Security and compliance

What is built, described precisely.

The controls that exist in the software, described closely enough to check — including where one covers a single product rather than all of them.

In the software

Controls we can point at in the code.

Record integrity

Append-only change history

Every product records a time-stamped history of data changes attributed to a named user, on a database separate from the operational one. Audit records reject being updated or deleted — an attempt raises an error rather than succeeding quietly.

Hash-chained events

Each audit event carries the hash of the event before it. Altering a past entry breaks the chain from that point onward, which makes tampering detectable rather than merely prohibited.

Before and after values

StudyCore and Nubiss Clinical record the previous and new value of a changed field and show a field-by-field difference. TelMed's audit stream deliberately records which fields changed and their hashes rather than the values, to keep patient data out of the log.

Reason for change

StudyCore captures a reason when a record is signed or a signature is removed. No product prompts for a reason on an ordinary data edit.

Data protection

Encryption in transit

TLS is enforced with HTTP Strict Transport Security including subdomains and preload, a content security policy, secure and same-site cookies, and short session lifetimes. Database connections require TLS.

Encrypted identifiers

Nubiss Clinical encrypts national identifiers, insurance numbers and message bodies in the database, searchable only through a separate hashed value. StudyCore encrypts participant names and local record numbers — but not date of birth. Other products rely on infrastructure-level encryption only.

File storage

Uploaded documents are stored with server-side encryption and served through short-lived signed links. Uploads are checksummed and image metadata is stripped.

Pseudonymisation

StudyCore subjects carry a study identifier, sex and year of birth and no direct identifiers; identifying details are held separately. We describe this as pseudonymised, not anonymised, because re-identification remains possible by design.

Access and authentication

Role-based access

Permissions follow a role, scoped to an organisation and where relevant to a study or site. Access checks fail closed: an unmatched scope returns an empty result rather than everything.

No cross-organisation leakage

A request for another organisation's record returns not-found rather than forbidden, so the response never confirms that a record exists. This behaviour is covered by tests.

Two-factor authentication

Available in Nubiss TelMed as time-based one-time codes with printable backup codes, and enforced for administrative access. Not yet available across the other products.

Brute-force protection

Repeated failed sign-in attempts lock the account for a cool-off period. Administrative interfaces are served from a non-default path.

Electronic signature

StudyCore requires the signer's password again at the moment of signing and binds the signature to a SHA-256 hash of the record as signed, re-verified on view. Nubiss Clinical signs documents with a verification hash and a checkable certificate.

Consent and patient rights

Consent capture

Consent is recorded with its version, method, time and the person who recorded it. In TelMed a paper consent can be printed, signed, scanned back in and stored with a document hash.

Validity and supersession

A TelMed consent under § 367 SGB V is reusable for up to twelve months from the date it was given. Superseding one writes a new record rather than editing the old, so which version was in force on any past date stays reconstructable.

No electronic consent capture

There is no eConsent module and nothing collects a patient's signature on screen. Consent is either entered by the person who took it or signed on paper and scanned back in — which is a documentation step in your process, not an automated one in ours.

Data subject requests

Nubiss Clinical provides a patient data export and an erasure workflow that respects statutory medical retention periods. The other products handle access and erasure requests manually; Longevity exports adherence data as CSV and has no self-service account deletion.

Sharing permissions

Where a person's data can be shared with a care or performance team, the permission is a dated record with a defined scope. Withdrawing it is recorded rather than erasing the original grant.

Running a security review?

Send us your questionnaire. We will answer what we can evidence and say plainly where the answer is "not yet" — which is usually more useful than a confident one.