Quartz
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Your flying car is almost here
Electric vertical takeoff aircraft, regulatory momentum, and billions in investment are pushing urban air mobility closer to reality
๐บ๐ธ ๋ฏธ๊ตญ ยท "REGULATOR" ยท ์ด 44๊ฑด
ํํฐ ๋ณด๊ธฐํ์ฌ ์ง์
50.0
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50 = ์ค๋ฆฝ
100 = ๊ธ์ ์ฐ์ธ
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Electric vertical takeoff aircraft, regulatory momentum, and billions in investment are pushing urban air mobility closer to reality
The $86 trillion perps market is finally coming onshore.
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The TV network on Thursday slammed the Federal Communications Commission, saying it was targeting its station licenses in a campaign of โunconstitutional retaliation.โ
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The National Highway Traffic Safety Administration is examining whether a rear toe link defect caused Rivian EVs to swerve across lanes and crash
The JPMorgan CEO said regulatory changes and strong profits have given the bank more flexibility to pursue deals
This story was originally published by Inside Climate News and is reproduced here as part of the Climate Desk collaboration. The warning signs were years in the making. And yet, regulators failed to heed the writing on the wall, according to Dean Naujoks. An investigator with the Potomac Riverkeeper Network, Naujoks spent three years documenting what he calls a [โฆ]
Serving businesses disfavored by bureaucrats should never have been considered a financial risk.
UK energy prices will jump by 13% from July 1 after energy regulator Ofgem on Wednesday raised the price cap as a result of higher wholesale gas prices amid the Middle East crisis. The UK has a so-called Energy Price Cap in place, which protects households from excessively high bills by capping the price that energy utility providers can pass on to them. The price cap is a limit on what suppliers can charge domestic consumers per kilowatt hour of energy used. Because of the new energy crisis created by the Iran war, energy prices in Britain willโฆ
Urged on by the White House and a reduction in regulatory oversight, crypto companies and automakers are among those that have applied for banking charters.
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The Ferrari Luce seems to be more aimed at regulatory compliance and China, putting a lot of pressure on the Jony Ive-designed EV.
Pope Leo XIV on Monday warned about the risks posed by AI in his first encyclical. In the manifesto, titled โMagnifica Humanitas,โ the pontiff wrote that policymakers must address the widespread availability of the emerging technology with โclarity to establish adequate regulatory tools capable of upholding justice and curbing the distorting effects of technological power.โ...
China's National Mine Safety Administration put Shanxi's Liushenyu mine on its high-risk list in 2024 for high gas content. On Friday, it exploded.
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Telling regulators the gambling stop is no longer sustainable, Affinity Interactive's CEO defends shutting down the last iconic Primm, Nevada, casino.
Companies reiterated plans to growing their prediction markets businesses in recent earnings calls even as a regulatory debate continues.
Patients who use mobile applications to manage medical conditions including depression and chronic pain might assume the apps have been evaluated by regulatory agencies to be safe and effective. But that isnโt necessarily the case. Most of the more than 55,000 medical apps that claim to diagnose or treat a conditionโor ones that provide clinical decision support, known as โtherapeuticโ appsโhave never been assessed by any trusted neutral bodies or regulatory agencies to evaluate them for technical soundness, ethical design, or clinical benefit. The apps often donโt comply with regional data security and privacy laws to protect peopleโs sensitive health information. Medical apps differ from traditional wellness apps, which provide users with insights into becoming healthier by, for example, tracking fitness activities, monitoring blood pressure, and analyzing sleep patterns. There is no reliable way to verify that therapeutic apps deliver the results they indicate. To help ensure such apps are credible, the IEEE Standards Association (IEEE SA) recently launched the IEEE Global Medical Mobile App Assessment and Registry. The publicly searchable directory is designed to list apps that have been vetted by experts across several criteria including technical soundness, ethical design, compliance with data security and privacy regulations, and clinical efficacy, which is evidence of a clinical benefit for the patient. โPatients, clinicians, payers, and health care systems often struggle to distinguish clinically meaningful therapeutic apps from those that are simply well-marketed,โ says IEEE Senior Member Yuri Quintana, chair of the assessment and registry program. He is chief of the clinical informatics division at Beth Israel Deaconess Medical Center, in Boston. โOur goal is to establish a standardized review method using criteria developed by experts.