The US Department of Transportation’s National Highway Traffic Safety Administration recently released A Vision for Safety 2.0, an update to its prior guidance on automated driving systems. The new guidance adopts a voluntary, flexible approach to regulation of automated driving systems and clarifies that it alone, and not the states, is responsible for regulating the safety design and performance aspects of such systems.
Although the incorporation of technology into human endeavours—commercial, political and personal—is a normal component of technological innovation, the advent of artificial intelligence technology is producing significant challenges we have not felt or understood with earlier innovations. For many years, for example, there has been speculation, research and public debate about the impact of the internet, the functioning of search engines, and online advertising techniques on commercial and political decisions.
The alleged “hacking” of the 2016 US presidential election, and the concerns about such activities in the 2017 European elections, will only heighten the interweaving discussions on free speech, national sovereignty, cyber security and the nature of privacy.
The use of artificial intelligence and machine-learning technologies has only added to the list of issues and areas of concern. The consequences of automobile accidents involving “self-driving” technologies, the “flash crashes” on securities markets due to algorithmic trading, and bias in systems designed to determine benefit eligibility, are requiring us to consider what happens when we defer judgment to machines, and highlighting the importance of quality in data sets and sensors.
The government is continuing to ask for more help from the private sector to defend against cyber attacks. The National Infrastructure Advisory Council (NIAC) recently published a report discussing current cyber threats and urging private companies and executives to join forces with the government to better address those threats. The report proposes “public-private and company-to-company information sharing of cyber threats at network speed,” among other things discussed here.
On 6 August 2017, the UK government released ‘The Key Principles of Vehicle Cyber Security for Connected and Automated Vehicles’, guidance aimed at ensuring minimum cybersecurity protections for consumers in the manufacture and operation of connected and automated vehicles.
Connected and automated vehicles fall into the category of so-called ‘smart cars’. Connected vehicles have gained, and will continue to gain, adoption in the market and, indeed, are expected to make up more than half of new vehicles by 2020. Such cars have the ability through the use of various technologies to communicate with the driver, other cars, application providers, traffic infrastructure and the Cloud. Automated vehicles, also known as autonomous vehicles, include self-driving features that allow the vehicle to control key functions–like observing the vehicle’s environment, steering, acceleration, parking, and lane changes–that traditionally have been performed by a human driver. Consumers in certain markets have been able to purchase vehicles with certain autonomous driving features for the past few years, and vehicle manufacturers have announced plans to enable vehicles to be fully self-driving under certain conditions, in the near future.
The Enhanced Nurse Licensure Compact (Compact) has now been adopted by 26 states, which means the Compact will be taking effect on January 19, 2018. Nurses who seek to practice telemedicine and deliver in-person care across state lines and who meet the Compact’s licensure requirements in these states will have one less obstacle to overcome going forward.
The Compact is an updated version of the original compact allows for registered nurses (RNs) and licensed practical/vocational nurses (LPN/VNs) to have one multistate license, which will enable them to practice nursing in person or via technology (e.g., videconference) in both their home state, as well as the other Compact states. Development and implementation of the Compact was not an easy feat, given the need for alignment of licensing standards across the Compact states, including federal and state fingerprint-based criminal background checks.
The 26 states participating in the Compact as of today are Arizona, Arkansas, Delaware, Florida, Georgia, Idaho, Iowa, Kentucky, Maine, Maryland, Mississippi, Missouri, Montana, Nebraska, New Hampshire, North Carolina, North Dakota, Oklahoma, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, West Virginia and Wyoming.
For more information about the Compact, please visit: https://www.ncsbn.org/11070.htm.
Last Tuesday afternoon, the US Food and Drug Administration (FDA) held a webinar to outline a recently-published Digital Health Innovation Action Plan (Plan). In the Plan, the agency recognized that the traditional regulatory approach toward moderate and high risk medical devices is not well suited for the fast-paced, iterative design, development and type of validation used for digital health software products today. Going forward, the agency plans to explore an innovative approach to regulating these types of products. The approach contains three primary prongs: (1) the issuance of new guidance, (2) the Digital Health Software Precertification Program and (3) an internal expansion of FDA’s digital health capabilities.
The webinar was presented by Bakul Patel, Associate Director for Digital Health at FDA. At least 905 attendees logged in to the webinar. (more…)
New technologies and the expansion of the Internet of Things have allowed children of this generation to experience seamless interactive technologies through microphones, GPS devices, speech recognition, sensors, cameras and other technological capabilities. These advancements create new markets for entertainment and education alike and, in the process, collect endless amounts of data from children–from their names and locations to their likes/dislikes and innermost thoughts.
The collection of data through this Internet of Toys is on the tongues of regulators and law enforcement, who are warning parents to be wary when purchasing internet-connected toys and other devices for children. These warnings also extend to connected toy makers, urging companies to comply with children’s privacy rules and signaling that focused enforcement is forthcoming.
Federal Trade Commission Makes Clear That Connected Toy Makers Must Comply with COPPA
On June 21 2017, the Federal Trade Commission (FTC) updated its guidance for companies required to comply with the Children’s Online Privacy and Protection Act (COPPA) to ensure those companies implement key protections with respect to Internet-connected toys and associated services. While the FTC’s Six Step Compliance Plan for COPPA compliance is not entirely new, there are a few key updates that reflect developments in the Internet of Toys marketplace. (more…)
On May 31, 2017, the US Department of Justice announced a Settlement Agreement under which eClinicalWorks, a vendor of electronic health record software, agreed to pay $155 million and enter into a five-year Corporate Integrity Agreement to resolve allegations that it caused its customers to submit false claims for Medicare and Medicaid meaningful use payments in violation of the False Claims Act.
On May 3, 2017, the Creating Opportunities Now for Necessary and Effective Care Technologies for Health Act of 2017 (S. 1016) (CONNECT Act of 2017) was reintroduced by the same six senators who had initially introduced the legislation in early 2016 and referred to the Senate Committee on Finance. As we previously reported on February 29, 2016, this iteration of the proposed bill also focuses on promoting cost savings and quality care under the Medicare program through the use of telehealth and remote patient monitoring (RPM) services, and incentivizing such digital health technologies by expanding coverage for them under the Medicare program—albeit using different terminology. Chiefly, the CONNECT Act of 2017 serves as a way to expand telehealth and RPM for Medicare beneficiaries, makes it easier for patients to connect with their health care providers and helps reduce costs for patients and providers. As with the previous iteration, the CONNECT Act of 2017 has received statements of support from over 50 organizations, including the American Medical Association, American Telemedicine Association, Healthcare Information and Management Systems Society, Connected Health Initiative, Federation of State Medical Boards, National Coalition on Health Care and an array of vendors and health systems. (more…)
The Electronic Health Records (EHR) Incentive Program run by Centers for Medicare and Medicaid Services (CMS) garnered attention again last week following the release of a report by the Office of Inspector General of the US Department of Health and Human Services (OIG) describing inappropriate payments to physicians under the program. The report follows on the heels of a high-profile settlement under the False Claims Act between the US Department of Justice and an EHR vendor related to certified electronic health record technology (CEHRT) used in the EHR Incentive Program (which we’ve previously discussed in-depth).
The OIG reviewed payments to 100 eligible professionals (EPs) who received EHR incentive payments between May 2011 and June 2014 and identified 14 inappropriate payments. OIG extrapolated the results of the review to the 250,470 total EPs who received incentive payments during that time period and estimated that CMS made approximately $729 million in inappropriate EHR incentive payments out of a total of just over $6 billion in such payments during the review period. (more…)
Subscribe
