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Courses

  • 41 Request Info

    HIPAA and The IT Manager Webinar

    Overview: This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA Security Rule, in particular portable devices. Areas covered will be texting, email, encryption, medical messaging, voice data and risk factors as they relate to personal devices. I will uncover myths versus reality as it relates to this very enigmatic law based on over 1000 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices.
  • 42 Request Info

    Webinar on What All Providers Should Know About This Emerging Payment Model

    Overview: Bundled Payments are becoming more and more recognized as the preferred method of value-based reimbursement by CMS and several other commercial payers. In this presentation this type of payment method will be explained in detail and real-life examples will be given of how bundled payments actually work. In addition, providers will learn ways to optimize their performance under a bundled payment paradigm and how to negotiate bundled service agreements to their best advantage. Why should you Attend: It is critical for providers to understand the emerging CMS payment models and how these new reimbursement structures affect their organizations. Providers should attend this session to learn how to optimize their performance under a bundled payment paradigm and how to negotiate bundled service agreements to their best advantage.
  • 43 Request Info

    Project Management for Non-Project Managers 2017

    This two-day seminar will begin by laying the foundation for the subject by first defining what a project is and then discussing the unique roles that the project manager must assume along the length of any project. The Triple Constraint, the most fundamental of project management principles, will be explained in detail with examples and tools provided that can be used to integrate the principle into any project management process. Read More : http://www.globalcompliancepanel.com/control/globalseminars/~product_id=900996SEMINAR?trainingregistry-September-2017-SEO
  • 44 Request Info

    Complaints, Adverse Event Reporting, and Recalls - An Integrated Approach 2017

    Medical Device manufacturers operate in numerous regulatory systems that often have different requirements and are not always consistent. The new ISO 13485:2016 emphasizes this problem. Manufacturers must identify their roles, identify the regulatory requirements for that role, and incorporate them into the quality management system. The various jurisdictions, however, deal with post-market device issues in many different ways. The quality management system, QMS, needs three interlocking process: complaint management, adverse event reporting, and recalls. These processes also have supporting QMS processes such as corrective action and design changes. Overarching the QMS processes are the regulatory requirements, usually involving record keeping and reporting. This workshop covers these primary and secondary QMS processes and analyzes them in terms of US, EU, and Canadian regulations.
  • 45 Request Info

    HIPAA Compliance for Small Healthcare Providers 2017

    Being in compliance with HIPAA involves not only ensuring that you provide the appropriate patient rights and controls on your uses and disclosures of Protected Health Information; but that 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. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901282SEMINAR?trainingregistry-November-2017-SEO
  • 46 Request Info

    FDA Scrutiny of Promotion and Advertising Practices 2017

    If you go "off label" with advertising and promotion, FDA's hammer can hit hard and seemingly out of the blue. Advertising and promotion for devices is weak and lacks legal clarity. For drugs, the regulations are prescriptive and guidance documents clamp down on nuances. Marketing and regulatory affairs departments must collaborate to avoid the hammer and penalties of FDA. The roadblock, however is that marketing managers and regulatory affairs managers rarely reach common ground and are loathe to even consult with each other. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901102SEMINAR?trainingregistry-November-2017-SEO
  • 47 Request Info

    Quality by Design using Design of Experiments (QbD) 2017

    This seminar focuses on how to establish a systematic approach to pharmaceutical development that is defined by Quality-by-Design (QbD) principles using design of experiments (DOE). In addition, this course teaches the application of statistics for setting specifications, assessing measurement systems (assays), developing a control plan as part of a risk management strategy, and ensuring process control/capability. All concepts are taught within the product quality system framework defined by requirements in regulatory guidance documents. Using a QbD approach for pharmaceutical development studies should include a systematic understanding of the process and using this understanding to establish a control strategy as part of a comprehensive quality risk management program. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901134SEMINAR?trainingregistry-December-2017-SEO
  • 48 Request Info

    HIPAA - How Business Associates Can Comply Calmly, Confidently and Completely 2017

