterprise (10–249 employees)
Large enterprise (250+ employees)
Not applicable / Individual citizen
Name
First Name
Last Name
Email
example@example.com
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From your perspective, how ready is the document to meet the expected needs?
Early draft
Advanced draft
Well-developed
Needs finalisation only
What is level of quality of the document
Low
Medium
High
Is the document clear and easy to understand? [Rate 1 (not clear nor easy to understand) – 4 (very clear and easy to understand)]
How well does the document address the key issues and challenges related to its subject matter? [Rate 1 (not well) – 4 (very well)]
How feasible and implementable do you find the recommendations presented in the document? [Rate 1 (not feasible and implementable at all) – 4 (very feasible and implementable)]
Do you have any suggestions for improving the document? Are there any additional topics or areas that should be covered? [Please provide feedback and ideas for enhancing the document] [max. 750 characters]
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What are you representing?
Health Data Access Body (HDAB)
Data holder
Data user
Trusted third party (TTP)
Data protection authority (DPA)
Secure Processing Environment (SPE) provider
Other
How experienced are you with handling data (i.e. data analysis or data curation) in a secure processing environment?
No experience (not at all)
Limited experience (1–2 per year)
Infrequent experience (on a monthly basis)
Frequent experience (on a daily basis)
What type(s) of data do you plan to make accessible or use in a secure processing environment?
Not applicable
Tables
Relational databases
Imaging data
Genomic data
Bio-sample data
Unstructured data
Other
Do you think that the guidelines support data users before submitting a data access application and/or after receiving a granted permit? Please elaborate and consider all chapters.
Are there inconsistencies or specific topics missing regarding why and when data users need a specific secure processing environment? Please elaborate.
Are there inconsistencies or specific topics missing when considering how to choose an appropriate secure processing environment? Please elaborate.
Are there inconsistencies or specific topics missing when communicating with the secure processing environment provider? Please elaborate.
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Are there inconsistencies or specific topics missing on how to get access to the secure processing environment? Please elaborate.
Do the descriptions in the guideline comply with your access procedures? Would they be implementable and what steps would need to be taken? Please elaborate.
Are there inconsistencies or specific topics missing on how to analyse data within the secure processing environment? Please elaborate.
Do the descriptions in the guideline comply with your analysis procedures for data in the secure processing environment? Would they be implementable and what steps would need to be taken? Please elaborate.
Are there inconsistencies or specific topics missing regarding controllership of data in a secure processing environment? Please elaborate.
Are there inconsistencies or specific topics missing about what happens in case of rule violation? Please elaborate.
Are there inconsistencies or specific topics missing regarding what happens after finishing the analysis and/or archiving? Please elaborate.
What are differences between the steps proposed in the guideline and your current secure processing environment infrastructure? Please elaborate.
What would be the impact on you to implement what is recommended here? Please indicate if this is applicable to you and if yes, please elaborate.
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