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

Overview: Final regulations for the new HIPAA Breach Notification Rule require much more than notifying individuals affected by a Breach of their Protected Health Information (PHI). Covered Entities and Business Associates first must follow and document a very specific process to determine if a Breach occurred. If no Breach occurred documentary proof must be kept for six years. If a Breach did occur timely notifications and other actions must be undertaken and documented. This webinar will explain: What Covered Entities and Business Associates must do to comply with the Breach Notification Rule What is and is not a Breach Three exceptions - when an acquisition, access, use, or disclosure of PHI not permitted by the Privacy Rule is not a Breach How to perform a Breach Risk Assessment to determine if you can demonstrate a a low probability that the PHI was compromised Who must be notified in case of a Breach When notifications must be provided What information must be contained in each notification Other requirements in case of a Breach Investigate Mitigate harm to affected individuals Protect against further Breaches Document everything Planning and preparation for the worst - public relations and mitigation strategies to limit damage to the organization's reputation and financial well-being Why should you attend: Breaches and incidents that might be Breaches happen all the time! More than 173,000 separate breaches of Protected Health Information (PHI) affecting less than 500 individuals were reported to the U. S. Department of Health and Human Services (HHS) between September, 2009 and May 31, 2015 and in the same period HHS received approximately 1240 reports of PHI breaches that affected 500 or more individuals An acquisition, access, use, or disclosure of PHI not permitted by the Privacy Rule is presumed to be a Breach unless it falls within an exception or the Covered Entity or Business Associate can demonstrate a low probability that the PHI was compromi

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

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

Course "New HIPAA Audit and Enforcement Activities: Being Prepared to Show your Compliance " has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: We will be discussing the history and evolution of HIPAA Privacy/Security and the major points you need to understand to proactively protect your practice or business from the imminent federal auditing process: * History of HIPAA * HITECH * HIPAA Omnibus Rule * How to perform a HIPAA Security Risk Assessment * What is involved in a Federal audit and how is it conducted * Risk factors for a federal audit * How to avoid a Federal audit * Business Associates and HIPAA audits * EHR and HIPAA * Business Continuity/Disaster Recovery Planning * Assessing your contractors and sub-contractors * In depth discussions on IT down to the nuts and bolts * Risk factors that can cause an audit (low hanging fruit) * New rules which grant states ability to sue citing HIPAA on behalf of a patient * New funding measures Why should you attend : The evolutions of this enigmatic law and how what was once relative benign in terms of enforcement is now fully funded and aggressive. Learn what you can do to be prepared for an audit and how to lower risks of ever being audited. It is absolutely imperative that you are proactive and not reactive with your compliance program, this is a necessary evil and you need to protect your practice or your business and limit risks from the imminent Federal audits. Join me in keeping up with this very confusing law and take advantage of all the templates and information provided as part of the seminar. Areas Covered in the Session: * HIPAA -Brief History * HIPAA Privacy Rule vs HIPAA Security Rule * HITECH Act * Breach Notification Rule * Omnibus Rule and audits * Business Associates and audits * Current Court Cases (precedence) * Paper Based PHI Concerns and how to lower risk

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

Course "HIPAA for the Compliance Officer" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: I will be going into great detail regarding you practice or business and how it relates to the HIPAA Security/Privacy Rule, Areas covered will be history of HIPAA, privacy vs security, business associates, changes for 2016, audit process, paper based PHI, HIPAA and suing, texting, email, encryption, medical messaging, voice data and much, much, more I will uncover myths versus reality as it relates to this very enigmatic law based on over 600 risk assessments performed as well as years of experience in dealing directly with the Office of Civil Rights HIPAA auditors. I will also speak to real life audits conducted by the Federal government (I've been on both sides of these audits) what your highest risks are for being fined (some of the risk factors may surprise you). In addition, this course will cover the highest risk factors for being sued for wrongful disclosures of PHI and the manner in which patients are now using state laws to sue for wrongful disclosures. Don't always believe what you read online about HIPAA, especially as it relates to encryption and IT, there are a lot of groups selling more than is necessarily required. Why you should attend: This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur. It will also address major changes under the Omnibus Rule and any other applicable updates for 2016. 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 HIPAA cases, and thoroughly explain how patients are now able to get cash remedies for wrongful disclosures of private health information. More im

