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May 12, 2017
In healthcare, the audit trail or metadata is highly relevant evidence as to who accessed what in the record, what entries were made and/or changed by whom and when. The audit trail is an integral part of the medical record. It is the metadata about the medical record that cannot be separated from the record itself. Audit logs are also critical in providing forensic evidence during cyber security incidents and responses as well as detecting potential threats and intrusions. Native audit logs can be tampered with and altered; this is why a redundant and immutable audit trail is imperative on many levels.
May 3, 2017
In 2013, members of the U.S. drug supply chain requested that Congress create a law that would govern the identification, management and traceability of all drug products within the United States. As a result, in 2013 The Drug Supply Chain Security Act (DSCSA) was adopted with the aim to facilitate the exchange of information (end-to-end traceability) at the individual package level to provide visibility about where a drug has been in the supply chain. This will enable verification of the legitimacy of the drug product identifier down to the package level, enhance detection and notification of illegitimate products in the drug supply chain and facilitate more efficient recalls of drug products.
April 16th, 2017
ULedger’s proprietary Blockchain technology provides proof & certainty to the integrity of email transactions. Organizations and their stakeholders are increasingly susceptible to cyber criminals & fraud via email transactions. ULedger acts as a “digital witness” of digital communication content
April 15th, 2017
FDA Issues Draft Guidance on Data Integrity
In April of 2016, the FDA issued the long-awaited data integrity draft guidance which sought to address the rise in data and record-keeping lapses. The draft also defined key terms such as data integrity, meta data, electronic signatures, audit trail and backup. Also addressed were the concerns surrounding shared log-ins, how often and by whom should audit trails should be reviewed and the use of electronic signatures.