AI News, AI Update: White House Issues 10 Principles for Artificial Intelligence ... artificial intelligence

Artificial Intelligence and Machine Learning in Software as a Medical Device

Artificial intelligence and machine learning technologies have the potential to transform health care by deriving new and important insights from the vast amount of data generated during the delivery of health care every day.

real-world examples of artificial intelligence and machine learning technologies include: Adaptive artificial intelligence and machine learning technologies differ from other software as a medical device (SaMD) in that they have the potential to adapt and optimize device performance in real-time to continuously improve health care for patients.

The ideas described in the discussion paper leverage practices from our current premarket programs and rely on IMDRF’s risk categorization principles, the FDA’s benefit-risk framework, risk management principles described in the software modifications guidance, and the organization-based total product lifecycle approach (also envisioned in the Digital Health Software Precertification (Pre-Cert) Program).

This plan would include the types of anticipated modifications—referred to as the “Software as a Medical Device Pre-Specifications”—and the associated methodology being used to implement those changes in a controlled manner that manages risks to patients —referred to as the “Algorithm Change Protocol.” In this approach, the FDA would expect a commitment from manufacturers on transparency and real-world performance monitoring for artificial intelligence and machine learning-based software as a medical device, as well as periodic updates to the FDA on what changes were implemented as part of the approved pre-specifications and the algorithm change protocol.

U.S. AI and IoT Quarterly Legislative Update: Fourth Quarter 2019 Blog Inside Tech Media

U.S. federal policymakers continued to focus on artificial intelligence (“AI”) and the Internet of Things (“IoT”) in the fourth quarter of 2019, including by introducing substantive bills that would regulate the use of such technology and by supporting bills aimed at further study of how such technology may impact different sectors.

Near the end of this quarter, the following bills were also introduced in this same area: In addition to Congress’s continued focus on energy and infrastructure, the following measures were also introduced in this quarter: Connected and Autonomous Vehicles Congress did not roll out comprehensive CAV legislation in 2019, but bipartisan, bicameral efforts to introduce such a bill are reportedly underway.

In the fourth quarter of 2019, federal lawmakers continued seeking stakeholder input on the testing and deployment of CAVs, in an effort to introduce legislation that builds from and improves upon the SELF DRIVE Act (House) and AV START (Senate), both of which did not pass in 2018 amidst concerns around safety and security.

In the coming year, further efforts to introduce comprehensive federal CAV legislation will likely continue to focus on safety measures, as well as reconciling stakeholder perspectives on cybersecurity, data privacy, federal preemption, and arbitration clauses.

In December, the FCC issued a notice of proposed rulemaking seeking to reallocate the 5.9 GHz band for unlicensed operations and Cellular Vehicle to Everything (“C-V2X”) technologies, while potentially preserving portions of the band for existing dedicated short-range communications (“DSRC”) technologies.

How Credible Are the White House�s AI Regulation Principles?

Considering the degree of alarm that AI has triggered in the general population, we can expect a deeper dose of laws and regulations governing how the technology is deployed, used, and managed.

They also advocate cross-agency consistency and public participation in the rulemaking process, require security, transparency, and fairness in how AI is used, and call for flexible regulatory updates to adapt to technological advances.

Under Trump, private business is being given free regulatory rein -- without interference from pesky scientific authorities -- to heat the planet, pollute our environment, and endanger the safety of workers, consumers, and everybody else.

in the rulemaking process without a shred of cynicism, we need to ask who exactly would determine what constitutes such evidence for the purpose of framing specific agency regulations that govern AI.

More than that, scientific professionals -- including the data scientists most competent to advise on AI regulations -- have been told in no uncertain terms that their skills are no longer needed under this administration and that it would be best for them to leave public service entirely.

If you’re a US taxpayer, you best believe that the people remaining at the federal level to adjudicate what constitutes credible scientific evidence will be some unholy alliance of pseudoscientific quacks and ideological hacks.

The administration recently instituted an export ban that forbids US companies from selling software abroad that uses AI to analyze satellite imagery without a license.

This ban is quite clearly intended to deny China, in particular, access to such technology, though they’ve obviously made huge investments domestically and probably can get by without US-developed AI software for this use case.