Overview: Section 13411 of the Health Information Technology for Economic and Clinical Health (HITECH) Act, requires Health and Human Services (HHS) to conduct periodic audits of providers and business associates to ensure their compliance with the HIPAA Security and Privacy Rule, and breach notification standards. To implement this mandate, the Office of Civil Rights (OCR) has conducted HIPAA/HITECH audit program with KPMG of 115 health care organizations to assess privacy and security compliance. This webinar will focus on the implementation and tracking of HIPAA audit best practices in a healthcare setup in order to prepare for the federal audit using published OCR audit protocols. Every audit begins with interviews, a questionnaire, and a thorough policy and procedures review. Presenter, with his decades of knowledge in the compliance, legal, auditing and security areas, will walk the attendees through the audit process, documentation requirements, and implementation specifications of the HIPAA privacy, security and breach rules. This presentation not only provides opportunity for the participants to prepare for the federal HIPAA audit but also to improve the security posture of their organizations by adopting to changing technology (mobile, social media, Health Information Exchange(HIE), cloud services, etc.) and threat landscape perspective as well. This presentation will uncover reasons why many health information breaches are occurring and help organizations better secure and comply with electronic protected health information by meeting the required and addressable HIPAA/HITECH security rules. The presenter will also share the best practices used for HIPAA security implementation and continuous risk assessment which is considered as "due diligence" by auditors for the HIPAA security compliance program. Areas Covered in the Session: Healthcare Technology Adoption/Trends Healthcare Regulatory (HIPAA/HITECH) and OCR/HHS Audit Overview Differences between

Overview: Remember spaghetti code? The HIPAA breach area is now almost as convoluted and overlapping and confusing as spaghetti code. Sometimes you think you are both coming and going at the same time when you think through an event to determine if your organization has had a breach. For example: Is a security incident always a beach? Is an ePHI breach a security incident as well? Is a cybersecurity event always a breach? What if it does not steal any clinical information, diagnoses or procedures information, or any payment information? A security incident? Or both? Are all the necessary kinds of notice in the Breach rule? What is Cybersecurity Insurance? Is it really the finger in the dike or itself full of Swiss cheese? Can the loss of patient or member data be a HIPAA breach and identity theft plus a fraud issue? Why should you Attend: HIPAA breaches now number in the multiple thousands, if not multiple millions. Your organization needs to be prepared for the initial sense of panic, a complete investigation, and the federal, state and reputational costs of a mega breach. A breach now costs in money approximately $225/record. And this does not include any fine of any type. The loss and theft of 1000 records may cost you organization from a quarter to $1 M, or more, and 6 months to a year to resolve. You need to know the basics of what PHI and ePHI really are; what puts the event into the breach safe harbor, what breach exceptions keeps the event out of OCR's hands, what the 4 factors are and how they are used. You need to know that your organization's breach plan and your policies and procedures include the need to notify when necessary the police, the FBI and other state and federal organizations beyond the Office for Civil Rights. Your organization needs to know how to protect itself after the fact by considering Cybersecurity Insurance. Areas Covered in the Session: Definition and reporting of a Security Incident Definition of a breach Breach Guidance Br

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

The federal Health Insurance Portability and Accountability Act (HIPAA) was legislated in 1996 with the primary aim of ensuring that employees who are in the process of changing or leaving their jobs do not lose their health insurance benefits. Additionally, HIPAA sought to bring down health care fraud and abuse by mandating pan-industry standards for the protection of health care information and automated billing and other related processes, and for ensuring the security of Protected Health Information (PHI). What is a HIPAA Security Audit? A HIPAA Security Audit is a program under the HIPAA Privacy, Security, and Breach Notification Audit Program of the Office of Civil Rights (OCR). A HIPAA Security Audit is carried out to make sure that the policies, processes and controls on the part of Covered Entities comply with the provisions of the HITECH Act of 2009. Adherence to the requirements laid out by HITECH is mandatory. Given the high degree of continued use of new technologies that go into and will continue to go into electronic records of patients and the criticality of the data contained in them; the US Department of Health and Human Services (HHS) recognizes that there could be chances of data breach of Protected Health Information. It is to prevent the occurrence of these breaches that a HIPAA Security Audit is mandated by the HITECH Act. Reporting of data breaches is mandatory The foremost highlight of the HITECH Act is the requirement that Entities covered by HIPAA report data breaches that affect 500 or more employees to the HHS. The OCR lays out an Audit Protocol, with whose policies, protocols and processes a facility has to comply if it is said to be compliant with the HIPAA Security Audit. Why is it necessary to carry out a HIPAA/HITECH Security Audit? Compliance with HIPAA Security Audit is necessary to demonstrate that a practice or business is well protected. The most important reason for which such entities need to be HIPAA/HITECH Security

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

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

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