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192 IoT Applications — Value Creation for Industry
3.7.1.5 Legal information flows
Legal issues around data exchange can be divided into two separate concerns,
one is the question of jurisdiction over data, and secondly, within that context,
what party(s) own the data. In the US for example, despite a common
interest in ensuring efficient oversight and promoting safe and environmentally
friendly products, the FDA has not been active in developing national
standards on transportation and drug packaging, Unit of Use labelling and
sustainability guidelines and has instead relied on local and state governments
to regulate material composition, reuse, recycling, and recovery of packaging
through legislation and ordinance. By contrast EU Directive 94/62/EC, “Packaging
and Packaging Waste Directive” (PPWD) and the associated ISO/TC
122/SC 4, “Packaging and environment” are driving packaging changes in that
jurisdiction.
Even where there are no jurisdictional issues, “who owns the data” is a
challenge issue for industry stakeholders. Under current US healthcare legislation
a patient has rights to access their records, but who owns this data,
the doctor, the hospital, the software or hardware/services provider? Developing
secure marketplace mechanisms for the exchange of patient data was the
topic of one session at the PDA/FDA Pharmaceutical Supply Chain Integrity
Conference [28 Miles, 2012].
3.7.1.6 Finance flows
Data is a core asset of every company and a strategic resource that can be
harvested with advances in AIDC technologies. Every step in the development,
clinical trials, manufacturing, distribution and service delivery of
a biologics product involves massive amounts of data. Extensive industry
guidelines and best practices are established for the use of this information
in specific contexts such as quality control or product authentication. Good
Manufacturing Practice (GMP) production and testing practices ensure quality
products.
A parallel assessment of data asset values, liabilities and exchange
mechanisms for these data assets is warranted in light of pharmaceutical development,
technology transfer, commercial manufacturing and product discontinuation
processes. The value of products as they move through the supply