    HIPAA Rules are easy to follow, step-by-step, once you know the steps. In this seminar Paul Hales will capture your attention with visual presentations, exercises and discussion that explain HIPAA compliance in plain language. And he will show you how to find the exact steps - when you need them - to comply with every topic in the HIPAA Privacy, Security and Breach Notification Rules Key Takeaways: Clear Understanding of the HIPAA Privacy, Security, Breach Notification Rules What they are - How they work together to affect Business Associates and Covered Entities (Health Care Providers, Health Plans and Health Care Clearinghouses) Origin of the HIPAA Rules - How they are changing - What to expect next How the HIPAA Rules affect and specifically apply to Business Associates Specific HIPAA Compliance Requirements for Business Associates Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901390SEMINAR?trainingregistry-December-2017-SEO
  • 49 Request Info

    What is Computerized Testing Systems | GxP Compliance Testing 2018

    Testing is the science of identifying defects, so that they can be corrected, and of demonstrating that a system meets intended requirements. Testing computerized systems is considered a fundamental verification activity and appropriate testing is a regulatory expectation as described in many regulations e.g. EU GMP Annex 11. "Evidence of appropriate testing methods and test scenarios should be demonstrated. Particularly system (process) parameter limits, data limits and error handling should be considered" The regulated company is responsible for demonstrating compliance and fitness for use. Effective testing demonstrates compliance with regulatory requirements and ensures patient safety, product quality and data integrity as a result of controlling identified risks. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901363SEMINAR?trainingregistry-January-2018-SEO
  • 50 Request Info

    Principal Investigator Responsibilities in Clinical Research | GCP 2018

    This seminar is designed to acquaint all Participants with the Rules and Regulations that form the background of what is know as the GCP of Clinical Research. To follow "The Good Clinical Practices" (GCP) is to follow the standard for the design, conduct, performance, monitoring, auditing, recording, analysis and reporting of clinical trails that provides assurance that the data and reported results are credible and accurate and, most importantly, that the safety, rights, integrity, and confidentiality of trial subjects is protected. That all members of the team must know and practice "GCP" guarantees, that the Protocol is followed, that the Informed consent is complete, that the study conduct is according to the protocol, keep enhancing: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901351SEMINAR?trainingregistry-January-2018-SEO
  • 51 Request Info

    HIPAA Compliance Officer Training | HIPAA Professional 2018

    This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2018 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days. I will speak on specific experiences from over 17 years of experience in working as an outsourced compliance auditor, expert witness on multiple HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More importantly I will show you how to limit those risks by simply taking proactive steps and utilizing best practices. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901507SEMINAR?trainingregistry-February-2018-SEO
  • 52 Request Info

    HR Auditing: Identifying and Managing Key Risks

    HR audits are designed to help your organization focus its attention on its human resource management practices, policies, procedures, processes, and outcomes by providing you with a structured and systematic series of questions about key compliance, risk management, internal auditing, and human resource management issues. As a process, HR audits are designed to help your organization identify potential and actual problem areas, help assess the effectiveness of current HR management activities, help assess weaknesses in HR internal control processes, and help assess human capital strategic and compliance related risks. HR audits should additionally provide suggestions for corrective action. Read More: http://www.globalcompliancepanel.com/control/globalseminars/~product_id=901198SEMINAR?trainingregistry-February-2018-SEO
  • 53 Request Info

    Practices for Active Pharmaceutical Ingredients per ICH Q7

    Overview: The APIs covered in this guidance document include new chemical entities and APIs of biological origin and those created by biotech processes. Why should you Attend: This document was created to fulfil the need for specific guidance with regards to GMPs for APIs. Failure to meet these requirements is a significant source of observations during regulatory inspections by FDA or global regulators of manufacturers and/or of sponsors that use contract manufacturers and the contract manufacturers themselves.
  • 54 Request Info

    Structuring and Auditing Non-Physician Practitioner Arrangements Under the Anti-Kickback and Stark Laws

    Overview: In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting NPP arrangements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. Why should you Attend: Prior to moving forward with any NPP arrangements, the parties should carefully evaluate whether the proposed structure and financial terms support compliance with Stark's technical requirements and key tenets of defensibility so they will be prepared to mount a defense in the event the lease is ever challenged. This webinar will focus on the Stark Law's underlying technical requirements and key tenets of defensibility as they apply to NPP arrangements.
  • 55 Request Info

