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Roger Steven

OIG CIAs: What Do They Mean To Your Compliance Program? - 0 views

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    Overview: Learn how to improve your healthcare compliance program by using requirements found in corporate integrity agreements (CIAs) issued by the OIG. By proactively incorporating various features of CIAs, healthcare providers of all types can be better assured of meeting compliance standards. While there are many different types of healthcare compliance issues, probably the area of most concern is that of properly filing claims and receiving appropriate reimbursement. The OIG has issued various types of guidance including Federal Register entries, fraud alerts, and issues as listed in the OIG Work Plans. By providing such guidance, the OIG has given healthcare providers notice so that there can be no defense of not knowing about an issue. By organizing your compliance program to detect and then correcting various types of issues is a major objective of having a compliance program. Understanding systematic processes for improving your healthcare compliance program using CIA requirements can forestall possible criminal and civil monetary penalties. The hundreds of CIAs that have been developed when the OIG detects fraudulent activities can be used as a guide for developing and improving healthcare compliance programs for all types of healthcare providers. The process of statistical extrapolation is used by the OIG when conducting studies in order to determine recoupment amounts. Statistical extrapolation can also be used by healthcare providers when determining possible overpayments. However, the proper use of statistical extrapolation is a formal and complex mathematical process that must be properly applied. The OIG CIAs provide another resource for healthcare providers to study, understand, and then apply as appropriate. Why should you Attend: What are the OIG Corporate Integrity Agreements (CIAs)? Why does the OIG issue CIAs? Can I use general requirements from CIA to avoid monetary penalties or even avoid going to jail? Can any healthcare provider use
Roger Steven

Seminar on Texting and E-mail with Patients: Patient Requests and Complying with HIPAA ... - 0 views

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    Course "Texting and E-mail with Patients: Patient Requests and Complying with HIPAA " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With the recent advances in portable technology, more and more organizations and their users are taking advantage of mobile devices to save time and get work done more efficiently. Texting, portable e-mail, and Apps are revolutionizing the ways health care providers interact with their patients and get their work done. But the use of these devices comes with hidden costs of compliance, especially if they lead to a reportable breach under HIPAA or state laws. HIPAA Privacy and Security Officers have been struggling to keep up with the use of the devices to protect patient privacy and avoid compliance issues. Even if these devices aren't in formal use in your organization, you need to act now to anticipate their use and make sure they are used properly. This session is designed to provide intensive, two-day training in HIPAA compliance as it relates to the use of mobile devices, including how to use them with Protected Health Information, the policies and procedures you need to have in place to use them securely, and how to manage issues of the "BYOD" phenomenon. The session provides the background and details for any manager of health information privacy and security to know what issues to look for with mobile devices, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. The session will be valuable for both newcomers to HIPAA compliance as well as seasoned veterans. HIPAA compliance will be explained and discussed in detail, from the basics through the latest changes and new technology issues, so that the attendee will have a coherent u
Roger Steven

Texting and E-mail with Patients Patient Requests and Complying with HIPAA - 0 views

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    Overview: With the recent advances in portable technology, more and more organizations and their users are taking advantage of mobile devices to save time and get work done more efficiently. Texting, portable e-mail, and Apps are revolutionizing the ways health care providers interact with their patients and get their work done. But the use of these devices comes with hidden costs of compliance, especially if they lead to a reportable breach under HIPAA or state laws. HIPAA Privacy and Security Officers have been struggling to keep up with the use of the devices to protect patient privacy and avoid compliance issues. Even if these devices aren't in formal use in your organization, you need to act now to anticipate their use and make sure they are used properly. This session is designed to provide intensive, two-day training in HIPAA compliance as it relates to the use of mobile devices, including how to use them with Protected Health Information, the policies and procedures you need to have in place to use them securely, and how to manage issues of the "BYOD" phenomenon. The session provides the background and details for any manager of health information privacy and security to know what issues to look for with mobile devices, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. The session will be valuable for both newcomers to HIPAA compliance as well as seasoned veterans. HIPAA compliance will be explained and discussed in detail, from the basics through the latest changes and new technology issues, so that the attendee will have a coherent understanding of not only the rules, but also how to think about compliance and make sound compliance decisions on a day-to-day basis in the context of mobile devices. Agenda Day One Day one sets the stage with an ov
Roger Steven

