Unbiased Analysis of Today's Healthcare Issues
In recent years, FDA has approved a number of pieces of software that use artificial intelligence (AI) under its medical device approval system. FDA approved only 5 AI-power medical devices in 2015, but approved 115 of these in 2021 and likely will approve even more in 2022. Which companies are the ones with the most…
That is the topic of a new paper by Drummond et al. (2022). When medical devices receive regulatory approval, payers can make one of three coverage decisions: (1) approve, (2) reject or (3) coverage with evidence development (CED). Note that all countries approve medical devices based on safety and efficacy but only England, the Netherlands,…
Performance-based risk sharing (PBRS) have grown in importance in recent years. While most PBRS are used for expensive pharmaceutical products, PBRS also have been used with medical device and diagnostic manufacturers. Device/diagnostic PBRS may differ from those of pharmaceuticals for a number of reasons. First, while health insurers bear the burden of paying for most…
According to a recent study of patients with hypertension, the answer is yes. The study by Kronish et al. (2016) used a cluster randomized trial design made up of 24 providers and 100 patients. Half of the providers were randomized to receive received a report summarizing electronically measured patient adherence to their blood pressure regimen as well as and recommended clinical to…
The answer: more competition leads to more technology adoption. This is the finding from a study by Karaca-Mandic et al. (2016). They use data from 100% Medicare claim in 2003 and 2004 as well as linked information on hospitals [American Hospital Association (AHA) Annual Survey] and physicians [American Medical Association (AMA) Masterfile]. Competition is measured two…
Typically, the FDA evaluates drugs and devices based on whether they are safe and effective. Patient treatment preferences play little to no role in whether a drug or device is approved by the FDA. However, times are a changing. On Wednesday, the FDA released draft guidance whereby they recommend the inclusion of patient preference information…
Right now, the answer is no, but in the near future, this may no longer be the case. The FDA has released a draft guidance on how it will regulate the new generation of wearable technology. This guidance says it will not regulate “general wellness” products like the FitBit. However, if the wearable cites health benefits for…