Patty Mechael’s Post

How do we balance learning from patient harm events with professional accountability and financial responsibility? When patient harm events occur are we consistently analyzing what happened, how it happened, and why it happened in an attempt to prevent similar events in the future? Are we sharing findings in an actionable way? What can we do today to improve the quality of healthcare delivery? Just some of the many questions I have after watching the documentary Bleed Out by Stephen Burrows yesterday. I don't have all the answers but I certainly have some ideas. Looking forward to the panel discussion about the documentary later today!! Link to Register - https://lnkd.in/ga3RPaar #HealthcareQuality #PatientSafety #PatientHarm #CPPS #CPHQ #NAHQ

join me at #ISCR2024 - Data management track to discuss how #Digitalhealthtechnology and #decentralizedclinicaltrials are impacting patient outcomes

The latest Friday Five features recommendations from the EPPh Consultation Review Ad-Hoc Committee. Key updates include the continuation of existing QA requirements, new PD/CEU obligations, and a push for equitable eChart access. Learn more about how we're advancing EPPh practice and improving patient care. Read the full update here: https://lnkd.in/gfjEiDRH #RegulatoryInsights #PharmacyStandardsMB #CPhMRegUpdates

Julia Hesse, Christine Savage and Sara Rau have published the article, "FTC Settlements Widen Efforts to Shield Health Data,” in the September 11, 2023 edition of Law360, related to gathering and sharing data collected through adtech tools. #FTC #adtech #healthcare #datasecurity

MAIA reporting automates and simplifies mandatory #lifesciencesreporting functions - including CSR, DSUR, TLF, and more – using a powerful combination of #genAI and human-in-the-loop presence. It’s past time to reclaim lost time and focus on what matters most: serving patients. For More Info On MAIA > Visit https://lnkd.in/eAXbX6hG #lifesciencesAI #lifesciencescompliance #healthcarecompliance

Excited to have our article on FTC AdTech enforcement trends published in Law360!

September is National #FallsPreventionAwarenessMonth, a nationwide effort to raise awareness on preventing and reducing #FallRisk. We prioritize continuous innovation and are committed to supporting our #LTC clients and their patients in a meaningful way. Improve resident safety at your #SNF with Data IQ’s soon-to-be-released Clinical Reporting! This powerful tool aids in #FallsPrevention by allowing users to analyze trends, identify at-risk patients, and reduce risks before they can occur. Stay tuned! #DataIQBI

🔍 UPDATED the Q&A on Regulation (EU) 2023/607 🔍 REV. 2 - July 2024 💡 To align the text with the Q&A on the extension of the IVDR transitional periods (https://lnkd.in/deyX6U76), EU Health has updated the Q&A document on practical aspects related to the implementation of Regulation (EU) 2023/607 on the extension of the MDR transitional period and removal of the sell-off periods. Download the revised document >> https://lnkd.in/dr_7cumM #MedicalDevice #MDR #EUregulation #IVDR #EUHealth

FDA's diagnostics office is keeping busy. Not only did it recently finish work (and send to OMB) its closely watch lab-developed test (LDT) rule, but this week it also sent for final OMB review 2 draft guidance documents that return to issues that challenged the office to historic proportions during the COVID-19 pandemic: what type of enforcement flexibility is appropriate for tests (IVDs and LDTs) in the face of a public health emergencies. One of the drafts will address "immediate public health response" in the Absence of an HHS Emergency Use Authorization declaration, and the other will address enforcement flexibilities once FDA has been granted EUA authorities for a particular threat. Both will likely be out within the month (though always hard to predict timing). #fda #diagnostics #covid19