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Overview: This webinar will cover everything that you need to know about how to handle HIPAA security incidents, breaches, and complaints and the Department of Health and Human Resources Investigations thereof. Not all security incidents are breaches, but all breaches of confidentiality are within the broad ambit of security incidents. Privacy rule violations, such as failing to give a patient a copy of his or her medical records, may also constitute a breach as the $4.2 million fine assessed against Cignet Healthcare of Prince George's County, Maryland, dramatically proved. Handling an investigation properly is key to determining not only how to handle it to mitigate any harm and to take action to prevent it from happening again but also to determine whether it is reportable to affected individuals and to DHHS. HIPAA requires a complaint procedure (policy). The webinar will suggest what such a document should contain as it also will for the required report procedure (what is reportable, who reports, to whom, and required/suggested contents of the report) and the required response procedure (what do the responsible officials do after receiving the report or the complaint). Investigating a possible security incident is key. The webinar will cover how to conduct a thorough investigation of HIPAA security incidents, breaches, and patient complaints. Finally, the second largest HIPAA civil money penalty or settlement, $4.2 million, was in large part due to the offender's failure to cooperate with the DHHS investigation. The presenter has successfully defended his clients in seven such investigations and knows how to respond to them to avoid or minimize liability. Think of a gap analysis as an examination of: What you currently have in place for HIPAA compliance. Is that adequate? Can it be done better? Is it enough? And what am I missing? Asking these questions will help establish the direction and next steps to take. It lays the ground work for a good Risk Analy

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 understanding the fundamentals of a HIPAA and how you will be required to demonstrate your organization's compliance program. If your healthcare practice, business, or organization needs to understand how to be prepared for an increase in HIPAA enforcement and make sure your current safeguards are adequate and can withstand government scrutiny, please join us for this informative and interactive course. Why should you Attend: BAll most 120,000,000 individuals were affected by HIPAA data breaches in 2015. This is a significant reason why Congress has inquired about the recent and very sizeable increases in cyber-attacks that inflect the risk of medical identity theft. The HHS Office for Civil Rights not only are conducting audits but is looking to increase HIPAA enforcement. Attendees will leave the course clearly understanding of all the requirements that must be in place for HIPAA and how to demonstrate compliance if audited. After completing this course, a Covered Entity or Business Associate will be able to know what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session: Why was HIPAA created? What are the HIPAA Security and Privacy Rules? What is a HIPAA Risk Management Plan? What is meant by "Required" and "Addressable" Implementation Specifications? What are Administrative, Technical, and Physical Safeguards Requirements? What is a HIPAA Risk Assessment? What are HIPAA training requirement

Overview: Many infectious diseases were historically confined to specific geographical regions. However, some now pose global threats due to ease of travel, globalization of trade and commerce and global warming. Government Agencies, non-Profit Organizations, Philanthropic groups and others are also funding vaccination programs for regions where infectious diseases are endemic and to deal with new outbreaks.. Such developments are stimulating research in and the development of improved vaccines, their manufacture and control. Supply Chain complexities and stability issues need to be addressed to cope with transport of vaccines to and their use in climatically hostile regions. Programs to address such challenges need to be implemented, being resourced by appropriately trained and qualified staff from a number of disciplines. Development programs for immuno oncology products also require staffing by similarly skilled professionals. Workers currently engaged in Discovery, Development and Manufacture of conventional medications , or those seeking career-change opportunities can develop an understanding of the concepts, constraints and opportunities associated with Vaccine products by attendance at the Webinar. Engineering professionals involved in facility construction, or repurposing can also benefit as can Regulatory Affairs Professionals or staff at medicines Evaluation Agencies. The subject matter is particularly suited to professionals who are expert in the various disciplines associated with conventional medications ("so-called "small molecules") who wish to expand and develop their skills by involvement in vaccine-related programs including immuno-oncology. Areas Covered in the Session: History of and development of vaccine concepts. undamentals of vaccination Vaccine Types Administration of Vaccines Future Concepts Immuno-Oncology Vaccine Manufacture Who Will Benefit: Regulatory Affair Managers Project Management Personnel QA Managers Scientists Technol

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 organization needs to understand the role of the HIPAA Security Official, the requirements, and make sure the current compliance program is adequate and can withstand government scrutiny, please join us for this informative and interactive course. Why should you Attend: The role of the HIPAA Security Official is critically important in complying with the HIPAA Security Rule. Besides being responsible for many of the daily operations within an organization, the Security Official is tasked with managing the HIPAA compliance program. Knowing what is required is part of the Security Official's duties. Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and to make sure on organization has the proper policies and procedures in place. After completing this course, a HIPAA Security 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? Who Must Comply with HIPAA Requirements? What are the HIPAA Security and Privacy Rules? The Role of the HIPAA Security Official What is a HIPAA Compliance Program? What is a HIPAA Risk Management Plan? What is meant by "Required" and "Addressable" Implementation Specifications? What are Administrative, Technical, and Physical Safeguards Requirements? What is a HIPAA Risk Asses

Overview: Upon completing this course participants will leave with a preliminary preventive control implementation plan and will: * Understand US FDA final rules for the Preventive Controls for Human and Animal Foods * Define and review your current system to identify gaps in your preventive controls planning. * Be able to develop and implement a valid preventive control company food safety plan to close any gaps * Write and implement appropriate procedures. * Know your requirements for control over your supply chain * Be able to plan and implement HARPC * Be able to perform environmental monitoring * Know how cross contamination can impact your preventive control plan * Know the difference between validation and verification * Understand and be able to use statistical process controls basics * Be able to plan and implement a team approach to preventive controls * Be able to help your food importers to jump through FDA hoops * Develop a system to risk rank your suppliers * Have a plan in hand that will pass any validation check for preventive controls * Understand some of the technology and costs that can help you establish preventive controls * Prove that your system actually prevents food safety problems * Be able to document and report results to upper management, external food safety auditors and FDA auditors * Save your company money Establish simple, low cost complete data collection and reporting systems. * Establish teambuilding between food safety and quality personnel to develop and implement changes to your current system * Understand food safety, security and recall responsibilities in light of cargo theft, adulteration and temperature failures * Learn how to use your system to get some ROI and improve your marketing position * Review current and future technologies designed to improve and simplify data collection * Establish a completely documented system Why should you attend: Validation of preventive co

Overview: This webinar will explain the details of how to report and what to report on the OSHA Injury and Illness report. It will include an explanation of how to determine if an injury is work related, if an injury is new or ongoing, and what the differences are between first aid and medical treatment. A specific list of what constitutes injuries, illnesses and first aid treatment will be provided, along with practical examples of how to determine if an injury should be reported. In addition, examples of the forms used to report injuries, as well as annual summaries will be presented. Why should you attend: OSHA Injury and Illness Record keeping provides a window for regulators to see into your business to determine if the work environment is safe or if there are problems. Correct reporting of injury and illness data and a clear understanding of what to report and how to report it is a key necessity to avoid potential inspections and fines. Areas Covered in the Session: Injury and Illness reporting Determination of workplace relatedness Differences between first aid and medical treatment Determination of case as new or ongoing How to count total lost days Advantages that a company can provide to reduce risks of inspections and fines Who Will Benefit: Safety Personnel HR Personnel Managers Executives Speaker Profile Kenneth S. Weinberg is an independent consultant in environmental health and safety. Dr. Weinberg has consulted for several companies in the areas of OSHA Injury and Illness reporting, as well as auditing for OSHA inspections. He has worked as the Director of Safety at Mass. General Hospital in Boston for almost twelve years, and has written several books on the topics of health care safety, OSHA, and Indoor Air Quality. He has also written several articles for prominent national safety publications, and serves on the editorial advisory boards for safety publications. He Also has been Administrator of the Health Care Divisio0n of the American Socie

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 understanding the fundamentals of a HIPAA compliance. If your healthcare practice, business, or organization needs to understand what is required to protect health records or make sure your current safeguards are adequate and can withstand government scrutiny, please join us for this informative and interactive course. Why should you Attend: With a substantial increase HIPAA data breaches, organizations must understand the requirements to safeguard protected health information. Attendees will leave the course clearly understanding of all the requirements that must be in place for protecting the health records their organizations maintain, create, transmit, or store. After completing this course, a Covered Entity or Business Associate 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? Who Must Comply with HIPAA Requirements? What are the HIPAA Security and Privacy Rules? What is a HIPAA Risk Management Plan? What is meant by "Required" and "Addressable" Implementation Specifications? What are Administrative, Technical, and Physical Safeguards Requirements? What is a HIPAA Risk Assessment? What are HIPAA training requirements? What is a HIPAA data breach and what happens if it occurs? What are the penalties and fines for non-compliance and how to avoid them? Creating a Culture of Compliance Questions Who Will Benefit: Compliance Of

Overview: During the webinar Participants will be addresses on the key regulatory provisions for cosmetic products in the major global economies. The EU's new Cosmetic Product Regulation (EU CPR) will be given a certain, wider position as the EU CPR is representing the latest, most modern regulatory framework which is influencing other global legislators. For the regulations of the USA, Canada, China, Japan, South Korea, Taiwan, ASEAN, India, Brazil, Mercosul/Mercosur and Russia, a general introduction into the key provisions will be given. Some specific difficulties arising from the existing discrepancies in the global frameworks will be depicted. Areas Covered in the Session: The new EU Cosmetics Regulation Basis principles and provisions Experiences and obstacles from the implementation phase Options for compliance approaches and available supporting tools Remaining issues and future perspectives and activities Cosmetics Regulations in Asia China & Hong Kong South Korea Japan Taiwan The ASEAN Cosmetics Directive India Russia Cosmetics Regulation in the Americas - Existing Global Discrepancies and International Harmonization Attempts USA Canada Mercosur / Mercosul South Africa Existing Global Discrepancies Harmonization Attempts The Intern. Cooperation on Cosmetic Regulation (ICCR) Who Will Benefit: Business Owners Managers in manufacturing New staff in manufacturing QA Administrative Managers Regulatory Compliance Associates Customer Service Speaker Profile Dr. Annelie Struessmann is Technical Director with CONUSBAT, a provider of internationalization services for the Fine Chemicals, Cosmetics & Life Sciences Industries: www.conusbat.com. She joined the firm in 2003 and established the service area of regulatory affairs where she is focusing on the European regulatory frameworks for cosmetic products and for chemicals (REACH). The service spectrum includes dossier preparation, safety assessments, registrations, notifications and direct representations, etc. S

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);

What is HIPAA ? Compliance with the Health Insurance Portability and Accountability Act (HIPAA) is a core requirement of the stakeholders involved in health information. HIPAA has prescribed standards with which to protect critical data relating to patients. Electronic Health Records (EHRs) are important documents that contain sensitive patient data, and are thus considered Protected Health Information (PHI). Since this data is accessible to a number of players involved in the field of healthcare; it extremely important to set regulatory guidelines aimed at ensuring that patient information remains protected. HIPAA compliance is essentially about staying in compliance with these guidelines. Measures needed to show compliance with HIPAA HIPAA requires a healthcare organization dealing with PHI to implement all of the following measures and comply with them: Physical measures Network measures, and Process security measures The role of HIPAA Privacy Rule and HIPAA Security Rule HIPAA has set out two important rules that pertain to compliance. These are the HIPAA Privacy Rule and the HIPAA Security Rule. While the Privacy Rule relates to how the medical information of a patient is saved, accessed and shared; the Security Rule is about how to implement national security safeguards for protecting electronic PHI, or ePHI. Who all need to be HIPAA compliant? Since the aim of HIPAA compliance is to ensure complete safety of patient data, it has requirements for every stakeholder in the EHR process. These stakeholders comprise: Covered Entities (CE): Anyone involved in the treatment, payment and operations in healthcare Business Associates (BA): Any person who has access to patient information and is involved in supporting treatment, payment or operations. These include third-party administrators and private sector vendors Those with whom BA's work, or those that are called subcontractors Hosting providers. These typically include healthcare software pro

Overview: As defined by the Health Information Portability and Accountability Act (HIPAA), a Business Associate can be any organization or person working in association with or providing services to a Covered Entity who handles or discloses Protected Health Information (PHI) or Personal Health Records (PHR). With certain exceptions, a person or entity that creates, receives, maintains, or transmits PHI for a function or activity regulated by the HIPAA Privacy Rule for a Covered Entity is a Business Associate. The HITECH Act, a recent update made to overall HIPAA regulations require Business Associates to comply with HIPAA mandates regarding the handling and use of health information. As a Business Associate you must comply with a wide-range of regulatory obligations, including certain privacy obligations, security standards, and breach notification requirements. If your business needs to understand what it means to be a Business Associate and know what required safeguards, policies and procedures must be in place or make sure your current compliance program is adequate and can withstand government scrutiny, please join us for this informative and interactive session. Why should you Attend: There is a lot of confusion about the role and requirements of being a Business Associate. Organizations must be prepared prior to entering into these contracts for services as a vendor and subcontractor. Attendees will leave the course clearly understanding of all the requirements that must be in place for the Business Associate - Covered Entity arrangement. After completing this course, a Business Associate will have a clear understanding as to what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session: Why was HIPAA created? Who Must Comply with HIPAA Requirements? What are the HIPAA Security and Privacy Rules? What are the Consequences of being a Business Associate What is a HIPAA Compliance Program? What is a HIPAA Risk Mana

Dealing with Medicare and Medicaid Overpayments : Medicare and Medicaid overpayments are pretty common. If they are not dealt with properly, they invite penalties. Medicare and Medicaid Overpayments happen when a person, provider or supplier receives a payment that is in excess of the amount due to him or her under Medicare statutes and regulations. This overpayment becomes a federal debt that is owed by the individual to the State. So, Centers for Medicare and Medicaid Services (CMS) is required by federal law to recover this amount. Overpayments routinely occur in Medicare and Medicaid. Many a time, these are unintended and are usually a result of oversight, but could also happen due to intent. Some of the most common reasons for which Medicare and Medicaid overpayments occur can be when: Duplicate submissions of the same service or claim are made Excessive or non-covered services are billed or furnished for billing Services that are not necessary medically or are excluded are paid for The wrong payee gets paid. How are Medicare and Medicaid overpayments processed? Obamacare has amended the federal False Claims Act (FCA), which is part of the Fraud Enforcement Recovery Act of 2009 (FERA), to add provisions relating to recovery of Medicare and Medicaid overpayments. This is how the process of Medicare and Medicaid overpayments works: Whenever Medicare comes to know that any overpayment of $10 (raised to $25 from July 2014) or more is made, it directs the Medicare Administrative Contractor (MAC) to initiate the process of recovery of this overpayment. The MAC starts the process by initially mailing a demand letter in which repayment is requested If no action is taken, a second and third demand letters are mailed in a month following the first one. Contents of a demand mail from Medicare/Medicaid: The demand letter sent by the MAC will explain the details of the Medicare and/or overpayment. When repayment is not made in full within 30 days, interest starts get

Course "Internal Auditing for the Medical Device Industry" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: This course provides an overview of internal auditing requirements and techniques for medical device companies as a method for risk management and quality improvement. The course will cover auditing requirements, audit planning, preparation, knowledge, auditor skills, interviews, documents and records review, objective evidence, audit report writing and corrective action. Why should you attend: Attendees should attend this seminar for risk management and improvement purposes to identify weaknesses, problems, compliance risks, and improvement opportunities. Who Will Benefit: * Quality Manager * Quality Associate * Quality Engineer * Quality Technician * Regulatory Associate Agenda: Day One Lecture 1: Overview of an auditing program, principles of quality management systems and how they related to auditing, benefits of auditing, and what is auditing. Lecture 2: Types of audits, auditor qualifications, ethics, responsibilities, audit phases, audit planning, and scheduling. Lecture 3: Conducting audits, interview techniques, objective evidence, data collection, tracing, use of checklists, and reviewing documents and records. Lecture 4: Conducting process audits, running closing meetings, audit report writing, corrective actions, and improvement Day Two Lecture 1: Overview to auditing to ISO 13485 and FDA QSR. Global differences which affect auditing approaches, auditing document control and record keeping, management responsibility, and resource management. Lecture 2: Auditing order handling, design control, purchasing, and supplier controls. Lecture 3: Auditing production, validation, and preservation. inspection and testing, control of test equipment, customer property, and sterilization Lecture 4: Auditing customer feedback, internal auditing programs, complaint

