Regulatory compliant (FDA 21 CFR Part 11) research studies are reimagined when the latest mobile health (mHealth) technology meets facial recognition technology. By using Face ID®, research professionals have faster, more secure access to TrialKit to build, manage, and analyze studies.
RENO and TAHOE, Nev. (PRWEB) November 06, 2018
Crucial Data Solutions announces the latest update to their native mobile app for clinical trial data collection and management. TrialKit™, an eClinical platform, has incorporated Apple’s biometric technologies for user authentication. Now, iPhone users with compatible generation devices can quickly and easily sign in to the app via facial recognition or fingerprint recognition.
Regulatory compliant (FDA 21 CFR Part 11) research studies are reimagined when the latest mobile health (mHealth) technology meets facial recognition technology. By using Face ID®, research professionals have faster, more secure access to TrialKit to build, manage, and analyze studies. They will no longer worry that their username and password may fall into the wrong hands or lost devices where the user opted to stay signed in.
Likewise, study participants using TrialKit to complete electronic patient-reported outcomes (ePRO) will feel more comfortable inputting data for a clinical trial. This will create a more robust audit trail and offer streamlining in the adjudication of trial data. In turn, this should also help improve patient compliance and engagement rates. Researchers and patients access the same app and are therefore protected by the same security measures.
Data security is always a concern on the clinical research front. This new method of authentication safeguards sensitive patient data at an unmet level. The likelihood of someone being able to access any given user’s iPhone via Face ID is 1 in 1,000,000. Authentication using Face ID provides 1024 bit encryption - data security that paper-based clinical studies or studies using simple password data encryption cannot achieve. This exceeds National Institute of Standards and Technology (NIST) standards by utilizing encryption that is several thousand times greater than this current standard. NIST recommends the use of Advanced Encryption Standard (AES) 128, 192 or 256-bit encryption, OpenPGP, and S/MIME.
And, according to Apple’s Face ID Security Guide, apps that use Face ID are notified “only as to whether the authentication was successful; it can’t access Face ID or the data associated with the enrolled face.” Users of TrialKit can be confident that the app cannot access any Face ID data associated with the device.
Study administrators will also have the ability to enforce exclusive biometric authentication. This means all the users and participants, within a study, will be required to sign in with Touch ID® or Face ID and restricted from the old email/password identification system. Mandating the use of face recognition technology will help curb false authentications and maintain data integrity.
When reached for comment about the future of Face ID in clinical settings, Dr. Leigh J Mack, CMO at Crucial Data Solutions, elaborates, “Currently, facial recognition systems are currently being used in some medical check-in systems at oncology clinics. The main advantage of facial recognition system for clinical trials are:
- Higher level of data and personal information security
- True participant recognition - not someone else logging in to report a result or outcome, e.g., provider or medical staff when the participant is supposed to provide the information
- Dosage accountability - single use dosage (UPC with specific serial number) could be scanned along with the face of participant for elevated compliance.”
TrialKit is available on the App Store® today and can also be found on Google Play for Android devices. TrialKit on Android currently has support for fingerprint authentication, and is awaiting Android mobile support for facial recognition being available to third party apps. Rest assured, TrialKit will be onboard as soon as it’s made available.
About Crucial Data Solutions, Inc.
Crucial Data Solutions, Inc. is a forward-thinking company dedicated to developing innovative technologies that reduce the cost of medical research by equipping clinical professionals with the tools they need to advance treatments that enable patients with life-altering conditions to lead better lives. We believe clinical research should be a true partnership between ourselves, research professionals, caregivers, and patients worldwide.
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