No matter how much merit these proposed AI regulation principles might possess in the abstract, they’re an obvious ploy for the Trump administration to retaliate against the left-leaning Silicon Valley companies that are driving the AI revolution.

This executive orderthat puts forth a high-level strategy guiding AI development within the US but includes no new federal funding to give the initiative a chance of succeeding.

Let’s hope that whatever administration follows Trump actually institutes responsible regulation of AI at the federal level, while funding the R&D needed to develop credible tooling and approaches to manage AI responsibly wherever it touches our lives.

Issue Spotlight

The Centers for Disease Control and Prevention (CDC) is in the process of updating its guidelines for prescribing opioids for treatment of chronic pain, which were issued in 2016.

Now the CDC has turned to its Board of Scientific Counselors to form a new Opioid Workgroup to provide expert input on an update to the guidelines.The Opioid Workgroup will be tasked with: More information about the medical specialists and others who the CDC is seeking to have represented on the workgroup is available here.

Clinicians in small practices (including those in rural locations), health professional shortage areas, and medically underserved areas may request technical assistance from organizations that can provide no-cost support.

In response to AMA's strong advocacy for increasing the low-volume threshold and ensuring a level playing field for independent and small practices, participation rates among small and rural practices increased.

The principles also appear to encourage restraint by regulators when it comes to AI, urging agencies to carefully weigh the costs and benefits of new regulation prior to implementing new oversight structures.

The AMA is carefully monitoring health care AI regulatory activity and is committed to ensuring that regulation of AI deployed into clinical practice is appropriate to ensure patient safety.

The workshop featured presentations by a number of FTC staff and legal scholars, with the aim of facilitating discussion around the impacts of these clauses on competition and consumer protection.

In response to a letter from the AMA outlining concerns regarding the Appropriate Use Criteria (AUC) program testing year, CMS has added a notice on its AUC webpage explicitly stating that 2020 is a testing period.

The legislation would have given APNs full signatory authority, allowing them to execute any document that requires a physician signature by law and would have allowed APNs to prescribe medications without any physician oversight.

This win keeps important safety protocols in place for advanced practice nurses to work with physicians as part of the patient-focused health care team.

Evans' request for a damages-only retrial is a relief to physicians who told the state's high court that retrial only focused on the damages would open up physicians and hospitals to increased liability.

'Allowing a separate jury to hear a damages-only trial has been proven to lead to excessive damages and injustice,' theLitigation Center of the American Medical Association and State Medical Societiesand the Medical Association of Georgia tell the court in anamicus briefthey filed jointly in the case,Evans v.

Instead, the court vacated the Court of Appeals of Georgia ruling that concluded that the jury award 'shocked the conscience' by not awarding damages for pain and suffering and that Evans was entitled to a retrial that determined both liability and damages.

The high court ruling, aligning with the Litigation Center brief, says the lower court 'could not substitute its judgment for that of the trial court on the fact-based question of whether the damages awarded were within the range authorized by a preponderance of the evidence.'

Justices on the high court wrote that 'the Court of Appeals instead should have limited its review to whether the trial court, who saw the witnesses and heard the testimony, abused its discretion in denying the motion for a new trial.'

Medicaid Services (CMS) has published a list of nearly 3,000 physicians who are eligible to receive alternative payment model (APM) incentive payments based on their APM participation in 2017, but whom CMS has been unable to find in order to make the payments to them.

Physicians whose practices participated in APMs during 2017 but who have not yet received their lump sum incentive payment should review the list and follow the instructions for providing contact and banking information to CMS to claim these payments.

More than 200 physicians and other individuals participated in a live webinar on Jan. 6 to hear directly from the CMS staff implementing the new Primary Care First alternative payment model and have their questions answered before the Jan. 22 application deadline.

The National Advocacy Conference gives you the opportunity to connect with industry experts, political insiders and members of Congress about current federal efforts to improve health care in addition to visiting Capitol Hill to advocate on crucial health care issues affecting you and your patients.

Government officials, first responders, law enforcement personnel, clinicians, physicians, nurses, educators, public health and prevention officials and families and people in recovery are represented.