Overview: Safe hospital care in neither a science nor an art. It is a practice just like the practice by a doctor who combines hindsight of experience and foresight of imagination to come up with an outsight of the best interventions and best protocols. Over time the doctor standardizes the process but is vigilant to any unique requirements of each patient. Such an approach in patient safety is called hazard analysis and mitigation process. This webinar goes a big step farther. It covers innovation strategies to assure that the safety improvements result in a high return on investment and high value to the hospital, and protects the patients. Why should you Attend: About 400,000 patients die each year from hospital mistakes according to a senate hearing. Evidence based methods to reduce adverse, sentinel, and never events are available and successful in aerospace, nuclear, and chemical industries. Why not use them? We need a paradigm shift. We need it in a hurry! You cannot cross the sea merely by standing and staring at the water. Do not be afraid to take a big step if one is indicated. No noble thing can be done without risks Areas Covered in the Session: The Etiologies of Unsafe Care Sufficient Understanding is a Pre-requisite to Safe Care Preventing "Indifferencity" to Enhance Patient Safety Continuous innovation is better than Continuous Improvement Innovations Should Start with Incidence Reports Hazard Analysis Fault Tree Analysis-the Best Tool for Harm Prevention Doing More with Less is Innovation Re-Invent Quality Management Human Errors may be Unpreventable, Preventing Harm is an Innovation Managing Safety: Lessons from Aerospace Protect Patients from Dangers in Medical Devices The Paradigm Pioneers Aequanimitas,The Best Known Strategy for Safe Care Who Will Benefit: Hospital senior management Hospital administrators Doctors Nursing staff Clinical engineers Radiology staff Infection control staff Patient advocates Speaker Profile Dev Raheja

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,

Overview: Discussions, presentation, and webinars regarding HIPAA regulations are usually addressed from the perspective of what the regulations entail, the necessity of compliance with the regulations, and the consequences of willful neglect or non-compliance. This presentation addresses HIPAA regulations from a different perspective - from a personal perspective - from the perspective of the person in charge of moving an organization or facility toward full compliance with HIPAA. The by-product of this presentation will be both an understanding of, and a detailed job description for, a position mandated in the regulations - the HIPAA Security/Privacy Officer. Why should you attend: The HIPAA regulations are numerous, complicated, often vague, and affect every person working in a healthcare facility. Compliance with HIPAA will require a unique individual to lead the charge - an individual whose education, background, experience, and demonstrated skill sets offer the opportunity for that person to succeed in achieving the goals of that position. This is a new position to most healthcare facilities. So understanding who this person should be, what is required of the person with this job title, and with whom this person will interface is vital to every healthcare organization with the goal of achieving full compliance with HIPAA. Areas Covered in the Session: Position goals Position requirements (education, experience, skill sets, etc.) Position responsibilities Stay abreast of regulations Initiate compliance with HIPAA (according to regulations) Ensure continuous progress toward full compliance Develop appropriate security/privacy policies & procedures Oversee and deliver appropriate training programs to all employees Track compliance with HIPAA regulations at the facility & individual levels Track access to PHI Investigate and resolve HIPAA violations Apply sanctions to HIPAA violators Manage any information security personnel Prepare a department budget Hold Bu