2016 Update on Physician Compensation and Population Health - Strategies for Implementi... - 0 views

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    Overview: This webinar will focus on the major fraud and abuse laws, including the Stark Law, the Anti-Kickback Statute, and the False Claims Act. In this webinar Mr. Wolfe will provide an overview of the health care regulatory issues related to implementing value-based physician compensation models. Why should you Attend: Given the substantial awards and settlements in recent Stark Law enforcement actions, Stark Law compliance has become more than just a compliance issue: it is an enterprise risk management issue. As medical groups, hospitals, and health systems transition to value-based physician compensation arrangements, they will need to make sure their arrangements continue to be compliant with the Stark Law. Areas Covered in the Session: Provide a general overview of the Stark Law, Anti-Kickback Statute and the False Claims Act. Explain the requirements for compliance with key regulatory exceptions and safe harbors. Compensation and valuation issues unique to the group practice model Discuss best practices when implementing value-based physician compensation models. Summarize the recent changes to the Stark Law for 2016. Who Will Benefit: In-House Counsel Health Care Compliance Officers Health Care Human Resources Health Care CFOs Health Care executives Speaker Profile Joseph Wolfe is an attorney with Hall, Render, Killian, Heath & Lyman, P.C., the largest health care focused law firm in the country. Mr. Wolfe provides advice and counsel to some of the nation's largest health systems, hospitals and medical groups on a variety of health care issues. He regularly counsels clients on a national basis regarding compliance-focused physician compensation and alignment strategies. He is a frequent speaker on issues related to the physician self-referral statute (Stark Law), hospital-physician transactions, physician compensation governance and health care valuation issues. Before attending law school at the University of Wisconsin, he served as a combat engi
Roger Steven

HIPAA Audits for 2016 - How to Prepare for the New Round of HIPAA Audits - 0 views

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    Overview: In this session we will discuss the HIPAA audit and enforcement programs and how they work, and discuss the areas that caused the most issues in prior audits. We will explore what kind of issues and what kind of entities had the most problems, and show where entities need to improve their compliance the most. We will also explore the typical risk issues that lead to breaches of health information and see how those issues may be a target for auditors in the new 2016 audits. We will review the contents of the HIPAA Audit Protocol used in 2012 to show what documentation needs to be on hand should your organization be selected for an audit in the new round. We will present methods for using the contents of the HIPAA Audit Protocol to build your own compliance plan by extracting and updating the contents and relating your compliance activities directly to the questions that might be asked. In this session we will discuss the HIPAA audit and enforcement regulations and processes, and how they apply to HIPAA covered entities and business associates. We will explain the enforcement regulations and the new, increased fines and new penalty levels, including new penalties for willful neglect of compliance that begin at $10,000. We will discuss what information and documentation must be prepared in advance so that you can be ready for an audit at any time, including sample information request forms and questions asked at prior audits. The session will also cover how to know if you may become the subject of an audit or enforcement action, and what you can do to help limit your exposure. We will discuss how most enforcement actions come about and what can be done to prevent incidents that lead to enforcement activity. The HIPAA Privacy, Security, and Breach Notification regulations (and the recent changes to them) and how they will be audited will be explained. Documentation requirements for compliance will be explored and a framework of security policies necessary
Roger Steven

The Drunk, High, or otherwise Impaired Health Care Practitioner: What can be done to Help - 0 views

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    Overview: Health care practitioners and other licensed professionals work in today's diverse, fast-changing, multidisciplinary environment. All licensed professions have higher rates of drug abuse, alcohol abuse, and mental health issues. Yet each individual profession has a unique, though similar, state laws which govern how state licensing agencies take action against the professional so as to protect the public. The state's authority and power over licensed professionals often presents challenges to the impaired practitioner that are not easy to navigate. All licensed professionals must adhere to standards of state law which govern their professional practices and include prohibitions for impaired practice - even impairment along that is apart from any direct professional harm. Complaints that are received and investigated by a state agency leave the licensed professional with an uncertain process to handle the state action against them. Coupled with numerous related consequences, such as loss of employment, family issues and divorce, and criminal actions, the licensed professional must handle all these challenges successfully. Learn to identify and understand varying state laws that apply to allow disciplinary action against the licensed professional, both immediately and temporarily, and those which are permanent and final. Review the most common successful elements of the rehabilitation of the licensed professional faced with the deadly consequences of addiction. Compare and contrast regulatory laws and due process requirements for state action. This allows the licensed professional to avoid career-ending sanctions and to defend successfully against legal actions which may result in ruinous practice and career consequences for the professional. This program offers an objective, thorough review of laws which apply to the impaired licensed professional. Why should you attend: Health care practitioners are faced with a higher lifetime risk of drug abuse,
Roger Steven

Seminar on Supplier Management for Medical Device Manufacturers at Washington, DC - 0 views

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    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
Roger Steven

Medical Staff Bylaws Requirements For Joint Commission Accreditation - 0 views

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    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
Roger Steven

Seminar on Fundamentals of Statistical Process Control: Implementation and Assurance of... - 0 views

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    Course "Fundamentals of Statistical Process Control: Implementation and Assurance of SPC" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This 2-day seminar provides the information you need to use one of the most powerful tools in quality, statistical process control. It will help people in design, quality, and production understand the concepts and effectively implement them. The examples and issues in the seminar come primarily from the medical device industry, but the material is applicable to any production environment. Production process must be controlled to help ensure they are stable. While there are many control methods, the most powerful and often used is statistical process control, SPC. It uses data from the process itself to detect changes - changes that could result from an unstable process. SPC helps determine if a process continues to operate the way it was set up. If not, SPC produces a signal that calls attention to the problem. One very important application is process capability analysis. With a stable process, SPC data can help determine if the process is capable of meeting the product specifications. These are often expressed as process capability indices. Continuous improvement programs can use the information generated by SPC to monitor process variation and identify its causes. These methods can reduce cost, improve product, and enhance customer satisfaction. Why should you attend: Manufacturing companies, especially medical device manufacturers, must control process. Not only is this a regulatory requirement, but is a good business practice. Without a solid understanding of SPC, you put yourself and your company at a disadvantage. On a personal basis, the material in this seminar will help improve your skills; it aligns with the ASQ Body of Knowledge for the Certified Quality Engineer, Green Belt, and Black Belt. These are areas you should master
Roger Steven

The A to Z's of HIPAA Privacy, Security, and Breach Notification Rules- 2 day In pe... - 0 views

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    Course "The A to Z's of HIPAA Privacy, Security, and Breach Notification Rules" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This session is designed to provide intensive, two-day training in HIPAA compliance, including what's new in the regulations, what's changed recently, and what needs to be addressed for compliance by covered entities and business associates. The session provides the background and details for any manager of healthcare information privacy and security to know what are the most important privacy and security issues, what needs to be done for HIPAA compliance, and what can happen when compliance is not adequate. Audits and enforcement will be explained, as well as privacy and security breaches and how to prevent them. Numerous references and sample documents will be provided. Who Will Benefit: * Information Security Officers * Risk Managers * Compliance Officers * Privacy Officers * Health Information Managers * Information Technology Managers * Medical Office Managers * Chief Financial Officers * Systems Managers * Legal Counsel * Operations Directors Agenda: Day One Day one sets the stage with an overview of the HIPAA regulations and then continues with presentation of the specifics of the Privacy Rule, recent changes to the rules, and the basics of the Security Rule Lecture 1: Overview of HIPAA Regulations * The Origins and Purposes of HIPAA * Privacy Rule History and Objectives * Security Rule History and Objectives * Breach Notification Requirements, Benefits, and Results Lecture 2: HIPAA Privacy Rule Principles, Policies and Procedures * Patient Rights under HIPAA * Limitations on Uses and Disclosures * Required Policies and Procedures * Training and Documentation Requirements Lecture 3: Recent and Proposed Changes to the HIPAA Rules * New Penalty Structure * New HIPAA Audit Program * New Patient Rights
Roger Steven

Developing Hospital Billing and Chargemaster Policies and Procedures - 0 views

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    Overview: Hospital chargemasters are complex and represent a key component for the revenue cycle of hospitals. Chargemasters are intertwined with coding for services, billing for services, charging for services and even involve the cost reporting process. A myriad of decisions must be made concerning how the chargemaster is organized, impacts on coding and billing, charge structuring, cost accounting, and other processes within the revenue cycle. Whenever decisions are made, policies and procedures should be developed, approved and implemented. A proper system of billing and chargemaster policies and procedures can help to maintain an appropriate compliance stance in a world where ambiguous guidance is often the norm. The development of charges and charge structuring within the chargemaster is a major issue often referred to as transparent pricing. While even the Medicare program maintains that hospitals should charge for everything, the way in which charges are set and amalgamated at the claim level can vary significantly between hospitals. A key issue for the chargemaster is differentiating separately charging from separately reporting. The way in which hospitals make decisions about the bundling of charges at the line-item level within the chargemaster leads to many decisions, all of which need justification through proper policies and procedures. Due consideration must be given to departmental concerns about revenue generation, cost reporting implications, coding implications and any associate challenges with billing and claims filing. Why should you Attend: See Typical Questions - Here are some reworded marketing questions: Why are the chargemaster and hospital billing targets of compliance audits? How should we prioritize statutory and contractual compliance for the chargemaster and billing process? Will chargemaster and associated billing policies and procedures give us protection relative to compliance? How should we develop a system of chargemaster po
wheelchairindia

Pediatric Wheelchair - 0 views

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    The body size differences are paralleled by maturational changes. The smaller body of an infant or neonate is substantially different physiologically from that of an adult. Congenital defects, genetic variance, and developmental issues are of greater concern to pediatricians than they often are to adult physicians. A major difference between pediatrics and adult medicine is that children are minors and, in most jurisdictions, cannot make decisions for themselves. The issues of guardianship, privacy, legal responsibility and informed consent must always be considered in every pediatric procedure. In a sense, pediatricians often have to treat the parents and sometimes, the family, rather than just the child. Adolescents are in their own legal class, having rights to their own health care decisions in certain circumstances. In basic terms, pediatricians take care of all of the children's needs from emotional support to medical support. Wheelchair india as Pediatric Wheelchair Manufacturers and Pediatric Wheelchair supplier sale at low cost - price, We Sale online Pediatric Powered Wheelchair and Pediatric Electric Wheelchair at wholesale prices...
Roger Steven

A Basic Understanding of Shipyard Workplace Safety - 0 views

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    A Basic Understanding of Shipyard Workplace Safety Shipyard Workplace Safety is a high importance, high criticality area for safety regulation. This is so because shipyards are among the most hazardous of places to work in. it is estimated that at any point of time, the number and incidences of injuries and fatalities in the shipyard industry is at least twice that of the next most hazardous industry, construction. This calls for urgent and important Shipyard Workplace Safety regulations. Present Shipyard Workplace Safety Regulations OSHA has a number of Shipyard Workplace Safety regulations for this industry. These need to be read with CFR Title 29 Code of Federal Regulations (CFR) Part 1915, which not only lay out regulations, but also prescribe codes and methods of implementation of these regulations. Why these two regulations need to be implemented together is that there may be a few hazards not covered by Shipyard Industry standards set out by OSHA. These gaps are covered by the regulations set out in CFR 1915, making these a well-rounded set of regulations for Shipyard Workplace Safety. The need for Shipyard Workplace Safety regulations The need for Shipyard Workplace Safety is acutely felt because of the sheer variety of hazards that present themselves in shipyards. Shipyards, which employ between a few dozen and a few thousand employees each, are a site of potentially serious accidents. Even if accidents do not occur, the very nature of work done at these shipyards can be dangerous and hazardous. Shipyard Workplace Safety is a core requirement that employers in this industry have to keep in mind and put in place. The nature of their work could range from and include any or many of these: Scrapping Demolition Electrical Fabrication Creating large and heavy steel or iron plates, sheets, beams, pipes and related items Soldering Drilling Dealing with propulsion systems Welding Shipyard Workplace Safety has to begin with an understanding of these issue
Roger Steven

Get Ready For Your HIPAA Compliance Audit - 0 views

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    Overview: The webinar will concentrate on topics that HHS has announced will be the focus of the first round of "desk audits". They reflect significant areas of non-compliance revealed in the 2012 pilot audits and HHS HIPAA violation investigations concluded by Resolution Agreements and Corrective Action Plans. They include: HIPAA Risk Analysis Risk Management based on Risk Analysis Breach Notification Notice of Privacy Practices (for Covered Entities) Minimum Necessary Standard Access of Individuals to their PHI Authorizations Workforce Training This webinar is vital because, in focusing on preparation for a HIPAA Compliance Audit, Covered Entities and Business Associates may review, prioritize and structure their HIPAA Compliance programs. If you have HIPAA Compliance documentation ready to submit on two weeks notice to HHS you are implementing an effective HIPAA Compliance program. In addition, every Covered Entity or Business Associate may face an HHS HIPAA Compliance investigation at any time due to a complaint or a Breach. If you are "audit ready" you will be ready for an investigation - and better able to avoid complaints and prevent breaches. Why should you attend: Every Covered Entity and Business Associate is liable - without prior notice - to be audited for HIPAA Compliance by HHS You will have only 2 weeks after receiving your HIPAA Compliance Audit notification and data request to upload all requested documents to an HHS HIPAA Compliance Audit Portal The HIPAA Compliance Audit data request you receive will specify content and file organization, file names and any other document submission requirements Auditors will not contact an audited entity for clarifications or ask for additional information - it is essential that submitted documents are current, accurately reflect the entity's HIPAA Compliance program and demonstrate HIPAA Compliance Only data submitted on time will be assessed Failure to respond on time may be referred to the HHS regional
Roger Steven

Setting up a compliance program in healthcare - 0 views

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    Setting up a compliance program in healthcare: Organizations that set up a compliance program in healthcare should go by many voluntary regulations from the OIG, apart from those mandated by HIPAA. Setting up a compliance program in healthcare is about being compliant with standards. This entails having to be compliant with several standards, which cover a wide variety of areas. There are several voluntary and mandatory guidelines from the Office of the Inspector General (OIG), apart from standards from HIPAA. Setting up a compliance program in healthcare meeting HIPAA requirements is set out and mandated by the Patient Protection and Affordable Care Act (PPACA). Guidelines from the Office of the Inspector General (OIG) The series of compliance program guidance documents from the OIG are largely voluntary, and are meant for the different sections of the health care industry. These include Hospitals Nursing homes Third-party billers, and Durable medical equipment suppliers. These guidelines are issued with the intention of motivating healthcare units to develop and use their own internal controls aimed at helping them adhere to regulations, program requirements and statutes. The OIG issues documents, which act as guidelines for setting up a compliance program in healthcare by providing principles. These need to be adapted when healthcare organizations have to develop their own compliance program that is in tune with their best interests and needs. Another major aim is served in the implementation of these guidelines for setting up a compliance program in healthcare: They help healthcare units to understand the nature of fraud and other risks associated with abuse, when they are setting up a compliance program for their healthcare unit. HIPAA requirements Setting up a compliance program in healthcare while being compliant with HIPAA regulationsrequires a healthcare organization to put in place measures that ensure that health records must: Be confident
Roger Steven

Seminar on Marketing Products without Getting Hammered by FDA at SFO, CA - 0 views

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    Course "Marketing Products without Getting Hammered by FDA" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: With this seminar you will learn how to navigate FDA's legal requirements and its interpretations for enforcement purposes. The agency now applies the principles of cognitive psychology to aid in its determination of what a message really conveys. This becomes a new factor in trying to stay within FDA's legal corral. This conference will provide insight on how to manage your marketing activity and gauge what regulatory risks your business is willing to accept. You will learn how corporate management requires cooperation between marketing, regulatory affairs, legal counsel, manufacturing, engineering and finance departments. You will understand that a weak link in any department leaves the entire corporation vulnerable to FDA enforcement. Most importantly, you will understand the boundaries that FDA uses and how easy it is to cross them. With information from this course, you can step back and rationally evaluate your firm's regulatory profile for advertising and promotion. Why should you attend: If you go "off label" with advertising and promotion, you become embroiled in FDA's advertising and promotion requirements. For devices, the law is weak and lacks legal clarity. For drugs, FDA's law and regulations are extensive and have violated Constitutional protections. Depending on your point of FDA's promotion and advertising requirements can help you or hurt you? There is an inherent conflict in interests. In any case, you need to identify practical criteria to make marketing decisions. That begs the question of whether or not marketing managers and regulatory affairs managers will even try to agree on an issue. FDA's Center for Devices and Radiological Health (CDRH) has never issued a comprehensive guidance on advertising and promotion. You are on your own. CDER has esta
Roger Steven

Seminar on Effective and Efficient Internal and Supplier Quality System Auditing for Me... - 0 views

