Perhaps you caught the President’s Executive Order1 on May 2, 1019 ordering several agencies to develop plans to train a workforce in cybersecurity technology. Analytical laboratories can expect that some lab staff will need to consider data integrity as part of Good Laboratory Practice. Data integrity includes data generation and storage (data quality), which is covered by 21 CFR Part 11, plus data security for communication. What would happen if a hacker changed a control specification or moved the decision point on a pass/fail test? Please see the short video from NIST.2
Hackers look to easy or unprotected portals to data stations. The Internet of Things (IoT) just might be such a weak link. Our lab instruments might become portals to the enterprise IT. Since lab items will be generating data continuously, they may be vulnerable to hacking after the password-protected sign-on.
The other part of the President’s order will create a specialty in the work force dealing with cybersecurity. As chemists and life science researchers, we have a good understanding of technical matters. Our work product is extremely valuable. As generators of critical information, we should expect that we will need training in cybersecurity technology. This will probably start small; however, it will grow. I predict that after a few years, the complexity will overshoot and become too burdensome. Anticipating this, NIST has been charged with developing a “light encryption” technology.
Last year, NIST published a description of the “Encryption Light” program,3 and last week posted the first 56 products that met their selection criteria.4 It is a formidable task to evaluate 56 programs. I randomly selected titles that caught my eye. “Sparkle” was my first choice. However, the initial set will be formally and rigorously evaluated, along with later submissions in about a year.
The take-home message is that a new set of requirements is heading your way, so be prepared. If the opportunity presents itself, go for it. Your experience with the analytical technology, data, and how it is all used will put you in the driver’s seat.
With a smile,
Bob
References
- https://www.whitehouse.gov/presidential-actions/executive-order-americas-cybersecurity-workforce/
- https://www.nist.gov/video/what-internet-things-iot-and-how-can-we-secure-it
- https://csrc.nist.gov/projects/lightweight-cryptography
- https://csrc.nist.gov/projects/lightweight-cryptography/round-1-candidates
Robert L. Stevenson, Ph.D., is Editor Emeritus, American Laboratory/Labcompare; e-mail: [email protected]
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