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Overview: If you've ever felt the frustration of unpredictable results in splint therapy, you're not alone. Join us for this eye-opening course as Dr. Jesek zeroes in on the dentist's role in diagnosis and treatment of TMJ conditions as they relate to occlusion. Why should you Attend: Dr. Jesek is the founder of Jesek Seminars for Success: Promoting and Teaching Excellence in Dentistry (an approved AGD Pace provider.). He has presented at national meetings for the Academy of General Dentistry, the American Equilibration Society, the American Dental Association, the American Academy of Pain Management and Chicago Dental Society Midwinter Meeting. Seminar attendees appreciate his passionate, easy to understand approach and his teaching style, which enables deep learning and provides tools they can use when they get back to the office Monday morning. Areas Covered in the Session: TMJ anatomy and muscles of mastication function. How to use bimanual guidance to determine TM joint health. How to palpate muscles of mastication. Differential diagnosis of TMD and occlusomuscle disorders. Temporomandibular joint rehabilitation. How to know when occlusal treatment will work predictably. How to identify and treat trigger points and muscle pain. How occlusal appliances make restorative dentistry easier. What imaging is needed: panorex, transcranial, tomogram, CT or MRI, and why. How to use emergency appliances to eliminate acute occlusomuscle pain. When you can just equilibrate the teeth and not use an occlusal appliance. How to stop the need of grinding on your crowns at delivery. Who Will Benefit: Dentist and Hygienists Speaker Profile Dr. Warren Jesek graduated from Millikin University with a B.A. in biology and chemistry. After, he completed graduate work studies in anatomy at the University of Nebraska before attending Loyola University Dental School where he received his dental degree in 1979. He has maintained a private general practice in Decatur, Illinois since 1

Overview: Do you know the steps that going into making new clients aware of your practice? From the first time they become aware of you brand, every step you take and every interaction along the way is more important than you know! Learn how to keep your customers coming back for more and singing your praises to those that matter, as well as a surefire formula to make sure your marketing dollars are working as well as you think they are! (Hint: We'll be GIVING YOU the formula to use from here on out!) Areas Covered in the Session: Each step of the customer acquisition, retention and upsell process Formula to determine the ROI of marketing expenses Who Will Benefit: Medical Practice Owners Managers Marketing Associates Speaker Profile Mara L. Shorr BA, MBM-C, CAC I-VIII is the founder and managing partner of The Best Medical Business Solutions, a Florida-based medical practice consulting firm assisting practices with their operational, administrative and financial health. Jay served as the Vice President of Operations and Practice Administrator for a leading Board Certified Dermatologist and Cosmetic Surgeon in South Florida until her passing in June 2012, and is currently a partner in a leading South Florida plastic surgery center and medspa. A Temple University graduate, Jay has served as a professional motivational speaker for nearly a dozen industry organizations, including the American Academy of Cosmetic Surgery, THE Aesthetic Show, The Aesthetic Academy, The Medical Entrepreneur Symposium, the American Academy of Facial and Reconstructive Plastic Surgery, the American Academy of Anti-Aging Medicine, the American Academy of Cosmetic Surgery, Vegas Cosmetic Surgery and Global Aesthetics, and more! In addition, he is a Certified Medical Business Manager from Florida Atlantic University. He is a Certified Medical Business Manager (CMBM) from Florida Atlantic University and a Certified Aesthetic Consultant (Levels I-VII) from The Aesthetic Practice Associa

Overview: The idea of providing health care treatments and insurance coverage according to "medical necessity" determinations seems eminently reasonable. Its obvious ethical thrust is to discourage unnecessary, wasteful or fraudulent practices. As practically implemented, however, "medical necessity" regulations and determinations have proven remarkably controversial and elusive. First of all, the language connected with medical necessity is inherently vague. Language to the effect that a treatment is medically necessary if it is "likely to achieve a significant practical improvement," is "realistic," or "reasonable" will predictably cause disputes between payors and providers of care. Second, the persistence of these disputes calls into question whether evidence based practices have evolved to a point where they are all that reliable and useful. Third, medical necessity determinations incur problems as to who should ultimately make them: payors, health providers or the courts. Obviously, whoever controls the definition of medical necessity controls the flow of health care dollars. While ethical theory can offer important insights about our moral obligations, it remains unable to reliably translate its theoretical principles and rules bearing on harms, benefits and justice into informing medical necessity determinations. Thus, resolving disputes over medical necessity have taken a procedural approach that looks to the interpretation of contractual language in insurance policies, often at the bench of an administrative law judge. This presentation will advance a reasonable set of strategies whereby a convincing case can be made for certain care interventions qualifying as "reasonable and necessary." Why should you Attend: Despite their central importance as a locus for determining reimbursement, "medical necessity" regulations and determinations have proven remarkably controversial and vexing for at least the last 20 years. Yet, whoever controls the definition

Overview: Joint Commission standards set a high bar for hospital medical staff bylaws. Since the 2011 changes to MS 01.01.01, bylaws must meet 37 elements of performance including hearing provisions, credentialing requirements, department director duties and more. But don't stop there-additional requirements are scattered through other Joint Commission standards. Each standard, element of performance and their quirks will be addressed and means of compliance explored. Why should you Attend: Joint Commission accreditation, sought by the overwhelming majority of American hospitals, hinges upon compliance with the Standards and their Elements of Performance set forth in the Joint Commission Accreditation Manual for Hospitals. Some of the most complex, detailed standards involve medical staff bylaws provisions and processes. Federal legal requirements change frequently in ways that unexpectedly affect these Joint Commission standards. This webinar addresses the most up -to-date Joint Commission requirements and industry best practices for medical staff bylaws compliance. Areas Covered in the Session: Joint Commission Standards for Hospitals Medical Staff Bylaws Hospital accreditation requirements Who Will Benefit: Medical Staff President Bylaws Committee Chair Chief Medical Officer Vice President of Medical Affairs Chief of Staff Director of Medical Staff Medical Staff Attorney Hospital Counsel Medical Staff Manager Speaker Profile Elizabeth A. Snelson represents medical staffs across the country, focusing on medical staff bylaws, and works for medical societies on medical staff issues. A frequent speaker on medical staff legal issues, Ms Snelson presents at medical staff leadership retreats, and in programs sponsored by state medical staff services associations and medical societies, the American Medical Association, the American Bar Association, and other organizations. She is Past President of the American Society of Medical Association Counsel, Vice Presi

Overview:   We will review the various elements of the physician employment agreement, focusing on the pitfalls and the problems that can develop when the agreement does not clearly define the relationship, and/or when the parties do not fully understand what is being agreed to. Such items as term and termination, termination for cause, duties of the physician, call, non-compete, and compensation are all items that should be clearly set out in the agreement and fully understood by the parties. Why should you attend: Formal written contracts establish the legal relationship between the parties; they state the terms and conditions of that relationship and the rights and obligations of each party. They confirm the intentions and relationships of the parties as they enter into this relationship, and they eliminate uncertainties regarding mutual rights, obligations, and relationships. If everything remained as it is at the time the agreement is signed, there would be little need for formal documents. However, the agreement serves to protect against future disputes. Therefore, it should include as precise language as possible. Ambiguous terms in agreements are of little effect when disputes occur over the meaning of a party's rights or obligations. You should attend to gain an understanding of what should and what should not be in a physician employment agreement. Areas Covered in the Session: Corporate practice of medicine Term and termination Termination for Cause Severance pay Provision allowing physician to terminate for cause Severance pay Duties of the physician Standards for the provision of professional services Referral to hospital Continuing medical education Who Will Benefit: Physicians Healthcare executives Physician practice managers Speaker Profile William Mack Copeland MS, JD, PhD, LFACHE, practices health care law in Cincinnati at the firm of Copeland Law, LLC. He is also president of Executive & Managerial Development Group, a consu

