compliance news
U.S. House Proposes Removal of Private Use Land Restrictions for Amateur Radio
Members of the U.S. House of Representatives have reintroduced legislation that would remove certain private land use restrictions that apply to the installation or use of amateur radio antennas.

According to a posting on the ARRL website, the legislation, H.R. 4006, also known as the “Amateur Radio Emergency Preparedness Act,” is intended to support the ability of amateur radio operators to install “reasonable” antennas and antenna structures on property or land that they own or control.

Congressman Bill Johnson (OH), one of the sponsors of the proposed legislation, noted that passage of the bill would help “remove barriers to disaster and emergency communications and training,” as well as “promote education in STEM subjects related to critically needed wireless technology.”

The bill is backed by the ARRL, the National Association for Amateur Radio.

New Thermal Management Process Could Double Life-Span of EV Batteries
An Israeli company is pioneering the development and use of a battery system for electric vehicles (EVs) that can offer both increased safety and extended battery life.

According to a posting on the yahoo!finance website, the company, Carrar, has developed a two-phase battery thermal management solution that minimizes the risk of thermal runaway, thereby significantly increasing battery safety. At the same time, by optimizing the operating temperature range of the battery, the company’s innovative thermal management technology can help to double the effective battery life, thereby reducing the environmental impact of battery waste.

Carrar has recently announced a partnership with Rochling Automotive, a German-based supplier of customized plastic solutions, to develop a fully-sealed module for EV batteries that incorporates both Carrar’s advanced thermal management technology and Rochling’s lightweight plastic solutions.

FDA Releases Final Guidance on Pre-Market Submissions for Medical Device Software Functions
The U.S. Food and Drug Administration (FDA) has published a final version of its Guidance on the recommended documentation on software functions in medical devices to be included in premarket submissions for FDA review.

The Guidance, “Content of Premarket Submissions for Device Software Functions,” is intended to cover a variety of software-driven functions available in today’s advanced medical devices, including firmware, software accessories, and software-only functions, such as functions intended to be operated on commercial OTS computing platforms. The Guidance does not apply to automated manufacturing or quality system software.

According to the Guidance, specific areas of software functionality that should be documented in premarket submissions include:

  • Software description
  • Risk management file
  • Software requirement specifications
  • System and software architecture design
  • Software design specifications
  • Software development, configuration management, and maintenance practices
  • Software testing as part of verification and validation
  • Software version history
  • Unresolved software anomalies
The updated Final Guidance supersedes the original version of the Guidance issued in May 2005.

As a reminder, Guidance documents issued by the FDA are intended only to represent the current thinking of the agency and are not binding on either the FDA or the public.

Digital illustrative representation of an individual's head & upper neck area with artificial intelligence (AI) elements all around such as numerals 0 and 1 plus tick mark as well as circular/line shapes
EU Moves Toward Regulation of AI
The draft law restricts use of artifical intelligence in the European Union
In a major regulatory development, the European Parliament has passed a draft law that would place restrictions on the use of artificial intelligence (AI) in the European Union (EU).

According to an article posted on the website of the New York Times, the Parliament has voted to adopt a revised version of a Proposal from the EU Commission that would help to ensure that AI technologies and systems are “safe, transparent, traceable, non-discriminatory, and environmentally friendly.” The final version of the draft A.I. Act passed by Parliament will now be negotiated between the Parliament, the Commission, and the Council of the European Union, with a final agreement expected to be reached by year’s end.

The Parliament’s revision of the Commission’s Proposal includes bans on “intrusive and discriminatory uses of AI systems,” including certain biometric identification systems, the scraping of biometric data from social media to create facial recognition databases, and biometric categorization systems using sensitive characteristics, such as gender, race, ethnicity, religion, or political orientation.

Policymakers in other countries have also initiated discussions on potential steps to control the use and control of AI technologies. But the actions by the EU represent the most significant advancement of potential AI regulatory controls to date.

Share this story: