FDA Meeting: Patient Engagement Advisory Committee

The Food and Drug Administration (FDA) will hold a meeting of its Patient Engagement Advisory Committee. The general function of the Committee is to provide advice to the Commissioner, or designee, on complex issues relating to medical devices, the regulation of devices, and their use by patients. 

The Committee will discuss and make recommendations on the topic “Cybersecurity in Medical Devices: Communication That Empowers Patients.” Medical devices are increasingly connected to the internet, hospital networks, and other medical devices to provide features that improve healthcare and increase the ability of healthcare providers to treat patients. These same features may also increase cybersecurity risks. Preserving the benefit of these devices requires continuous vigilance as well as timely and effective communication to medical device users about evolving cybersecurity risks. The recommendations provided by the committee will address which factors should be considered by FDA and industry when communicating cybersecurity risks to patients and to the public, including but not limited to the content, phrasing, the methods used to disseminate the message and the timing of that communication. The recommendations will also address concerns patients have about changes to their devices to reduce cybersecurity risks as well as the role of other stakeholders such as healthcare providers in communicating cybersecurity risks to patients.

Members of the public may attend in person. More information is available at this Federal Register notice.

DOC Meeting: National Telecommunications and Information Administration, Multistakeholder Process on Promoting Software Component Transparency

The Department of Commerce (DOC), National Telecommunications and Information Administration (NTIA), will convene a meeting of a multistakeholder process on promoting software component transparency. This process focuses on promoting software component transparency. Most modern software is not written completely from scratch, but includes existing components, modules, and libraries from the open source and commercial software world. Modern development practices such as code reuse, and a dynamic IT marketplace with acquisitions and mergers, make it challenging to track the use of software components. The Internet of Things compounds this phenomenon, as new organizations, enterprises, and innovators take on the role of software developer to add “smart” features or connectivity to their products. While the majority of libraries and components do not have known vulnerabilities, many do, and the sheer quantity of software means that some software products ship with vulnerable or out-of-date components.

The first meeting of this multistakeholder process was held on July 19, 2018, in Washington, DC. Stakeholders presented multiple perspectives, and identified several inter-related work streams: Understanding the Problem, Use Cases and State of Practice, Standards and Formats, and Healthcare Proof of Concept. Since then, stakeholders have been discussing key issues and developing products such as guidance documents. NTIA acts as the convener, but stakeholders drive the outcomes. Success of the process will be evaluated by the extent to which broader findings on software component transparency are implemented across the ecosystem.

The main objectives of the September 5, 2019, meeting are to review drafts provided by the working groups, discuss how they complement each other, and hear feedback from the broader stakeholder community. Stakeholders will also identify next steps in this effort, how progress can be made on extending the basic model, collecting tooling, and promoting awareness and adoption of stakeholder work.

Members of the public may attend in person. More information is available at this Federal Register notice.

DOE Comment Deadline: Basic Research Initiative for Microelectronics

The Department of Energy (DOE), Office of Science (DOE-SC), is seeking information and comments around its considered launch of a multi-program basic research initiative in support of microelectronics and semiconductor sectors. The participating program offices in DOE-SC invite interested parties to provide input on the topical areas, innovation mechanisms, impact, and potential collaborations, including public-private partnerships, that could be implemented under this initiative. DOE-SC is particularly interested in ways in which unique DOE facilities, expertise and capabilities can be leveraged to support US continued global innovation and leadership in this field.

For decades DOE-SC has been at the leading edge of microelectronics and semiconductor-based technology innovations, both as a consumer and as an engine of scientific understanding that has enabled many of the technological breakthroughs adopted by industry. Since the invention of the integrated circuit in 1960, advances in microelectronics have followed Moore's Law and other scaling laws, leading to circuit density and device performance improvements of 109 over this time period. In turn, strong commercial demand fueled the pace of scaling, and assured that the needs of DOE-SC facilities were met.

Today, the end of Moore's Law, along with the emergence of new computing workloads, new materials and devices, and new models of computation, have resulted in an unprecedented need and opportunity to “redesign” the innovation process. As highlighted in the SC-sponsored Basic Research Needs for Microelectronics workshop, to enable continued advances in computing and power technologies, a fundamental rethinking is needed of the science behind the materials and chemistry, physics, synthesis and fabrication technologies, architectures, algorithms, modeling, simulation, and design software tools. Could we replace the historical roadmaps with co-design collaborations among software developers, computer architects, circuit designers, device physicists, materials scientists, and chemists to guide a new R&D strategy? The outcome of such an “end-to-end co-design framework” could fundamentally reshape future high performance computing, sensing, data analytics, artificial intelligence, power conversion and control, and other electronics-intensive applications.

DOE-SC supports robust basic research portfolios and scientific user facilities for chemical, physical, mathematical, computational sciences, and modeling/simulation. DOE-SC is poised at the convergence of these scientific disciplines, in a unique position to play a critical role in the advancement of microelectronic technologies over the coming decades. In addition, the success and impact of DOE-SC facilities (e.g. high-performance computers, x-ray and neutron scattering centers, and high energy physics experiments) will be dependent upon the resultant capabilities in computing, sensing, power, and communications.

DOE-SC is considering the launch of a basic research Microelectronics R&D initiative with emphasis on the following broad areas:

  • Materials, chemistry, surface science, and plasma science/technology
  • Device physics and circuits
  • Component integration, architecture, and algorithms
  • Next-generation tools for synthesis, fabrication, and characterization

Investments in these areas will provide foundational support for U.S. leadership in key technology growth areas, including the following:

  • Memory and Reconfigurable Systems
  • Machine Learning and Artificial Intelligence
  • Edge Computing, Sensors, and the Internet of Things
  • Power Electronics, the Electricity Grid, and Cyber Physical Systems
  • Energy Efficiency of Computation and Packaging

Members of the public may submit comments online at More information is available at this Federal Register notice.

FMCSA Comment Deadline: Safe Integration of Automated Driving Systems-Equipped Commercial Motor Vehicles

The Federal Motor Carrier Safety Administration (FMCSA) requests public comment on an advance notice of proposed rulemaking (ANPRM) about Federal Motor Carrier Safety Regulations that may need to be amended, revised, or eliminated to facilitate the safe introduction of automated driving systems (ADS)-equipped commercial motor vehicles onto our Nation's roadways. In approaching the task of adapting its regulations to accommodate automated vehicle technologies, FMCSA is considering changes to its rules to account for significant differences between human operators and ADS.

Of note, on May 31, 2019 (84 FR 25229), the FMCSA clarified that the deadline for comments on this ANPRM would be July 29, 2019, rather than the originally-published August 26, 2019. On July 31, 2019 (84 FR 37228), the FMCSA extended the comment deadline to August 28, 2019.

Members of the public may submit comments online at, or via mail or fax. More information is available at this Federal Register notice.

CDC Comment Deadline: Mining Automation and Safety Research Prioritization

The National Institute for Occupational Safety and Health (NIOSH) of the Centers for Disease Control and Prevention (CDC) has recently established a research program to address the rapidly expanding area of automation and associated technologies in mining. NIOSH is requesting information to inform the prioritization of research to be undertaken by the institute's Mining Program. NIOSH reopening its opportunity to provide input on priority gaps in knowledge regarding the safety and health implications of humans working with automated equipment and associated technologies in mining, with an emphasis on worker safety and health research in which NIOSH has the comparative advantage, and is unlikely to be undertaken by other federal agencies, academia, or the private sector.

Of note, the original request for comment closed on May 17, 2019, but on June 24, 2019, NIOSH reopened and extended the comment deadline to August 23, 2019.

The mining industry has been undergoing significant changes as companies look to adopt automation technologies to decrease costs and increase efficiency and, according to some companies, improve safety. These new technologies include automated mobile equipment, robotics, teleoperation, wireless communications and sensing systems, wearable sensors and computers, virtual and augmented reality, and data analytics. Surface iron ore mines in Western Australia are moving rapidly to adopt automation technologies, and they appear to be the closest in achieving completely autonomous mining. In U.S. mines, the adoption of automation technology is gaining momentum, with some of the first automation having been applied to processing facilities, drilling equipment, underground coal mine longwalls, and now pilot projects with automated haulage trucks and loaders.

To prepare for expanded use of automation technologies, NIOSH seeks to both proactively address worker health and safety challenges that may be associated with automation, as well as leverage new technologies to improve miner health and safety. To understand the state of automation technologies, their implementation in the United States, and the health and safety concerns associated with the technology, NIOSH seeks public input on the following questions:

  1. To what extent will automation and associated technologies be implemented in mining and in what timeframe?
  2. What are the related health and safety concerns with automation and associated technologies in mining?
  3. What gaps exist in occupational health and safety research related to automation and associated technologies?

While the above questions have priority, NIOSH also seeks public comment on the state of the technology and the health and safety concerns associated with the following specific topics related to automation:

  1. What are the major safety concerns associated with humans working near or interacting with automated mining equipment? Have other organizations addressed the safety concerns associated with humans working near or interacting with automated mining equipment? If yes, please provide a description.
  2. What research has been conducted, or approaches taken, to address the potential for human cognitive processing confusion, misunderstanding, and task or information overload associated with monitoring or controlling automated mining equipment or other monitoring systems (e.g., fleet management, environmental monitoring, safety systems, health care systems)?
  3. What is the state of the art for display methodologies and technologies to provide mine personnel and equipment operators with information on operational status, location, and sensory and environmental feedback from automated mining equipment or systems?
  4. What sensor technology improvements are needed to ensure the safety of humans working on or near automated equipment?
  5. How are existing methods of big data analytics applied to automated mining equipment or systems? Are there health and safety benefits to these applications? If yes, please describe.
  6. Are there any needed improvements to guidelines or industry standards for automated mining system safe design and operation practices? If yes, please describe.
  7. Are there any needed improvements to training materials, training protocols, and operating procedures for system safety design principles related to automated mining systems? If yes, please describe.

NIOSH is seeking feedback on the research areas identified above and on any additional knowledge gaps, ideas, innovations, or practice improvements not addressed by these research areas, as well as feedback on how the research areas should be prioritized. NIOSH is especially interested in any creative and new ideas as they relate to protecting the health and safety of miners today and in the future. When possible, NIOSH asks that commenters provide data and citations of relevant research to justify their comments. NIOSH is also seeking key scientific articles addressing worker safety and health related to mining automation that could inform our research activities.

Comments may be submitted online at or by mail. For more information regarding this comment deadline, please see this Federal Register notice.

OSHA Comment Deadline: Control of Hazardous Energy (Lockout/Tagout)

The Occupational Safety and Health Administration (OSHA) seeks public comment on its proposal to modernize the control of hazardous energy (Lockout/Tagout) standard. The standard's purpose is to protect workers from the dangers of hazardous energy. This comment opportunity seeks information regarding two areas where modernizing the Lockout/Tagout standard might better promote worker safety without additional burdens to employers: control circuit type devices and robotics.

OSHA's Lockout/Tagout standard currently requires that all sources of energy, including energy stored in the machine itself, be controlled during servicing and maintenance of machines and equipment using an energy-isolating device (EID). Control circuit type devices are specifically excluded from OSHA's definition of an EID and are thus not a compliant method of controlling hazardous energy during service and maintenance activities. But technological advances since the standard was issued in 1989 suggest that, at least in some circumstances, control circuit type devices may be at least as safe as EIDs. OSHA requests information, data, and comments that would assist the agency in determining under what conditions control circuit type devices could safely be used for the control of hazardous energy.

OSHA may also consider changes to the Lockout/Tagout standard that address hazardous energy control for new robotics technologies. Employers are increasingly using robots and robotic components in their workplaces. OSHA would like to know more about what hazards and benefits this presents with respect to control of hazardous energy, safeguards that can be used, increased efficiencies that result, and any other information related to ensuring employee safety in interfacing with robots. OSHA will use the information received in response to this request for information to determine what action, if any, it may take to reduce regulatory burdens while maintaining worker safety.

Members of the public may submit comments online at, or by mail or fax. More information is available at this Federal Register notice.