A myriad of laws, rules, and regulations are worthy of consideration for any new and innovative technology, and even more so for one as broad ranging and comprehensive as the Digital Twin ecosystem. A technology like this has the contradiction of open versus proprietary, and all the hybrids in between, because it is in the early stages of its evolution that, in many respects, relies on a combination of existing technologies and innovations. From a legal standpoint, we consider intellectual property rights, including patent, copyright, and trade secret protection, and balancing those rights with the benefits and protections available under contract law. The wide applicability of the Digital Twin to various technologies and fields, such as healthcare, finance, education, aviation, power plants, nuclear reactors, any many more, gives rise to regulatory considerations and ethical concerns. The Digital Twin ecosystem, as applied in these areas and more, requires the collection, processing, generation, and transmission of data subject to regulatory requirements involving privacy and cybersecurity issues, as well as ethical concerns requiring careful consideration of potential bias, trustworthiness, and transparency in the technology used.
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The importance of these considerations was highlighted in the current draft publication from the National Institute of Standards and Technology (NIST), NISTIR 8356, entitled “Considerations for Digital Twin Technology and Emerging Standards” (April 2021), p. 4 (“Whether or not these developments catalyze Digital Twin technology into widespread use may depend upon work in standards development. Currently most IoT systems, simulation and modeling software, and VR and AR systems exist in stovepipe proprietary systems. It is possible to combine them, but it takes significant work to integrate them. Much of the work in the emerging Digital Twin area is in the creation of protocols and standards to enable plug and play integration. The idea is to mix and match and be able to use any viewer with any Digital Twin simulator and modeler along with any sensing device. The idea is to be able to load any Digital Twin computer file into a Digital Twin system and have it function regardless of what is being modeled. These are lofty goals for the emerging Digital Twin community; their success in standards may largely determine the extent to which the technology is used.”).
See Bilski v. Kappos, 561 U.S. 593, 611 (2010; and Diamond v. Chakrabarty, 447 U.S. 303, 309 (1980) (“The Court’s precedents provide three specific exceptions to § 101’s broad patent-eligibility principles: ‘laws of nature, physical phenomena, and abstract ideas.’”).
There are three categories of subject matter that are considered abstract ideas: mathematical concepts, certain methods of organizing human activity, and mental processes. Only concepts that fall into those groupings can be rejected as “abstract ideas.”
The U.S. Patent and Trademark office provides several examples of inventions and corresponding claims that are illustrative of the analysis that is made to determine subject matter eligibility. These specific examples provide good guidance, at least under the current legal standard as applied. Seehttps://www.uspto.gov/sites/default/files/documents/101_examples_37to42_20190107.pdf (“Example 37: Relocation of Icons on a Graphical User Interface; Example 38: Simulating an Analog Audio Mixer; Example 39: Method for Training a Neural Network for Facial Detection; Example 40: Adaptive Monitoring of Network Traffic Data; Example 41: Cryptographic Communications; and Example 42: Method for Transmission of Notifications When Medical Records Are Updated.”). The European Patent Office has also provided recent guidance on these issues. Seehttps://www.epo.org/law-practice/case-law-appeals/communications/2021/20210310.html (PO G 1/19 decision addressing simulation invention for movement through a building.).