โ Why regulation is lacking Because the apps are intended for medical use without being part of a medical implement, they fall under the designation of software as a medical device (SaMD), according to the International Medical Device Regulators Forum. SaMD is supposed to be regulated by public health agencies such as the U.S. Food and Drug Administration, but the apps have developed and grown in popularity so quickly that regulators havenโt been able to keep up, Quintana says. Some companies have received approval, but most have not, he says. Many users are unaware of the regulatory gap, he says. โSeeing an app from a well-known company often creates the impression that it has been meaningfully vetted for safety and efficacy, even when that is not the case,โ he says. Some companies are using deceptive advertising to sell their product, he adds. Marketing materials might claim that all of a companyโs health apps are certified, even though only one app has been approved by a regulatory body to treat a particular condition. Or the verbiage might imply the company has clinical evidence proving its application works, even though the app has never been tested independently. Another concern is that updated apps arenโt being vetted, says Maria Palombini, IEEE SAโs director of health care and life sciences global practice lead. โThe original app might have received approval from a regulatory agency, but not the updated version,โ Palombini says. โThere could have been significant changes from the original.โ โNot every medical-related app triggers the same regulatory classification or review across jurisdictions,โ Quintana adds. โThat leaves a large gray zone of clinically relevant but lower-risk apps that havenโt undergone an independent assessment. The IEEE registry was created to help fill these gaps. โIEEE is the best organization to address this problem because this is fundamentally a standards, trust, interoperability, and conformity assessment challenge,โ he says. IEEE โis the worldโs largest technical professional organization, with deep expertise in developing globally recognized standards including in health care, cybersecurity, AI ethics, and interoperability.โ โThrough the IEEE Conformity Assessment Program, we already run rigorous assessment and registry programs,โ Palombini says. โOur neutral, consensus-driven, multidisciplinary approachโbringing together clinicians, regulators, developers, and ethicists without commercial biasโmakes IEEE uniquely positioned to create trustworthy global guardrails that can scale across jurisdictions and support regulatory harmonization.โ How the registry works The assessment framework was developed by a multidisciplinary group of 35 volunteer experts from 10 countries, Quintana says. The panel includes academics, AI experts, app developers, clinicians, ethicists, mental health experts, patient advocates, regulators, researchers, technologists, and those who assess safety in health care. The registry is for any app used for clinical care or therapeutics that claims to demonstrate a medical benefit. That includes apps designed for cardiology, diabetes, mental health, neurology, oncology, rehabilitation, and respiratory diseases, Quintana says. Initially, he says, the focus will be on apps that aim to treat mental health conditions, given the large number of offerings in that area and the registry committeeโs expertise. The submission of apps is voluntary. There is no government mandate that requires a company to use the IEEE registry. The products will be evaluated against about 150 consensus-based criteria across three major areas: Clinical efficacy including therapeutic effectiveness, any sustained benefits, risk management, comparison to standard care, user engagement, and real clinical value. Technical soundness including accessibility, privacy and security, error handling, interoperability, AI governance, usability, and operational quality. Ethical design including bias prevention, patient consent, data governance, conflict-of-interest transparency, responsible use of AI and large language models, and prioritization of public health benefits. IEEE charges a nonrefundable submission fee that covers the cost of the assessment plus the registryโs annual subscription for the first year. Developers first must demonstrate they are a legally established entity before they can complete the app publisher registration form and then submit documentation and attestations about the product. The IEEE review of an app is estimated to take six to eight weeks, Palombini says. The assessment results will be privately shared with the app publisher, she says, and to be listed in the registry, an app must achieve more than 85 percent compliance in each category. Upgraded apps must be submitted and reassessed, Palombini says. Similar to how users are notified when an app on their smart devices has , the registry will be notified when listed apps have a new update available, she says. Applicants who do not pass the assessment are to receive feedback explaining why. They will be given an opportunity to make changes or provide additional documentation, Palombini says. โItโs a pretty methodological process, with checks and balances,โ Quintana says. โWeโre being very transparent about the process.โ Approved apps added to the registry receive an IEEE certification badge and submission identifier, which the company can display on its website, app store listings, and marketing materials. โThe badge serves as visible proof that the app has met the independent, consensus-based assessment for clinical value, technical robustness, and ethical design,โ Quintana says. The registry will be publicly available at no cost, he says. Patients and families seeking safe, trustworthy appsโand payers and insurers evaluating reimbursement potentialโwill find the registry helpful, he says. The application website is open. The public registry page does not yet list a specific count of approved apps because assessments are ongoing. Approved apps and their unique identifiers are to be published when the initial reviews are completed. To learn more, you can watch a webinar recorded in March. The assessment framework that underpins the registry is supporting the formal recognition of IEEE P3962 Standard for Criteria Assessment Framework f