Tyler Capeletti’s Post

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In one of the posts (https://t.ly/7q5x_), we examined how the FDA has included software (often referred to as 𝐂𝐃𝐒 𝐬𝐨𝐟𝐭𝐰𝐚𝐫𝐞) that is meant to 𝒔𝒖𝒑𝒑𝒐𝒓𝒕 𝒅𝒆𝒄𝒊𝒔𝒊𝒐𝒏-𝒎𝒂𝒌𝒊𝒏𝒈 𝒇𝒐𝒓 𝒉𝒆𝒂𝒍𝒕𝒉𝒄𝒂𝒓𝒆 𝒑𝒓𝒐𝒗𝒊𝒅𝒆𝒓𝒔, 𝒑𝒂𝒕𝒊𝒆𝒏𝒕𝒔, 𝒐𝒓 𝒄𝒂𝒓𝒆𝒈𝒊𝒗𝒆𝒓𝒔 𝒇𝒐𝒓 𝒕𝒉𝒆 𝒅𝒊𝒂𝒈𝒏𝒐𝒔𝒊𝒔, 𝒕𝒓𝒆𝒂𝒕𝒎𝒆𝒏𝒕, 𝒑𝒓𝒆𝒗𝒆𝒏𝒕𝒊𝒐𝒏, 𝒄𝒖𝒓𝒆, 𝒐𝒓 𝒎𝒊𝒕𝒊𝒈𝒂𝒕𝒊𝒐𝒏 𝒐𝒇 𝒅𝒊𝒔𝒆𝒂𝒔𝒆𝒔 𝒐𝒓 𝒐𝒕𝒉𝒆𝒓 𝒄𝒐𝒏𝒅𝒊𝒕𝒊𝒐𝒏𝒔 in section 201(h) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as well as how Section 3060(a) of the Cures Act amended the Food, Drug, and Cosmetic Act and under the section 520(o), certain software functions were excluded from the definition of the medical device. Prior to discussing the types of "𝐜𝐥𝐢𝐧𝐢𝐜𝐚𝐥 𝐝𝐞𝐜𝐢𝐬𝐢𝐨𝐧 𝐬𝐮𝐩𝐩𝐨𝐫𝐭" (𝐂𝐃𝐒) software functions that are not regarded as being a part of the definition of the device under section 520(o)(1)(E).  Let’s comprehend who is referred to as a 𝐇𝐞𝐚𝐥𝐭𝐡𝐜𝐚𝐫𝐞 𝐏𝐫𝐨𝐟𝐞𝐬𝐬𝐢𝐨𝐧𝐚𝐥 (𝐇𝐂𝐏). The term "HCP" as used by the FDA refers to a person who is authorized to administer health care and who has been granted a license, registration, or certification by a State or other regulatory body. This includes, but is not limited to, 𝑛𝑢𝑟𝑠𝑒 𝑝𝑟𝑎𝑐𝑡𝑖𝑡𝑖𝑜𝑛𝑒𝑟𝑠, 𝑟𝑒𝑔𝑖𝑠𝑡𝑒𝑟𝑒𝑑 𝑛𝑢𝑟𝑠𝑒𝑠, 𝑙𝑖𝑐𝑒𝑛𝑠𝑒𝑑 𝑝𝑟𝑎𝑐𝑡𝑖𝑐𝑎𝑙 𝑛𝑢𝑟𝑠𝑒𝑠, 𝑐𝑙𝑖𝑛𝑖𝑐𝑎𝑙 𝑠𝑜𝑐𝑖𝑎𝑙 𝑤𝑜𝑟𝑘𝑒𝑟𝑠, 𝑑𝑒𝑛𝑡𝑖𝑠𝑡𝑠, 𝑜𝑐𝑐𝑢𝑝𝑎𝑡𝑖𝑜𝑛𝑎𝑙 𝑡ℎ𝑒𝑟𝑎𝑝𝑖𝑠𝑡𝑠, 𝑝ℎ𝑎𝑟𝑚𝑎𝑐𝑖𝑠𝑡𝑠, 𝑝ℎ𝑦𝑠𝑖𝑐𝑎𝑙 𝑡ℎ𝑒𝑟𝑎𝑝𝑖𝑠𝑡𝑠, 𝑝ℎ𝑦𝑠𝑖𝑐𝑖𝑎𝑛𝑠, 𝑝ℎ𝑦𝑠𝑖𝑐𝑖𝑎𝑛 𝑎𝑠𝑠𝑖𝑠𝑡𝑎𝑛𝑡𝑠, 𝑝𝑠𝑦𝑐ℎ𝑜𝑙𝑜𝑔𝑖𝑠𝑡𝑠, 𝑟𝑒𝑠𝑝𝑖𝑟𝑎𝑡𝑜𝑟𝑦 𝑡ℎ𝑒𝑟𝑎𝑝𝑖𝑠𝑡𝑠, 𝑎𝑛𝑑 𝑠𝑝𝑒𝑒𝑐ℎ-𝑙𝑎𝑛𝑔𝑢𝑎𝑔𝑒 𝑝𝑎𝑡ℎ𝑜𝑙𝑜𝑔𝑖𝑠𝑡𝑠, 𝑡𝑒𝑐ℎ𝑛𝑜𝑙𝑜𝑔𝑖𝑠𝑡. #FDA #HCP #HealthcareProfessional #software #CDS #medicaldevice #clinical #decision

