- From: ProjectParadigm-ICT-Program <metadataportals@yahoo.com>
- Date: Wed, 10 Apr 2019 05:04:59 +0000 (UTC)
- To: "owen.ambur@verizon.net" <owen.ambur@verizon.net>, "public-aikr@w3.org" <public-aikr@w3.org>
- Message-ID: <1692649619.993642.1554872699872@mail.yahoo.com>
Thanks a million for sharing this important info about SaMD. Please all check out: Artificial Intelligence and Machine Learning in Software as a Medical Device | | | Artificial Intelligence and Machine Learning in Software as a Medical Device By Center for Devices and Radiological Health | | | for the future of the single most important use of AI Milton Ponson GSM: +297 747 8280 PO Box 1154, Oranjestad Aruba, Dutch Caribbean Project Paradigm: Bringing the ICT tools for sustainable development to all stakeholders worldwide through collaborative research on applied mathematics, advanced modeling, software and standards development On Monday, April 8, 2019 1:19 PM, "owen.ambur@verizon.net" <owen.ambur@verizon.net> wrote: The content of FDA's request for comments on its proposed regulatory framework for modifications to artificial intelligence/machine learning (AI/ML)-based software as a medical device (SaMD) and proposed content for an algorithm change protocol are now available in StratML format at http://stratml.us/drybridge/index.htm#FDA Here's the comment I submitted: Consistent with the good practice set forth in section 10 of the GPRA Modernization Act (GPRAMA) and the new OPEN Government Data Act (OGDA), plans and performance reports for AI/ML-based SaMD should be published in an open, standard, machine-readable format like StratML Part 2, Performance Plans and Reports. https://www.linkedin.com/pulse/open-machine-readable-government-owen-ambur/ | http://stratml.us/references/HR4174.htm#Title_II | http://stratml.us/#Part2 Owen
Received on Wednesday, 10 April 2019 05:05:28 UTC