"Safe Outputs" and requesting release of files from the Level 4 Server🔗
The Five Safes Framework for safe and efficient use of data🔗
OpenSAFELY follows the Five Safes framework for data access to allow safe and efficient use of data. This framework models data access into 5 independent dimensions:
- Safe projects - does the project make good use of the data?
- Safe people - are the researchers using the data trustworthy?
- Safe data - is there potential for individuals to be identified in the data?
- Safe settings - are there necessary controls on the data?
- Safe outputs - is there any residual risk in outputs being released from the environment?
All data in OpenSAFELY is pseudonymised and all projects and researchers in OpenSAFELY go through an approval process before having any access to the dataset. This ensures the “safe data”, “safe projects” and “safe people” elements of the fives safes framework are met. The application of disclosure controls and output-checking is part of the “safe outputs” dimension.
Below we cover the 4 key areas of our “safe outputs” activities:
- Researchers must only request the release of data necessary to fulfil their project purpose and apply disclosure controls to them.
- Researchers then make a request to release the data using the “release request form”.
- Two OpenSAFELY output checkers review the data being requested for release.
- OpenSAFELY releases data that meets our disclosure rules to the relevant workspace on the Jobs site.
1. Applying disclosure controls to data you request for release🔗
The assessment of the risk of re-identification attached to a piece of data and the use of appropriate methods to reduce the disclosure risk is known as statistical disclosure control (SDC). In OpenSAFELY, researchers must apply SDC at the stage where their aggregated results are ready to be outputted from the results server (the Level 4 environment) for sharing with collaborators for feedback, or for publication as papers, reports, blogs, etc. To understand what checks have to be made to outputs it is important to understand the attribute types that exist in data and how these could lead to primary or secondary disclosure. Importantly, OpenSAFELY only allows the release of data where counts less than 5 are redacted
Individual researchers who have Level 4 access have responsibility for redacting sensitive information, or choosing not to publish it at all. The study author should do everything they can to make this easy; for example, carrying out low number suppression automatically, documenting code clearly, and only selecting essential items for publication when deciding what to label as
Datasets made available for analysis may contain the following types of attributes:
- Direct identifiers - attributes that definitively identify an individual. This includes information such as name and date of birth. By design these attributes are not made available to OpenSAFELY as data shared into the OpenSAFELY platform is pseudonymised at source and then de-identified before being made available for analysis.
- Quasi-identifiers - attributes that in themselves are not direct identifiers, but in combination may allow an individual to be identified (see L. Sweeney, Simple Demographics Often Identify People Uniquely. Carnegie Mellon University, Data Privacy Working Paper 3. Pittsburgh 2000 for more detail). This includes information such as age, sex, ethnicity and region of address. In addition, quasi-identifiers can also be confidential attributes that reveal sensitive information about an individual, such as medical diagnoses and prescriptions.
Types of disclosure🔗
There are different types of disclosure risk associated with the release of data (See: Duncan, George T. and Diane Lambert. “The Risk of Disclosure for Microdata.” Journal of Business & Economic Statistics 7 (1989): 207-217):
- Identity disclosure - the association of a known individual with a data record; a single or small number of data attributes could re-identify the individual. Once an individual has been identified, you can then learn all the other data for that individual.
- Attribute disclosure - confidential information can be revealed and attributed to a subject.
- Inferential disclosure - the combination of outputs from the same source to reveal information.
- Population disclosure - released data allows you to learn something about an entire population.
Primary vs secondary disclosure🔗
Primary disclosure describes the situation where confidential data can be obtained directly from the data. An example of primary disclosure can be seen in the table below, where you can learn that only 1 member of the population who is aged 21-30 has heart disease.
|Age band||Heart disease||Population|
To prevent primary disclosure, you could choose to redact the value for this individual as done below.
