The Case for Biomedical Data Traceability

Arlen Meyers, MD, MBA 19/06/2018 4

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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Arlen Meyers, MD, MBA

Former Contributor

Arlen Meyers, MD, MBA is a professor emeritus of otolaryngology, dentistry, and engineering at the University of Colorado School of Medicine and the Colorado School of Public Health and President and CEO of the Society of Physician Entrepreneurs at www.sopenet.org. He has created several medical device and digital health companies. His primary research centers around biomedical and health innovation and entrepreneurship and life science technology commercialization. He consults for and speaks to companies, governments, colleges and universities around the world who need his expertise and contacts in the areas of bio entrepreneurship, bioscience, healthcare, healthcare IT, medical tourism -- nationally and internationally, new product development, product design, and financing new ventures. He is a former Harvard-Macy fellow and In 2010, he completed a Fulbright at Kings Business, the commercialization office of technology transfer at Kings College in London. He recently published "Building the Case for Biotechnology." "Optical Detection of Cancer", and " The Life Science Innovation Roadmap". He is also an associate editor of the Journal of Commercial Biotechnology and Technology Transfer and Entrepreneurship and Editor-in-Chief of Medscape. In addition, He is a faculty member at the University of Colorado Denver Graduate School where he teaches Biomedical Entrepreneurship and is an iCorps participant, trainer and industry mentor. He is the Chief Medical Officer at www.bridgehealth.com and www.cliexa.com and Chairman of the Board at GlobalMindED at www.globalminded.org, a non-profit at risk student success network. He is honored to be named by Modern Healthcare as one of the 50 Most Influential Physician Executives of 2011 and nominated in 2012 and Best Doctors 2013.

The Case for Biomedical Data Traceability