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    Course "Effective and Efficient Internal and Supplier Quality System Auditing for Medical Devices" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Do you want to understand how to do efficient and effective internal and supplier audits that meet all the requirements of your external auditors, but also add value to your company? Are you confused by all the requirements and guidance documents for medical device quality management systems and are tired of wading through all the regulatory language they contain. This course is for those who will do internal or supplier audits, manage an audit process for these or other company audits. This course will provide you with an easy to understand presentation on the auditing process as well as the requirements you will need to audit under ISO 13485 and the FDA Quality System Regulation (cGMP) Both FDA Quality System Regulation (QSR) and ISO 13485 require that companies do internal audits. However, because the FDA does not look at the content of internal audits, some companies do not get feedback on the true effectiveness of their internal audit system from the FDA during FDA Inspections. ISO 13485 auditors do look at internal audits, but are most concerned that you define a process that meets the requirements of the standard and are following your process. Both require that you define Auditor training is required, but this sometimes just requires reading the company's procedure, although most external auditors will look for more than this. Do you need to train new auditors for yours medical device quality management system or to audit your suppliers? Or do you need to improve the training of your internal and supplier auditors so that they add value to these audits? If you need to do either of these, this seminar will provide this training. In addition to auditing skills and hands-on auditing exercises, this seminar will provide an ove
Roger Steven

New HIPAA Rules - Meeting Requirements for New Patient Rights and New Restrictions on D... - 0 views

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    Overview: New changes modifying the HIPAA Privacy and Security Regulations are going into place to meet the privacy and security mandates within the HITECH Act in the American Recovery and Reinvestment Act of 2009. The changes include establishing new rights for individuals as well as changes to the limitations on uses and disclosures. New requirements for patient access to records and requirements to notify individuals in the event of a breach are only two of the many areas affected in the new law, including new requirements for restriction and accounting of disclosures and increased enforcement activity. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules and all kinds of business associates and their subcontractors will need to establish compliance programs. And if you are required to have a HIPAA Notice of Privacy Practices, you will need to update that to show all the new rights that patients will have, such as electronic copies, new rights to restrict disclosures, and much more. Business associates are now directly covered by the HIPAA privacy and security regulations and are liable for fines and penalties if they do not comply. If a business associate supplies services that interact with the new changes to the rules, the BA will need to be aware of the new requirements. We will explain what a Business Associate needs to do differently under the new regulations. Electronic records have new demands placed on them, in both providing access and in accounting for all disclosures of health information - the electronic age in health care brings new obligations to serve individuals as well as manage health information for healthcare professionals. We will discuss how disclosures must be tracked in an EHR and review the various ways patient records can be supplied electronically. The new regulations will be reviewed and their effects on usual practices will be discussed, as will what policies need to be chang
Roger Steven

Ethics and Laws for Mental Health Professionals- 2 day In person Seminar - 0 views

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    Overview: Mental health care practitioners work in today's diverse, fast-changing, multidisciplinary health care environment. Nowhere but in mental health is there such diversity of clinicians who provide the same or similar services of counseling and therapy. A potential client has a wide choice of mental health providers from whom to choose. Yet each individual mental health profession has a unique education, training, and experience requirement for practice. While similarities exist, requirements differ from state to state and even from profession to profession with a single state. What are these requirements and how do they apply? The state's authority and power over mental health practitioners often presents challenges to these mental health professionals that are not easy to navigate. Differing sources of legal and ethical authority govern each respective health care practitioner in ways that are similar but not the same. Ethics and law are similar, but not the same. All mental health practitioners must adhere to standards of state law which govern their professional practices, including the very core of the doctor-patient relationship. Codes of ethics and state law may both apply to govern the conduct of this clinician. Even some state laws are referred to as ethical codes. Complaints as to alleged misconduct or ethical failings are received and investigated by a state agency and leave the mental health practitioner with an uncertain process to handle and to defend the state action against them. With this background, this seminar empowers the full understanding and application of ethics and laws for mental health practitioners. Learn to identify and understand an ethical framework for a sound mental health practice. An ethical framework is essential to having the right perspective to examine mental health dilemmas. Compare and contrast regulatory laws and codes of ethics to understand their differing applicability. Know the difference between laws and ethics,
wjack1475

Consult For Spine Surgery India: Spine Surgery Overview - 0 views

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    Back issue is a standout amongst the most widely recognized motivations to see a specialist. According to a review, around 80% of individuals experience back torment amid their lifetime. Despite the fact that for the lion's share of these individuals the torment will die down actually without the requirement for surgery, while the staying still require appropriate care and drug or spine surgery to dispose of their back issues.
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