Overview:   Institute for Healthcare Improvement (IHI) defines reliability as "failure-free performance over time2". This is simple enough to be understood by anyone. The aim is to have no failures over an extended time period in spite of variability in the patient environment. spite of variability in the patient environment.  This is in line with the technical definition of reliability as the probability of successful performance of intended functions for a specified length of time under a specified user (patient) environment. In a system where the severity of consequences is high, such as in hospitals, the goal is to achieve reliability as close to 100% as possible. This is called failure-free performance. Some hospitals have achieved this goal for specific medical procedures for several quarters. Can they extend this performance over years instead of quarters? That is the challenge we need to face and find elegant solutions zero mistakes or find a way to protect patients if a mistake cannot be prevented.  Why should you Attend: The failures of the U.S. healthcare system are enormous considering the severity of failures. As much as 400,000 patients die each year from hospital mistakes. Another 2.1 are harmed from nosocomial infections (infections acquired during hospital stay). The cost is in billions. Discussions with doctors show that there is reluctance to apply reliability principles to healthcare systems because the variability in healthcare is enormous compared to the aviation and industrial fields. Each customer (patient) is different and each illness is unique in its own way. Then there are interconnecting systems such as cardiology, gynecology, gastroenterology, emergency medicine, oncology, and patient data from various doctors, pagers, computers, vendor software, and intensive care, each operating independently most of the time. But good approaches to improving the system reliability have been tried and tested in many industries. There is a

Overview: In 2013, The US Department of Health and Human Services made major changes to rules implementing The Health Insurance and Portability Act of 1996 (HIPAA) and Health Information Technology for Economic and Clinical Health Act of 2003 (HITECH). Among the many areas impacted by these rules (billing, marketing, research, IT security, etc.) is fund raising. The amendments significantly modify the methods and practice that hospitals, their institutionally related foundations, and other healthcare charities may or must employ when using ANY patient or client information for fund raising. The webinar will cover how to effectively implement the fund raising regulations in a manner that increases both opportunities for philanthropic support and compliant implementation of the new mandates. The rules include specific operational requirements, some of which prohibit protocols that were required under the original HIPAA regulations. The "magic words" mandated by HIPPA-related regulations changed in multiple areas. The webinar will cover all of these areas to ensure your organization is both legally compliant and operationally effective. The types of information that may be used for fund raising changed significantly. This presents numerous substantial fund raising opportunities, as well as challenges on the use and storage of such information. Among other areas to be presented are The required method for individuals to opt-out of receiving fund raising communication The methods of informing patients and clients of their right to opt-out from receiving fund raising communication The broadly expanded types of fund raising communication subject to opt-out rights How providers, hospital, and related fund raising foundation apply an opt-out election by an individual The type of patient and client information that health charities may use for fund raising The contents of provider's Notice of Privacy Practice How clinicians can assist both their patients/clients and the

Overview: The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry. The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act. Why should you Attend: Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public. Areas Covered in the Session: Purpose of the Sunshine Act Who is required to report under the Sunshine Act? What is reported? Exclusions Tracking Penalties Useful links Who Will Benefit: This webinar will provide valuable assistance to all personnel in: Human Subjects Research Healthcare interested in exploring the field of Clinical Research Clinical Research Coordinators Principal Investigators/Physicians Administration in charge of Clinical Research Regulatory Compliance Speaker Profile Sarah Fowler-Dixon is Education Specialist and instructor with Washington University School of Medicine. She has developed a comprehensive education program for human subject research which has served as a model for other institutions. She crafted budgets, policies, procedures, reporting, and training for the new program. She has initiated the planning, development, authorship and implementation of many human subjects research policies, practices, guidelines, submission and reviewer forms often working with state and federal authorities. She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fu

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 or office manager 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 course.  Why should you Attend: The practice or office manager is the backbone of any healthcare office. Besides being responsible for many of the daily operations within an office, the practice manager is often tasked with managing the HIPAA compliance program. Knowing what is required is critically important.  Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and to make sure the practice has the proper policies and procedures in place. After completing this course, a practice or office manager 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? Who Must Comply with HIPAA Requirements? What are the HIPAA Security and Privacy Rules? The Role of the HIPAA Security and Privacy Official What is a HIPAA Compliance Program? What is a HIPAA Risk Management Plan? What is meant by "Required" and "Addressable" Implementation Specifications? What are Administrative, Technical, and Physical Safeguards Requirements? What is a HIPAA Risk Assessment? What are HIPAA training requirements?