Group items tagged

OSHA's Standards on Fire Protection in the Workplace : When it comes to Fire Protection in the Workplace; there are several guidelines to be followed. One could go by common sense, but it is not usually sufficient, which is why OSHA has standards relating to Fire Protection in the Workplace. Like it does for all its safety requirements; OSHA requires the employer to take obligatory steps for the protection of employees from fire. These are covered in Title 29 of the Code of Federal Regulations Part 1910 Subparts E and L; and Part 1926 Subparts C and F. Employer obligations are the core of Fire Protection in the Workplace Requiring employers to carry out roles during a fire emergency and training employees towards the same are the foundation of OSHA standards on Fire Protection in the Workplace. Training employees on OSHA's standards on Fire Protection in the Workplace entails training them on all the core areas of handling a fire: The ways of using fire exits The ways of using fire extinguishing equipment The ways by which to organize an emergency exit plan The ways of using fire exits: Fire Protection in the Workplace on fire exits involves having to put in place a well-designed exit route for employees, so that they escape during a fire easily. These should be done keeping in mind the structure of the building. Keeping the exit route free of obstacles is another important requirement of OSHA's standards on Fire Protection in the Workplace. The ways of using fire extinguishing equipment: Having portable fire extinguishing equipment is not mandatory for OSHA, but employees must be properly trained on their use, should an employer have one. These equipment have to be placed at a convenient location for everyone to access easily. The ways by which to organize an emergency exit plan: An emergency exit plan is required as part of Fire Protection in the Workplace for some kinds of employers. It is for those whose activity involves the heavy use of hazardous chemica

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

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

Overview: This lesson is going to get back to the basics using multiple real life scenarios and "what if's". My goal is to make this very confusing and not well explained law easy to understand for the typical staff member. I will uncover myths versus reality as it relates to this 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 also point out multiple court cases I have been affiliated with where a staff member of a hospital or clinic has been sued or even imprisoned! 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 should you Attend: Are you confused about HIPAA? Do you just want the basics and in plain English? Do you know there are civil and criminal penalties even for the rank and file staff member! Do you know what you can and can't do with protected health information? It is important to understand the new changes going on at Health and Human Services as it relates to enforcement of HIPAA for both covered entities and business associates as it relates to portable devices, texting, and emailing of PHI. You need to know how to avoid being low hanging fruit in terms of audit risk as well as being sued by individuals who have had their PHI wrongfully discloses due to bad IT practices. I have also been expert witness on multiple court cases where a business or medical practice is being sued for not doing their due diligence

Overview: Being in compliance with HIPAA involves not only ensuring you provide the appropriate patient rights and controls on your uses and disclosures of protected health information, but you also have the proper policies and procedures in place. If audited or the subject of a compliance review you will be required to show the government you have all the necessary documentation in place for safeguarding patient Protected Health Information and indicate how you addressed all required security safeguards. This starts with the fundamentals of a HIPAA compliance program. If your healthcare practice, business, or organization needs to understand how to put HIPAA compliance program in place or make sure the current program is adequate and can withstand government scrutiny, please join us for this informative and interactive course. Why should you Attend: With an increase in HIPAA enforcement and Phase 2 audits underway, many organizations need to fully understand the requirements of a compliance program. Attendees will leave the course clearly understanding of all the requirements for a comprehensive HIPAA compliance program and what steps need to taken to mitigate risk. After completing this course, a Covered Entity or Business Associate will have a clear roadmap for what needs to be place when it comes to all of the HIPAA regulations. Areas Covered in the Session: Why was HIPAA created? Who Must Comply with HIPAA Requirements? What are the HIPAA Security and Privacy Rules? What is a HIPAA Compliance Program? What is a HIPAA Risk Management Plan? What is meant by "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: Com