Secondary disclosure is where an individual's attributes can be indirectly learned using other available information. Ane example of this is shown below, where the column totals can be used to deduce that there is only one individual in the 20-30 age band with heart disease, despite the fact this value was protected from primary disclosure by redacting the value.
|Age band||Heart disease||Population|
Secondary disclosure can also occur across different tables involving the same population. In the below tables, showing a breakdown of heart disease by age band in the total population and in males alone, there are no disclosive small numbers. However, by differencing the values in the two tables, it can be inferred that there is only one female aged 20-30 who has heart disease.
|Total Population||Age Band||Heart Disease||Population|
|Male Population||Age Band||Heart Disease||Population|
When applying disclosure controls to your outputs, you should consider the potential for both primary and secondary disclosure.
Redacting counts less than or equal to 5🔗
Before requesting files to be released, work through the moderately sensitive files in the workspace folder systematically to identify any tables, figures, and other outputted text and objects that may be a disclosure risk. The general principle is that any statistic describing 5 or fewer patients, either directly or indirectly, should be redacted. This includes:
- Redacting counts <=5 in frequency tables. The whole table, or at a minimum multiple rows within the table, should be redacted because values removed by single cell (or row, or column) redaction could be inferred from unredacted values.
- Summaries of numeric variables describing 5 or fewer patients should be redacted.
- Graphical figures whose underlying values describe 5 or fewer patients should be redacted. Figures which include print-outs of patient counts (such as KM plots) should be checked and redacted. Underlying data for plots should be checked.
- Counts of zero can be retained.
- Other outputs, such as log files that reveal information about the underlying data, should also be checked and redacted if necessary. It is very unlikely that outputs such as log files should be required for publication outside the secure environment.
- Consider rounding of results that could be at risk of secondary disclosure.
Where possible it should be clear what has been redacted, so for example do not redact table titles and category names. By convention redactions take the form [REDACTED] to make redacted elements easier to search for.
This current approach to disclosure control is conservative and deliberately reduces the need for judgement calls. It may be possible for exceptions to be made if they can be justified as being both material important for the study conclusions (i.e. providing significant public benefit) and having a very low risk of disclosure. This must be discussed with the OpenSAFELY team.
If you are unsure about anything, please email us: email@example.com.
Remember to also always check the permitted study results policy as it describes any additional rules regarding the release of data describing organisations and regions.
Guidelines for common output types🔗
There are several existing sets of SDC guidelines covering a range of output type specific considerations including:
- Handbook on Statistical Disclosure Control for Outputs
- ESSNet SDC guidelines for the checking of output based on microdata research
- Microdata output guide StatsNZ
There are also resources for extended guidance for analysis methods commonly used in OpenSAFELY:
- Regression outputs: Ritchie, Felix. Output-based disclosure control for regressions” (2012).
- Survival analysis: O’Keefe, C. M., Sparks, R. S., McAullay, D. & Loong, B. Confidentialising Survival Analysis Output in a Remote Data Access System. J. Priv. Confidentiality 4, (2012)
There is also a disclosure control section in our Q&A forum where you can ask any questions you may have.
Below are a couple of examples of common secondary disclosure issues encountered when using OpenSAFELY.
Repeated analyses When producing repeated reports at different time points, it is possible that there can be a small change in the number of people in your analysis. E.g. “number of people with condition X receiving treatment Y” increases from N to N+1). Although this is not typically likely to be disclosive, it may carry a small risk on some occasions (e.g. an individual/GP may be able to identify themselves/their patient or believe that that can do so) and therefore should be routinely avoided to minimise burden on output checking.
The solution for this is to use rounding across the entire report (to the nearest 5, 7, or 10). Rounding eliminates the need for output checkers to compare different versions of the report outputs, as no small increases can occur. It is not likely that rounding will significantly affect the report in any meaningful way. Statistical analyses can be carried out prior to rounding and the results displayed as normal provided they are classed as low risk. If only charts are shown, rounding is not always necessary, but charts should have sufficiently low resolution that any small number changes cannot be precisely determined. However, numbers could be rounded nonetheless, as this would not noticeably affect the figures.