Unlocking the Potential of Med Tech: The Role of an RN Clinical Specialist I've been asked by friends, family, and former colleagues; what do I do as an RN clinical specialist? The next question is always... do I miss bedside nursing? In today's rapidly evolving medical landscape, the role of an RN Clinical Specialist has never been more crucial. We bridge the gap between innovative medical devices and their real-world application, ensuring healthcare professionals are well-trained and confident in using the latest technologies to improve patient care. To this end, I spend most workdays in hospitals working with the same healthcare professionals I always have, helping to provide the best patient care possible... I guess the only thing I miss... my mad IV skills. I'm a little out of practice. 😎 #HealthcareInnovation #MedicalTechnology #ClinicalSpecialist #PatientCare #MedTech

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Happy Medical Coders Day! 🎉 Today, we celebrate the unsung heroes of healthcare - our dedicated medical coders. Their meticulous work ensures the accuracy and integrity of medical records, which is crucial for patient care and the smooth operation of our healthcare system. Medical coders are the backbone of healthcare, translating complex procedures into codes that enable seamless communication and billing. They navigate the ever-evolving landscape of healthcare regulations with precision and resilience. Let’s take a moment to appreciate the hard work and dedication of medical coders around the world. Your contributions do not go unnoticed, and we thank you for keeping our healthcare system running efficiently. Here’s to all the medical coders out there - thank you for all that you do! 🙏 #MedicalCodersDay #HealthcareHeroes #MedicalCoding Feel free to personalize this message with your own experiences or shoutouts to medical coders you know. Posting this on LinkedIn will help spread awareness and appreciation for the vital role that medical coders play in our healthcare system. 🌟

While not mandated by the state, most healthcare employers prefer certification if you want to become a medical assistant (MA) in California. When MAs are certified, employers know they have the knowledge and skills to provide the best patient support. By exploring how to become a medical assistant in California, you can take the first step toward a brighter future. https://lnkd.in/gSZzEBnJ #BayAreaMedicalAcademy #MedicalAssistant #MedicalAssistingTrainingSchool #CareerTraining #HealthcareTraining #Blog

A study examined medical assistant staffing ratios in primary care practices, revealing that health-system practices were often understaffed. Many practices are expanding the roles of medical assistants, a rapidly growing occupation in the US primary care workforce. What's your talent strategy for medical assistant staffing? https://buff.ly/3RcLuFI #medicalassistants #healthcarestaffing