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

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

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

HIPAA Privacy Myths: HIPAA, the most comprehensive and as of now, the only truly Pan-American federal statute on health information, is unfortunately, still a target of misconceptions and myths. In particular, the Privacy Rule, which is the cornerstone of HIPAA's rule on confidentiality of patient information, offers room for many misconceptions. A few common HIPAA Privacy Myths: HIPAA Privacy Myths regarding communication between the patient and physician A common HIPAA Privacy Myth relates to the communication of mails between the patient and the physician. It is a common misconception that since the Privacy Rule is about ensuring the patient's privacy; it disallows email communication between the doctor and the patient. HIPAA Privacy Rule does allow this form of communication, so that the requisite safeguards are built into the communication aimed at ensuring the confidentiality and integrity of the mails. Transmission of the patient's protected health information Another of the common HIPAA Privacy Myths pertains to the transmission of patient information from one healthcare facility to another. Fact is, no permission is required for Covered Entities to disclose patient information from one clinic to another. The Covered Entity can also share Protected Health Information about the patient for legitimate purposes without the patient's consent or knowledge. Cumbersome and expensive HIPAA Privacy Rule regulations Many people tend to believe that the HIPAA Privacy Rule is a tangled web of regulations that are so complex and painstaking in terms of the administrative detail that implementation of the HIPAA Privacy Rule on a national scale is going to burn a hole in the national exchequer. This is completely untrue. On the contrary, over the years, implementation of the HIPAA Privacy Rule has been bringing down the administrative costs quite significantly, resulting in saving of a few billion dollars in the long run on administrative tasks like transactions

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

Overview: 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

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

Incidental disclosures form the crux of HIPAA compliance and patient care. HIPAA has elaborate rules on how to maintain these and in what situations. Health Insurance Portability and Accountability Act (HIPAA), a landmark set of federal regulations, is aimed at protecting patient privacy regulations. Yet, it is understood that some information has to necessarily be shared. HIPAA compliance and patient care is centered on the inevitable disclosures that have to be made, or what are called incidental disclosures. Initially, there was some ambiguity about incidental disclosures, resulting in some kind of haziness about HIPAA compliance and patient care. With these cleared, much of HIPAA compliance and patient care hinges on this principle. Incidental disclosures determine patient care compliance with HIPAA Incidental disclosures are what are termed secondary use, i.e., it is the unavoidable or inevitable disclosure of Protected Health Information. It is understood that incidental disclosures, being a byproduct of the course or nature of the treatment; are inescapable, given the condition and situation of the patient. Guiding factors for HIPAA compliance with patient care The aim of HIPAA's Privacy Rule is to ensure that healthcare providers have to use professional judgment guided by ethical guidelines at the time of making incidental disclosures. The following bases were propounded for adherence with HIPAA compliance and patient care: Whenever there is an unavoidable breach in confidentiality, the breach should be proportionate to the potential benefit the patient's gets from care When a patient is not present in the healthcare setting or is incapacitated, information about the patient can be shared with the family, friends or whoever else is involved in the patient's care. This protocol need not be documented. In relation to the above, a requirement of HIPAA compliance for patient care is that when the patient has a condition that is not related to the present tr

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: 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: 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

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

Standard Operating Procedures for Clinical Trials: A set of standard operating procedures for clinical trials is absolutely vital for ensuring the effectiveness of the study for a number of reasons. Standard operating procedures for clinical trials are a very potent means to help researchers, principals or sponsors ensure the accuracy and consistency of the procedures needed for the clinical trial. What are standard operating procedures for clinical trials? Standard operating procedures for clinical trials are written instructions that are detailed to provide information about every aspect of the trial. With this set of standard operating procedures for clinical trials, principals seek to bring about a level of uniformity in a particular task of the clinical trial. Consistency in these standard operating procedures for clinical trials has to be ensured so that the clinical trial meets local, state and federal government and global guidelines and requirements. Equally importantly, standard operating procedures for clinical trials have to also meet regulatory guidelines set out by bodies such as the FDA. The purpose of standard operating procedures for clinical trials should be to help the trial achieve consistency in the quality control and quality assurance. In addition, standard operating procedures for clinical trials should be designed to help the trial achieve the quality of auditability. This is because any clinical trial goes through audits from regulatory bodies, making the role of standard operating procedures for clinical trials all the more important. Factors to bear in mind while establishing standard operating procedures for clinical trials: Standard operating procedures for clinical trials should thoroughly document these among other elements: Event Reporting Safety Monitoring Laboratory Management Pharmacy Management Development of Protocols Informed Consent Operations at the site of the clinical trial While these may be considered the core asp