Overview:  Emotionally difficult or painful conversations are very common in health care. Consequently, it is quite remarkable that health care training programs do not spend more time teaching future health professionals the kinds of emotional and relational skills that are often required in these kinds of patient-provider interactions. This presentation will discuss the architecture of the painful conversation by examining : Its effect on the professional's sense of self and especially his or her need to preserve self-esteem The critical role of feelings and emotions, and The nature and value of empathy. The latter half of the presentation will consist of various strategic and practical recommendations so that emotionally challenging conversations might be conducted artfully, especially with "difficult" or "impossible" patients. Areas Covered in the Session: By the end of this presentation, learners will be able to: Relate the painful conversation to their construction of their professional "self"; Explain how an ability to control one's feelings can influence the success or failure of an emotionally difficult conversation; List a number of empathic responses that are useful in conducting difficult conversations Who Will Benefit: Any health professional who has to communicate with others. Speaker Profile John D. Banja is a Professor in the Department of Rehabilitation Medicine and a medical ethicist at the Center for Ethics at Emory University. He also directs the Section on Ethics for the Atlanta Clinical and Translational Science Institute at Emory. Dr. Banja received a doctorate degree in philosophy from Fordham University in New York and has taught and lectured on topics in medical ethics throughout the United States. He has authored or coauthored over 200 publications and has delivered over 800 invited presentations at regional, national, and international conferences. He currently serves as the Editor of the American Journal

Overview: This presentation will introduce the participants to changing role of the panoramic x-ray machine in dental offices today. Its expanding role in extra oral exposures and enhanced diagnostic capabilities is forever changing the path of dental x-ray imaging. Digital radiography is rapidly improving in diagnostic quality and loweringthe radiation exposure with ultra-low dose technology. We can have extra oral 2D bite wings and periapical x-rays with less radiation and greater diagnostic capability than traditional intraoral x-rays. The time has come that all dentists should have access to 3D-Cone Beam Computer Tomography. It is rapidly becoming the standard of care. Why should you Attend: Digital radiography is rapidly changing in today's dental offices. The new technology is revolutionizing patient flow and improving diagnosis. Dr. Jesek is at the forefront of this technology, using both 2D and 3D radiography. Seminar attendees will get easy to understand approach, which enables deep learning and provides tools they can use when they get back to the office Monday morning. Areas Covered in the Session: CBCT can be used to in areas of general dentistry to improve patient acceptance and quality of treatment outcomes. General and Restorative Dentistry Oral Surgery Implant Dentistry Endodontics Periodontics Orthodontics Sleep Apnea/Air way Who Will Benefit: Dentists Hygienists Assistants Speaker Profile : Dr. Warren Jesek graduated from Millikin University with a B.A. in biology and chemistry. After, he completed graduate work studies in anatomy at the University of Nebraska before attending Loyola University Dental School where he received his dental degree in 1979. He has maintained a private general practice in Decatur, Illinois since 1979. Unique to the area, his practice houses a crown and bridge laboratory with three technicians focusing on CAD/CAM milling technology to produce metal-free inlays, crowns and bridges. Dr. Jesek continued his training

Course "HIPAA Security & Privacy Official - Roles and Responsibilities" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Being the HIPAA Security and Privacy Official involves not only ensuring you know the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your HIPAA Security and Privacy Official needs to understand what all the HIPAA requirements are or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive seminar. Why you should attend: The HIPAA Security and Privacy Official is the backbone of any organization's compliance program. Often times this role is assigned as collateral duty in smaller organizations. Regardless the size of an organization, the HIPAA Security and Privacy Official must know all the requirements for compliance. This is a critical element of the position. Attendees will leave the course clearly understanding the role and all the requirements as the designated as a HIPAA Security and Privacy Official. This seminar will cover reviews, creation, and amending policy and procedure. After completing this course, a HIPAA Security and Privacy Official will have a clear understanding for what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session: Why was HIPAA created? The Role and Responsibilities of the HIPAA Security and Privacy Official Complying with HIPAA Requirements? What are the HIPAA Security

Course "HIPAA - Putting an Organizational Compliance Program in Place" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive 2 day training course. Why you should attend With an increase in HIPAA enforcement and Phase 2 audits underway, many organizations need to fully understand the requirements of a compliance program. Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and what steps need to be taken to mitigate risk. The seminar will include practical exercise to assist in knowing how to develop, review, and amend HIPAA policy and procedure. After completing this course, a Covered Entity or Business Associate will have a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session * Why was HIPAA created? * What is HITECH and the Omnibus Rule? * Who Must Comply with HIPAA Requirements? * What are the HIPAA Security and Privacy Rules? * What is a HIPAA Compliance Program? * What is a HIPAA Risk Management Plan? * What is meant by

Construction Safety Orientation Construction Safety Orientation is part of Occupational Safety and Health Administration (OSHA)'s safety initiatives for those employed in the construction industry. Construction Safety Orientation is offered to employers and employees in the construction industry by OSHA or its authorized trainers. Construction Safety Orientation is offered as either a 10-hour or 30-hour course to employees by OSHA-authorized trainers. The aim of the Construction Safety Orientation training is provide training to employees and employers in this industry to help them recognize, abate, avoid, and prevent injuries in the workplace. In addition, Construction Safety Orientation also involves providing training to the employees and employers about their rights and duties at the workplace. s Outreach Training Program is voluntary There are two reasons for OSHA recommends Construction Safety Orientation: OSHA's Outreach Training Program is voluntary; OSHA's Outreach Training Program, being basic, does not provide the full training requirements that the employer has to meet under set OSHA standards. Because of this reason, OSHA's Outreach Training Program is not considered a certification. The need for Construction Safety Orientation The sheer size of the American construction industry is the best reason for the need for Construction Safety Orientation: A little over two percent of the entire American population - something like 6.5 million people are engaged in the construction industry at more than a quarter of a million construction sites across the nation. This perhaps gives some perspective of the magnitude of the tendency for injuries and deaths in this industry. In fact, it is known that construction accounts for the highest rate of fatal injuries among all industries in the US. In a construction workplace, workers could be prone to almost any kind of injury or hazard. According to osha.gov, the most common reasons include: Falls (from heights);

Course "HIPAA - Putting an Organizational Compliance Program in Place" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive 2 day training course. Why you should attend: With an increase in HIPAA enforcement and Phase 2 audits underway, many organizations need to fully understand the requirements of a compliance program. Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and what steps need to be taken to mitigate risk. The seminar will include practical exercise to assist in knowing how to develop, review, and amend HIPAA policy and procedure. After completing this course, a Covered Entity or Business Associate will have a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session: · Why was HIPAA created? · What is HITECH and the Omnibus Rule? · Who Must Comply with HIPAA Requirements? · What are the HIPAA Security and Privacy Rules? · What i

Micro guide catheters are used in order to guide the urethra so that you can have an easy time inserting your pet's urethra and not be worried about any kind of blockage at all. There are many types of these devices available in the market. Some of these are manual tube and electric as well. Many people prefer to use micro guide catheters because they are made very simple and with great ease of use. A growing number of surgical procedures for treating cardiovascular diseases is fueling the growth of the micro guide catheters market. According to the American College of Cardiology Foundation, in 2017, emergency medical services-assessed out-of-hospital cardiac arrest occurred in an estimated 356,461 Americans; emergency medical services treatment was initiated in 52%. In the United States in 2019, coronary events are expected to occur in about 1,055,000 individuals, including 720,000 new and 335,000 recurrent coronary events. The increasing development of modern disposable catheters that are safer and more comfortable to insert is further projected to foster the growth of the micro guide catheters market. North America is projected to gain significant growth over the forecast period and this is attributed to the continuous launch of innovative products by ley players in the region. For instance, in March 2017, Teleflex Inc. has announced 510(k) clearance by the U.S. Food and Drug Administration (FDA) and the U.S. commercial launch of the TrapLiner Catheter. The TrapLiner Catheter was developed by Vascular Solutions Inc., which was acquired by Teleflex. Read more @ https://coherentmarketinsights-blog.blogspot.com/2021/02/rise-in-number-of-cardiovascular.html

Thyroid disorder therapy is a fast-growing area of treatment for people suffering from this condition. The thyroid gland is responsible for regulating metabolism and temperature, with control through the use of the thyroid gland located in the neck just below the voice box. A person suffering from Thyroid disorder have signs and symptoms such as weight gain, fatigue, depression, and constipation. Thyroid Dysfunction may be caused by many factors, and the causes and symptoms are different in every person. Thyroid disease is a highly treatable condition if diagnosed early enough, although treatment options will vary from person to person depending on their age, overall health, and underlying health problems. The growing prevalence of thyroid disorder around the globe is a prime factor driving the growth of thyroid disorder therapy market. According to the American Thyroid Association (ATA), an estimated 20 million Americans have some form of thyroid disease. Up to 60 percent of those with thyroid disease are unaware of their condition. Women are five to eight times more likely than men to have thyroid problems. Read more @ https://coherentmarketinsights-blog.blogspot.com/2020/12/increasing-fda-approval-for-thyroid.html

Are you struggling with the fact that you really don't know anything about how to get into shape? If you're busy living in yesterday's errors, many of your decisions will be founded on guilt and shame instead of what you really want (and need) to accomplish to achieve your goals. Real change comes from day-to-day choices and becoming mindful and basing your choices on what you need now (rather than what you did or didn't do yesterday) will make your exercise life much more passable. What if I can offer you a solution that will help you to attain greatness, to become a success and learn about the best ways to get in shape? In this book, you will learn about: - Navigate the Astral Plane - MIRROR MADNESS - The Health Zen - Vitamin Vitality - Native American Healing - Boost your Health with Gua Sha - Beautiful Body Essential - Secret of Food Combination - Lose Weight Fasting - Child Diet - many other useful things!

Are you struggling with the fact that you really don't know anything about how to get into shape? If you're busy living in yesterday's errors, many of your decisions will be founded on guilt and shame instead of what you really want (and need) to accomplish to achieve your goals. Real change comes from day-to-day choices and becoming mindful and basing your choices on what you need now (rather than what you did or didn't do yesterday) will make your exercise life much more passable. What if I can offer you a solution that will help you to attain greatness, to become a success and learn about the best ways to get in shape? In this book, you will learn about: - Navigate the Astral Plane - MIRROR MADNESS - The Health Zen - Vitamin Vitality - Native American Healing - Boost your Health with Gua Sha - Beautiful Body Essential - Secret of Food Combination - Lose Weight Fasting - Child Diet - many other useful things!

Social media and healthcare: The advent of the social media into the healthcare industry has thrown open a hitherto unknown dynamic. It presents the industry the kind of opportunities that were hard to come by till now. Yet, it is full of challenges. It is now an inescapable fact and a given: the onslaught of the social media into the healthcare industry cannot be reversed. The wave is too strong to resist. The explosion in the use of social media has impacted the healthcare industry on a scale that is unprecedented. The universal pervasiveness of the social media Social media and healthcare have become great buddies mainly because of the sheer power of reach of the social media. What started out essentially as services that shared photos and messages has turned out to be a giant opportunity for the healthcare industry. Today, it is something that no one in the healthcare industry -or those outside it, such as the lay young population that seeks medical information - is insulated from. Now, not only patients, but also physicians and everyone of any significance in the healthcare industry use the social media to disseminate information. Social media and healthcare have become strongly paired also because they help in keeping the patient in close contact with the healthcare provider. It is no surprise that the social media have broken the barriers of age and geography in reaching out to the highest and widest range of users. Some trends about social media and healthcare: It is estimated that a fifth of the entire American population exchanged medical information over the social media in 2010 About three-fourths of all patients use the social media for some information before reaching a healthcare provider At least a thousand top US hospitals use social media for communicating with patients and providers Globally, up to half a billion people could be linking social media and healthcare by using the former Now, the challenges: Despite social media in t

Patient Safety in Medical Education A very important aspect of medical education that had been overlooked for a long time is patient safety. When patient safety in medical education gets relegated to the backseat; the result is there for everyone to see: something like close to a 100,000 deaths at the turn of the previous century, according to the alarming results of a comprehensive study carried out by the Institute of Medicine. The tragedy of these deaths is that these were preventable. This reinforces the belief that patient safety in medical education is the core factor, which if handled properly, can save thousands of lives. How does patient safety in medical education come about? It goes without saying that physicians and other caregivers practice in their professions what they learn in schools. So, patient safety in medical education has to be incorporated into the curriculum at the earliest stages. Hospitals, medical colleges and other institutes that impart medical education have now started taking more than mere baby steps in inculcating patient safety in medical education as a core part of teaching, the already heavily burdened curriculum in medical education notwithstanding. Efforts by medical education bodies Following the publication of the IOM report, the American Association of Medical Colleges (AAMC) and the Curriculum Management and Information Tool (CurrMit) in the US and Medical Schools Council and the General Medical Council (GMC) in the UK sprang into action, announcing a slew of measures aimed at bringing about and reinforcing patient safety in medical education. Entire lessons and chapters are devoted to patient safety in medical education. Keywords and technical jargon relating to patient safety are now a highly visible aspect of patient safety in medical education. These are spread across all disciples and subjects of medical education, be it gynecology or anesthetics. What should curricula teach about patient safety in medical edu

Implementation of Regulatory Aspects of Clinical Research is critical One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other regulatory bodies have spelt out a number of regulations that have to be complied with if the clinical research is to be approved. These regulatory requirements cover all aspects of clinical research. A look at some of these regulatory aspects would be instructive: FDA requirements on regulatory aspects of clinical research The FDA has an exhaustive list of regulations relating to Good Clinical Practice (GCP), the area which forms the backbone of regulatory aspects of clinical research. The FDA has a series of regulations that are aimed at bringing in discipline and process into clinical research. It implements all the laws relating to GCP passed by the American Congress. At present, there are a huge number of regulatory standards and requirements that have to be complied with by those undertaking clinical research in the US. These regulations are codified in the 21 CFR series. Notable sections of the 21 CFR series relating to regulatory aspects of clinical research include: 21 CFR Part 11 21 CFR Part 16 21 CFR Part 50 21 CFR Parts 50 and 56 21 CFR Part 54 21 CFR Part 58 21 CFR Part 312 21 CFR 312.120 21 CFR Part 314 21 CFR Part 320 21 CFR Part 511 21 CFR Part 514 21 CFR Part 601 21 CFR Part 812 21 CFR Part 814 EU requirements on regulatory aspects of clinical research In the EU, the core aspect of regulatory aspects of clinical research relates to the primary importance given to the subjects in a clinical research. For example, regulatory aspects of clinical research France are guided by the Public Health Code and Civil Code. This Code contains a list of regulatory conditions clinicians are obliged to adhere to. These regulations are to be monitored by a number of regulation enforcement bodies that the French governm

HIPAA Breach Notification Rules and its new version : Let us begin at the beginning: What is breach notification? The term is pretty simple to understand. It means notifying the authorities whenever there is a breach of Protected Health Information (PHI). Covered Entities (CE's) and Business Associates (BA's), who are closely associated with PHI, and individuals whose PHI data are breached, are required to bring such data breaches to the notice of the authorities, whenever there is one. A breach notification is a mechanism that is aimed at ensuring that BA's and CE's meet requirements in the HITECH Act in the American Recovery and Reinvestment Act of 2009 (ARRA). To whom should the affected individuals and CE's and BA's complain? Whenever there is a breach of PHI by a CE or a BA, or if there is violation of the Privacy, Security, or Breach Notification Rules, the affected individual can complain to the Office for Civil Rights (OCR), which will initiate investigation into these complaints. Whenever a CE or a BA detects a breach, it can complain to the Secretary of Health and Human Services (HHS). In addition, the HIPAA breach notification rules have clear guidelines on how to report breaches in the following classifications: HIPAA's definition of a breach A breach of PHI is said to have taken place when any unpermitted use or disclosure that compromises the security of the data in the PHI takes place. Any such action, resulting in the breach of any kind of data contained in a PHI, big or small, is considered a breach, unless the CE or BA can explain that the data that got breached into was not serious enough, from its risk assessment point of view, to warrant immediate intervention. The new HIPAA breach notification rules The HHS embarked on a new HIPAA breach notification program, the HIPAA Privacy, Security, and Breach Notification Audit Program, with which it seeks to bring a few changes into the existing HIPAA breach notification rules. This new Audit Pr

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp