Data Integrity & the effect on the medical device industry

Brian O'Connell BSc MSc 6ΣGB-13 Plus experience

Senior Consultant at KPC International

November 2015

< 1 min reading time

All, A Big Trend I notice in the Pharmaceutical & Biopharmaceutical Industry is the growing importance of Data Integrity. What is the consensus of the group of the focus of the FDA & other Regulatory agencies on Data Integrity for Medical Device companies. Interestingly it seems with the transition of manual processes to Automated processes in Medical devices e.g. Stent Line Semi Automation this will become more important in the future. Please feel free to discuss & comment. Much appreciated Brian O’Connell BSc MSc Six Sigma GB

source: https://www.linkedin.com/groups/78665/78665-6072041585053364224

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Posted by Brian O'Connell BSc MSc 6ΣGB-13 Plus experience

Asked on November 16, 2015 12:00 am

427 views

like 8 comments

	Private answer Vincent Suzara Obviously, it starts with HIPAA. How is patient data being secured through routers, servers, data cores, cloud and devices used by IT and health care providers? We are long past paper-only records and realize there is no such thing as 100% security (even the DOD was hacked). Applies to clinical trials, diagnostics and therapy outcomes. Then, data persistence is at issue: how long should devices hold information? A secure wipe after each use? Possible, but not realistic. Improved automation and procedures require, respectively, machine learning and trials. Also, increased consumer participation increases the chance of unauthorized disclosure. At each stage, a risk analysis for loss of data integrity should be performed. Marked as spam like Report spam
	Private answer Brian O'Connell BSc MSc 6ΣGB-13 Plus experience Excellent Point. It seems that Data Inregrity can translate to Data Security & Tamper proofing aswell. Marked as spam like Report spam
	Private answer Karen Boyd, ASQ CQA It's amazing that personal healthcare data can be stored and accessed by staff and patients via electronic portals. However many healthcare facilities will only share or release patient records to a 3rd party via snail mail, fax, or sometimes a CD! How secure is snail mail that goes undelivered or to an incorrect address? A fax transmission can get into the wrong hands too. These are questions I have, as I wonder why a scanned / emailed pdf file wouldn't be just as "secure" as a facsimile? Marked as spam like Report spam
	Private answer Brian O'Connell BSc MSc 6ΣGB-13 Plus experience Good point Karyn- there a rights of patient confidentiality- I wonder will GAMP 6 factor this in as we live in a more digitally accessible world? Marked as spam like Report spam
	Private answer Karen Boyd, ASQ CQA Thanks Brian. I'm not familiar with GAMP 6, but I'm aware of the data limitations due to my spouse experiencing frustration at times with quality / transmission of patient records as a 3rd party requester. :) Marked as spam like Report spam
	Private answer Brian O'Connell BSc MSc 6ΣGB-13 Plus experience GAMP 5 is the last Regulatory document for Automation released - I am pre-empting that the next will be GAMP 6 Marked as spam like Report spam
	Private answer What's the IQCH Marked as spam like Report spam
	Private answer Brian O'Connell BSc MSc 6ΣGB-13 Plus experience The ICHQ's are a set of Internationally Harmonised Quality Standards i.e. ICH Q9 is for Risk Management - I hope this helps Marked as spam like Report spam

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