Technical due diligence is the process to better evaluate software and identify its strengths and weaknesses. TDD is a critical step in any software-centric transaction.
Read MoreA standard approach for representing patient addresses across all health IT systems was needed to improve patient matching using accurate address information. Enter Project US@, the “Unified Specification for Address in Health Care.”
Read MoreAs 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…
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…
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…
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…
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-…
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.…
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…
Read More