    Take the Fear out of HIPAA - Basic Step-by-Step Compliance

    Overview: The HIPAA Rules are frequently misunderstood and inadvertently violated. However, HIPAA Rules are easy to follow, step-by-step, when you know the steps. This session will explain exactly how a health care provider's designated HIPAA Compliance Official can find the right steps for each HIPAA compliance topic and how the health care provider can review and be assured the practice is up to date and in compliance with the HIPAA Rules. Why should you Attend: HIPAA can be complicated but this session provides practical solutions and answers to everyday problems you can understand. This session covers the HIPAA Privacy, Security, Breach Notification and Enforcement Rule compliance requirements for health care providers in plain language. Using practical, everyday examples Step-by-Step, with PowerPoint presentations and interactive exercises
  • 56 Request Info

    Phase I Investigational Drug Products | USA Seminar 2018

    There are certain requirements in 21 CFR Part 211 that are directed at the commercial manufacture of products typically characterized by large, repetitive, commercial batch production and requirements as a result, are not appropriate to the manufacture of most investigational drugs used for phase I clinical trials. Based on these issues, application of cGMPs to Phase I investigational drug products was exempted from 21 CFR 211. However, based on statutory requirements as given in Section 505(i) of the FD&C Act, FDA issued regulations governing IND products in order to protect human subjects enrolled in clinical trials, specifically with regards to the chemistry, manufacturing and controls data submitted as part of IND applications for drugs or biological products.
  • 57 Request Info

    How to Prevent,Preparefor, and Report Breaches of Healthcare Information

    We will discuss the kinds of threats that exist for PHI and how they're changing as the hackers gain experience and abilities, and why you need to prepare for next-generation attacks now. The HIPAA Breach Notification Rule has been in effect for more than two years now, requiring the reporting of breaches of the privacy and security of PHI, and many organizations are still not prepared to respond to a breach of PHI and report and document it properly. Given that one of the leading HIPAA compliance issues cited by HHS is a lack of incident handling policies and procedures, it is now essential for all covered entities to be prepared for incidents and breaches. We will discuss the origins of the rule and how it works, including interactions with other HIPAA rules and penalties for violations
  • 58 Request Info

    Webinar On Vascular Catheterizations - the Basics

    Overview: This Webinar will help you establish(or re-establish for some of us) a Catheter coding foundation.Beginning with defining the common physician/specialty phrases and words we encounter we will start to understand the building blocks of Selective and Non-selective catheterizations, access sites and laterality as described by the physician documentation.What is included in these codes will be a topic for discussion as will notes or indicators as to other procedures the physician may have performed that are separately billable. The main body of the presentation with provide plenty of "hands-on" practice scenarios including a basic 5 Step Guide to capturing each catheterization code and when to add more than one! As we explore through the Five Catheter Coding Zones, Arterial (upper and lower Diaphragm), Venous, Pulmonary and Portal areas, we will cover 26 common scenarios plus unique coding exceptions to each Zone that you will want to take special note of.
  • 59 Request Info

    How to Examine Critical Regulatory Requirements related to physician Practice Acquisitions

    Overview: In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting physician practice acquisition arrangements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided. Why should you Attend: As health care organizations and physician practices pursue acquisition strategies and transition to more innovative post-transaction models, they must manage their compliance and enterprise risk by ensuring any new arrangements are defensible under the Stark Law.
  • 60 Request Info

    What are the Do's and Don'ts of HIPAA Texting and Emailing

    This lesson will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission. I will go through multiple examples and specific scenarios and also offer simple common-sense solutions. Areas covered will be texting, email, encryption, medical messaging, voice data, personal devices, and risk factors. Price - $139 Contact Info: Netzealous LLC - MentorHealth Phone No: 1-800-385-1607 Fax: 302-288-6884 Email: support@mentorhealth.com Website: http://www.mentorhealth.com/ Webinar Sponsorship: https://www.mentorhealth.com/control/webinar-sponsorship/ Follow us on : https://www.facebook.com/MentorHealth1 Follow us on : https://www.linkedin.com/company/mentorhealth/ Follow us on : https://twitter.com/MentorHealth1