As the world of medical devices evolves to treat better and monitor patient health, cybersecurity remains a top priority. As per FDA guidance, “medical device security is a shared responsibility between stakeholders, including health care facilities, patients, providers, and manufacturers of medical devices.”
Read MoreRecent advances and increased application of computer-aided decision making, including artificial intelligence (AI) and machine learning (ML), have caught the attention of consumer protection organizations and regulatory agencies.
Read MoreThe FDA first drafted guidance on CDS software in 2017, but finalizing it has not been a priority for the agency since. That’s set to change next year. In late October 2021, the FDA’s Center for Devices and Radiological Health released proposed guidance documents for fiscal year 2022, with clinical decision support…
Read MoreThe Food and Drug Administration (FDA) has finally announced an updated software guidance document for Software in a Medical Device (SiMD) or Software as a Medical Device (SaMD). This document, though not legally binding as of yet, will replace the previous FDA guidance document dated May 11, 2005. In the realm of…
Read MoreThe digitization of medical records should lead to streamlined access for patients, efficiency upgrades for providers, and economic opportunity for developers. To date, these benefits exist in theory, but not in practice—due to cybersecurity concerns and the costs associated with interconnecting disparate, siloed systems, medical data is often made inaccessible to broader…
Read MoreAround the middle of August, a security research firm named Unit221B reached out to T-Mobile with some bad news—someone, or some entity, was attempting to sell reams of T-Mobile customer data on the dark web. A couple of days later, T-Mobile went public with the news that it had been massively hacked,…
Read MoreIn December 2020, the Federal Trade Commission (FTC) and 46 states plus the District of Columbia brought a lawsuit against Facebook, alleging the company was illegally maintaining a social networking monopoly via anticompetitive behavior. The goal of the lawsuit was to force Facebook to divest WhatsApp and Instagram, while also requiring the…
Read MoreQuandary Peak Research normally uses our blog page to cover the biggest and highest impact lawsuits affecting the tech sector. But this week we decided to mix it up by providing a brief breakdown of the most high-profile lawsuit taking place in the United States this summer: the prosecution of Elizabeth Holmes…
Read MoreOn July 7, Donald Trump announced he would be suing Facebook, Twitter, and Google, naming the CEOs of each company as plaintiffs in the case. The origins of the lawsuit are known to many—in the wake of the January 6 insurrection at the Capitol, each company barred Trump from posting on their…
Read MoreMassive technology companies are under more scrutiny than ever from lawmakers and the public. Google is embroiled in multiple antitrust lawsuits. Apple amended its commissions policy for smaller developers in its App Store, in what appeared to be a response to a Supreme Court-approved antitrust case that has endured for years. And…
Read More