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The Case for Biomedical Data Traceability
There is data, data everywhere with layers of blockchain, data analytics and cybersecurity features.
Consequently, tracking and tracing biological systems data and processes are an increasingly important part of medical device and biopharmaceutical discovery, design, development, commercialization and post launch surveillance as well as basic science research. The benefits include complying with regulatory mandates, improving the security of the data, intellectual property protection, synchronization of large data sets, accurately timing electronic transfers of data, improving artificial intelligence algorithms and more.
A 2008 conference highlighted the challenges in agriculture, bioenergy, biopharmaceutical manufacturing, and medicine and, in the following 10 years, there are still substantial gaps in fulfilling the agenda.
Other traceability applications include:
- Cannabis traceability
- Food systems
- Software standards compliance and traceability
- Connecting Requirements to IP: Achieving Requirements
- Intellectual property traceability and counterfeiting
- Traceability and the internet of (medical) things
- Traceability and artificial intelligence
- Supply chain tracking and tracing
- Big data traceability and lineage
- Tracking the impact of research data
- Standardizing data derived from mobile devices during clinical trials.
As the 4th industrial revolution proceeds, traceability in many industries, including bioscience and medicine, will become increasingly important if we are reach our goals of using data to improve quality, reduce costs, protect confidentiality, conform to regulatory mandates and improve the doctor and patient experience.
Arlen Meyers, MD, MBA is the President and CEO of the Society of Physician Entrepreneurs
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