Are Photos Like Fingerprints? BIPA and Biometric Privacy Laws
February 22, 2023
, ,
Illinois’ BIPA is a model for upcoming biometric legislation; we expect 20% of states will have biometric privacy laws by 2024.
Articles about Health IT
The DOJ’s Civil Cyber-Fraud Initiative
December 19, 2022
,
The most recent Health IT vendor to settle with the government is a direct result of the DOJ’s new Civil Cyber-Fraud Initiative.
FDA Releases Final Guidance on Clinical Decision Support Software as a Medical Device
December 8, 2022
,
Quandary Peak’s review of FDA’s final guidance leads us to believe we could see meaningful expansion of the amount of CDSS qualifying as a medical device, which could subject many current and future CDS software applications to FDA oversight.
How Project US@ Fits into the U.S.’s Developing Health IT Infrastructure
May 20, 2022
Quandary Peak Research
A 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.”
Understanding Medical Device Cybersecurity & the FDA’s Role
April 25, 2022
As medical devices evolve to better treat and monitor patient health, cybersecurity remains a top priority. As per FDA guidance, “medical device security is a shared responsibility…”
Clinical Decision Support (CDS) Software to Become an FDA Priority in 2022
December 16, 2021
Quandary Peak Research
The 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.
FDA Updates Medical Device Software Guidance for First Time in 16 Years
December 6, 2021
Quandary Peak Research
The FDA has announced updated software guidance for Software in a Medical Device (SiMD) or Software as a Medical Device (SaMD).
Understanding Electronic Health Information Under the 21st Century Cures Act
November 18, 2021
Quandary Peak Research
The digitization of medical records should lead to streamlined access for patients, efficiency upgrades for providers, and economic opportunity for developers. These benefits exist in theory, but not in practice—due to cybersecurity concerns and the associated costs.
Healthcare Data-Sharing System May Create Privacy Risks
April 24, 2020
Quandary Peak Research
In a piecemeal regulatory environment, consumers will bear the brunt of the responsibility for vetting any app they choose to give access to their medical information. How that information is protected will be the province of third parties – until legislated otherwise.
What Does DNA Use for Facial Mapping Mean?
January 8, 2020
Quandary Peak Research
DNA phenotyping has the potential for positive use cases for law enforcement, but it is still early days for the technology. As it evolves, it appears more information and review are necessary to come to a true conclusion about its efficacy – and to develop the guidelines and processes to safely use it.
