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Tightening Bio Data Rules

Updated: Sep 16, 2022

The White House released an executive order on 9/12/2022 which amounts to a “shot across the bow” for companies in the Bioeconomy. It will affect global enterprises and US Government based agencies in health care/medicine.


EkaLore focuses on finding the value in enterprise data. This order has broad implications for data in the Bioeconomy.


The recent action by the USA Federal Executive branch (White House) focused on data in the biomedical/health area termed “Data for the Bioeconomy” with a “Data for the Bioeconomy Initiative (Data Initiative)”.

(Presidential Executive Order



The broad outlines of the Data Initiative are important as they consider more than the “databases” or “programming”:


1) The scope of the Data Initiative covers data (genomic and multiomic) and sources in health, climate, energy, food, agriculture, biomanufacturing, and other bioeconomy-related R&D. Especially important are specific steps to identify and define any data gaps.


2) For all this data accessibility using platform tools is an objective (findable, accessible, interoperable, and reusable in ways that are equitable, standardized, secure, transparent and integrated with platforms enabling advanced computing tools)


3) Considers multiple attributes and metadata in a protection scheme (security (integrity covering misuse, manipulation, destruction, copying), privacy, intellectual property)


4) Changes rules for software used/procured by the USA Federal Government for bio-related software (laboratory equipment, instrumentation, and data management) including the software security measures previously described by USA NIST covering supply chains, software development, IoT (embedded) software recommendations for consumer devices, and security updates for in-use software (including free and open source)


The Data Initiative is important to commercial, research, and academic enterprises as it:

  1. Sets defacto minimum practices likely to be applied in legal, regulatory, and standards assessments and evaluations comparing enterprise guidelines, practices, and actions for “reasonable”

  2. Establishes the scope of requirements for infrastructure, platforms, toolchains, and software functions that must address all aspects of data security/integrity, access controls/logging, and applications usage for data values/collections and metadata(models)

  3. Covers existing, identified data gaps, and future data – using “gap analysis” applied to existing and in-process data creation, collection, and usage

  4. Specifically links to applications and requirements touched in manufacturing, research, and uses in subject matter areas as diverse as food, biobased products, medicine, land use management, and environmental climate change


EkaLore has long standing work in the areas addressed by the Data Initiative and can provide deeper analysis, insight, and enterprise-specific guidance on request.


Reach us at eliot.axelrod@ekalore.com for further insights on this topic.

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