The Food and Drug Administration issued a draft guidance on the use of electronic systems — including EHRs, telecommunication systems and mobile technology — in clinical investigations.
As an update to the 2003 guidance, the draft details how drugmakers, clinical investigators and research organizations can ensure their electronic systems meet FDA expectations for record storage and monitoring.
Here are four notes.
1. Companies must validate electronic systems that process "critical records" — such as laboratory or study endpoint data — that will be submitted to the FDA.
2. The FDA said organizations should take security precautions — like firewall, anti-virus and anti-spyware software — to ensure access to electronic systems is limited to authorized users.
3. The FDA recommends a number of security controls for mobile technology, including thumbprint sensors and usernames and passwords. However, the agency said it does not plan to inspect individual mobile devices used in clinical trials.
4. When study data is wirelessly transmitted from mobile technologies, it must be encrypted both in transit and at rest to prevent malicious intervention.
Click here to view the full draft guidance.
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