Meeting reporting obligations for medical devices

Medical Devices Regulation 2017/745 and In Vitro Diagnostic Medical Devices Regulation 2017/746 U.S. manufacturers of medical devices who are placing their devices on the European market have been facing many challenges relating to the new coming European legislation. The deadline for implementing the European Medical Devices Regulation (EU MDR 2017/745) and In Vitro Diagnostic Medical Devices Regulation (EU IVDR 2017/746) was postponed from May 2020 to May 2021 due to the COVID-19 outbreak, giving manufacturers more time to prepare. Manufacturers

Read More »

Supervised learning approach a necessary and important step in monitoring drug-related social media posts

Social media, such as Facebook and Twitter, provides many users with an outlet to share opinions online among a broad audience.  Some of these discussions concern their experiences with prescription and over-the-counter (OTC) medications.  These conversations can have an outsized influence on the public perception of the products they discuss.  The sentiment of individual posts regarding the efficacy and side effects of medications can be either positive or negative.  Consumers may also disclose misuse or abuse of the product.  Occasionally,

Read More »

COVID-19 Survey is now available in Spanish and Italian

To increase the reach, Veracuity LLC and Alliance for Clinical Research Excellence and Safety (ACRES) now offer the survey in multiple languages, including Italian and Spanish. TransPerfect Life Sciences, a leading provider for global development and commercialization of drugs, treatments, and devices, has generously donated translation services in support of these efforts. Healthcare providers or hospitals interested in completing the survey or contributing data to the initiative can do so at https://www.acresglobal.net/covid-19. The target audience for the survey is any

Read More »

Veracuity joins COVID-19 Evidence Accelerator

In April 2020, the Veracuity team developed a survey tool for the collection of data from hospitalized COVID19 patients. This initiative was implemented and widely distributed by the Alliance for Clinical Research Excellence and Safety (ACRES). At the recommendation of the Principal Deputy Commissioner of Food and Drugs, Amy P. Abernethy, M.D., Ph.D., Veracuity joined the COVID-19 Evidence Accelerator, organized by the Reagan-Udall Foundation for the FDA in collaboration with Friends of Cancer Research. The scarcity of evidence and ambiguity

Read More »

ACRES and Veracuity Launch COVID-19 Real World Evidence Initiative

The Alliance for Clinical Research Excellence and Safety (ACRES), a Massachusetts-based global non-profit collaborative, is distributing a simple online tool for collection and analysis of real-world data on predisposing conditions, treatment strategies, outcomes and side effects experienced by COVID-19 patients. This survey tool, designed by Veracuity LLC, expands data collection from providers and hospitals in near-real-time to enhance understanding of the COVID-19 pandemic, including risk-factor identification, triage, treatment management and outcome predictors to gain insight into the safety and efficacy

Read More »

Benchmarking AI in healthcare

Artificial intelligence (AI) models are becoming an indispensable part of healthcare delivery due to the ever-growing volumes of data the sector produces. The technology supports countless operations, from pattern recognition and classification of disease entities to clinical decision-making. The purpose of AI is to decrease the burden of repetitive tasks on staff and provide information support. Exploration of the applications of AI in health has attracted considerable investment. Despite the significant potential, there are numerous unresolved issues in AI applications

Read More »

The opioid epidemic in drug safety reporting systems

Last week, the founder of Insys Therapeutics, John Kapoor (76), was sentenced to 66 months in prison for orchestrating a scheme to bribe physicians to prescribe Subsys, a highly addictive form of fentanyl, to patients who did not need this drug. Five corporate executives, including Kapoor, were convicted of racketeering conspiracy. Under his leadership, John Kapoor exercised tight control over all decisions within Insys. At dinner parties, disguised as peer-to-peer educational lunches, prescribers received bribes and kickbacks for Subsys prescriptions

Read More »

The impact of data breaches in healthcare on research

In the U.S., summary details of private health information breaches that involved more than 500 individuals are available at the HHS OCR portal called Wall of Shame for the public to view [1]. In Europe, EU-level legislation on data privacy has to be transposed into national law. National regulators are also responsible for implementation and enforcement. Unlike in the U.S., information on data breaches and the nature of the incidents is not available in Europe. There is no one place

Read More »

Subscribe to our newsletter