Running similar studies There may be cases where you have run an analysis and results have been released following approval from the output checking team, but at a later date you decide you want to make changes to the analysis such as adding an extra code to a codelist. This may result in small changes in the outputs that can be disclosive, ie, <=5 individuals have the new code recorded. In these cases, you may need to wait until there has been enough change in the underlying study population (due to the movement of patients between practices) before rerunning the study.
If you are likely to release data multiple times, e.g. for initial discussion with collaborators, use rounding of outputs initially and/or a threshold substantially higher than 5 for suppressing low numbers.
2. Requesting release of outputs from the server🔗
Having applied disclosure controls to the aggregated study data, you are ready to request their release. Only specific members of the OpenSAFELY team trained in output checking have permissions to release the data. When you are ready to request a release of your aggregated results, and only the minimum outputs necessary please complete this form and email us at firstname.lastname@example.org. For each output wishing to be released you will need to provide a clear contextual description including:
- Variable descriptions
- A description and count of the underlying population for each output.
- Relationship to other data/tables which through combination may introduce secondary disclosive risks.
Only the following file types will be reviewed: HTML; TXT; CSV; TSV; SVG; JPG; JSON; PNG. (Email email@example.com if you need additional file types).
Once you have completed this form, the requested outputs will undergo independent review by two OpenSAFELY output checkers who will check that the outputs are within the scope of your original project proposal and that they do not present any disclosure risks. Please allow up to 1 week for feedback on your request.
The Permitted Study Results Policy may be updated: always check the policy before every new release request.
Tips for getting a quicker review Our resources for checking outputs are not unlimited, therefore it is advised to ensure you have all of your outputs ready at the same time for your project (or its current phase) so they can be reviewed together. Please make your outputs as understandable as possible for output checkers who will not be familiar with your project by, for example, using descriptive variable names and providing full descriptions of each output in the form provided.
Another reason to ensure your analyses are complete is that re-running your study definition a short time later (e.g. to create an additional variable) may produce small differences in the previous results, e.g. due to movement of patients or codes added retrospectively to patient records. If you have already released similar results, any small changes in new outputs may be subject to small number suppression which may prevent the new outputs being released at all. (One solution to minimise this issue is to round all of your results, e.g. to the nearest 5).
3. How are files reviewed?🔗
Before any files are released from the secure server, they are checked independently by two trained OpenSAFELY output checkers. Each checked output is marked as one of the following categories:
- Approve — output meets disclosure requirements and is safe to be released
- Approve subject to change — output is an acceptable type for release, but has outstanding disclosure issues that must be addressed before release
- Reject — output is not an acceptable type for release. An example is the release of practice level data which does not meet the permitted study results policy
Once reviewed, the completed review request will be emailed back to you. If all outputs are approved, they will then be released. If one or more outputs are approved subject to change, you will need to address the disclosure issues and submit a new review form detailing the changes you have made.
4. Release of reviewed files🔗
All approved OpenSAFELY outputs are released to the workspace they belong to on the Jobs site.
Viewing released outputs🔗
View your released outputs by navigating to "Released Outputs" in the "Releases" section of your workspace on the Jobs site.
These outputs can be shared with project collaborators and published in line with our data sharing and publication policy. Please note that you should check this for each dataset that you have used: rules may vary.
Data may only be shared with individuals without Level 4 access after they have been released outside of the secure area. You MUST NOT screen share (or share via any other means) any results that have not been released through the official process.
Reporting a data breach🔗
If you discover files released to the Jobs site that have been insufficiently redacted and still contain sensitive information, you should immediately contact and email the following (providing as much information as possible): Amir Mehrkar (firstname.lastname@example.org); Ben Goldacre (email@example.com); firstname.lastname@example.org; and your co-pilot. Ensure you do not share these files and if they have already been shared please identify as best as possible with whom they have been shared.