Collaborating Authors

Good Documentation Practice Guideline


Good Documentation Practices are the soul of many regulated industries. The FDA, like all other regulatory agencies, makes GDP a central element of its regulations, and bases it on the principle of evidence. For the FDA and other regulatory agencies across the world, what is not documented is nonexistent.

NBN seeks regulatory amendment to support fibre, copper, HFC network mix


The Australian Competition and Consumer Commission (ACCC) has published the proposed variations submitted by the National Broadband Network (NBN) company to its Special Access Undertaking (SAU) in order to take into account the multi-technology mix. The SAU, originally submitted to the ACCC in 2013, governs the pricing and regulatory terms facing the NBN until 2040. "The SAU provides an overarching framework for the regulation of access to the NBN," ACCC Commissioner Cristina Cifuentes said. "The SAU currently does not capture the additional network technologies that NBN Co has introduced since the SAU was accepted. NBN Co is now seeking to address this through the SAU variation."

Artificial Intelligence Principles Issued by White House


Federal agencies and the private sector would have new guidelines for developing artificial intelligence technologies, such as AI-powered medical devices and autonomous vehicles and drones, under a draft set of principles from the Trump administration. The 10 principles released Tuesday by the White House Office of Science and Technology Policy would direct federal agencies to develop consistent policies on AI technology, including soliciting public engagement from academics, nonprofits, industry and civil society, while also ensuring the products are safe for the public and don't discriminate. "We believe that consistency is really, really important and it sends a very important and very powerful message to industry so that they actually have clarity on the way that they should be thinking about bringing forth products which fall under some sort of regulatory oversight," Michael Kratsios, U.S. chief technology officer, said on a press call yesterday. "With this consistency, we think we can spur greater innovation around the country, and we can also help all of our regulators across all of our agencies be more consistent and be more aware of what they need to do to promulgate regulations at a good clip and speed," Kratsios added. Kratsios and Lynne Parker, the U.S. deputy chief technology officer, are expected to speak further about the the AI regulatory principles during separate panels on Wednesday at CES, the year's largest tech show, taking place in Las Vegas.

Convergent regulatory evolution and loss of flight in paleognathous birds


A core question in evolutionary biology is whether convergent phenotypic evolution is driven by convergent molecular changes in proteins or regulatory regions. We combined phylogenomic, developmental, and epigenomic analysis of 11 new genomes of paleognathous birds, including an extinct moa, to show that convergent evolution of regulatory regions, more so than protein-coding genes, is prevalent among developmental pathways associated with independent losses of flight. A Bayesian analysis of 284,001 conserved noncoding elements, 60,665 of which are corroborated as enhancers by open chromatin states during development, identified 2355 independent accelerations along lineages of flightless paleognaths, with functional consequences for driving gene expression in the developing forelimb. Our results suggest that the genomic landscape associated with morphological convergence in ratites has a substantial shared regulatory component.

Blockchain Australia asks for 'nimble' regulatory regime to help local DLT industry


Blockchain Australia, the industry body representing local businesses and individuals participating in the nascent technology, has asked for government and regulatory support in building a thriving blockchain ecosystem. The body describes itself as encouraging the "responsible adoption of blockchain technology by the government, industry, education, and startup sectors across Australia as a means to drive innovation and create jobs". "The development of blockchain technology will enable business process transformation, impacting markets in almost every sector of the global economy," it wrote in a submission [PDF] to the Senate Select Committee on Financial Technology and Regulatory Technology in its second round of reviewing the potential of fintech and regtech down under. Round one: Sweeping change: Fintech committee offers'quick wins' fix to Australian ecosystem But in order to execute on its mission, Blockchain Australia said it needs a little bit of wiggle room from regulators. According to the organisation, regulatory uncertainty is a "persistent and recurring theme" in blockchain and distributed ledger technology (DLT) discussions.