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Rationale for Clinical Trial Regulations Clinical trials, as we all know, are carried out to test the efficacy of a new drug or device being developed for a specific condition or disease. Clinical trials are experiments that have a high degree of risk if they are not properly implemented. For this reason, it is necessary for regulatory bodies to regulate clinical trials. The core rationale for regulating the various stages of clinical trials is that human subjects, who are part of the research, have to be protected. These clinical trial regulations are legislated at all stages: local, State, national and international. Clinical trial regulations are in force in different countries of the world. Common clinical trial regulations are also made globally by the International Conference on Harmonization (ICH), which has the mandate of setting out good practices for clinical trial regulations for trials done in global cooperation. These regulations cover the administrative, procedural and ethical aspects of clinical trials. Briefly, these are the areas in which there are clinical trial regulations for each of these aspects of clinical trials: Administrative: The administrative aspects of clinical trial regulations pertain to the way the clinical trials are run, and the way they are tracked and monitored throughout their lifecycle. A clinical trial is usually monitored by a sponsoring company or a Contract Research Organization (CRO), which the former hires at times for reasons of convenience and cost cutting. Clinical trial regulations in this area is obviously of importance because if something goes wrong at any administrative stage; these can be rectified. Procedural: Procedural aspects of clinical trial regulations relate to ways by which subjects are chosen for a clinical trial. Proper care has to be taken to ensure that the subjects are appropriate for the clinical study, are from the prescribed age, geographical, demographic, racial and gender-related cl

Workplace Safety Regulations : Workplace safety is a matter of grave importance to any organization. Ensuring the safety of workers is a primary goal of most countries, no matter which kind of political system or setup they have. This is because almost no workplace is free from some or another kind of hazard. These workplaces could be as varied as hospitals, construction sites, engineering plants or agriculture and many more. Governments the world over consider it their duty to provide a safe workplace. Workplace safety can concern any hazard that can happen to either the physical or emotional wellbeing of a worker. National and global workplace safety regulations : Workplace safety regulations are legally stipulated measures that governments require organizations in both the private and public sector to implement in order to ensure safety at the workplace. Almost all countries have their own set of workplace safety regulations. These regulations work in tandem with a few global management systems with the aim of enhancing safety standards at the workplace. A notable global organization that is at the forefront of legislating workplace safety regulations is the International Labor Organization (ILO). These ILO-mandated legislations are meant to supplement the national workplace safety regulations that most countries have. This is done in the belief that many a time, these individual legislations may not be sufficient in themselves. Workplace safety regulations in the US : Like most other countries, the US too has its own set of Occupational Safety and Health (OSH) standards. Owing their origins to the Richard Nixon era in late 1970; workplace safety regulations in the US concretized under what is collectively called the Occupational Safety and Health Administration (OSHA). The major feature of OSHA is that apart from promulgating workplace safety regulations across nearly all conceivable sectors and types of industries; OSHA also has a provision for whistleblow

Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program

Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program

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

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

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

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

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

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

Implementation of Regulatory Aspects of Clinical Research is critical One of the prime areas of clinical studies is regulatory aspects of clinical research. This applies in almost equal measure to medical research as a whole. The FDA and other regulatory bodies have spelt out a number of regulations that have to be complied with if the clinical research is to be approved. These regulatory requirements cover all aspects of clinical research. A look at some of these regulatory aspects would be instructive: FDA requirements on regulatory aspects of clinical research The FDA has an exhaustive list of regulations relating to Good Clinical Practice (GCP), the area which forms the backbone of regulatory aspects of clinical research. The FDA has a series of regulations that are aimed at bringing in discipline and process into clinical research. It implements all the laws relating to GCP passed by the American Congress. At present, there are a huge number of regulatory standards and requirements that have to be complied with by those undertaking clinical research in the US. These regulations are codified in the 21 CFR series. Notable sections of the 21 CFR series relating to regulatory aspects of clinical research include: 21 CFR Part 11 21 CFR Part 16 21 CFR Part 50 21 CFR Parts 50 and 56 21 CFR Part 54 21 CFR Part 58 21 CFR Part 312 21 CFR 312.120 21 CFR Part 314 21 CFR Part 320 21 CFR Part 511 21 CFR Part 514 21 CFR Part 601 21 CFR Part 812 21 CFR Part 814 EU requirements on regulatory aspects of clinical research In the EU, the core aspect of regulatory aspects of clinical research relates to the primary importance given to the subjects in a clinical research. For example, regulatory aspects of clinical research France are guided by the Public Health Code and Civil Code. This Code contains a list of regulatory conditions clinicians are obliged to adhere to. These regulations are to be monitored by a number of regulation enforcement bodies that the French governm

Overview: Today's educated professionals function in a maze of different educational and training requirements, which vary from state to state and from profession to profession. Nowhere than in health care is this more evident where multidisciplinary health care practitioners work together towards a common goal for the patient. What is a profession? What areas of work require the unique professional education, training, and experience that becomes mandated by the state? What work requires professional judgment and skill so as to be regulated by the government through mandatory laws applicable to an individual person practicing his or her chosen profession? State laws are enacted for the protection of the public by legislatures in all the fifty states. A list of individual professions and their applicable statues and administrative regulations takes up entire volumes of lawbooks. These state laws impose significant regulation on these professionals, and often in very different ways found in many aspects of state regulation, from the educational process, the examination requirements, the state licensure applications, and the legal standards and rules of each unique profession. Explore how state licensure boards are created and function at the state level. While most such state agencies have common, core functions and operations, there are many differences - and some requirements that are truly the opposite from profession to profession. Review the common requirements the state imposes on the health care provider. Know the basics of professional education and licensure. Understand the difference between legally binding laws and mere codes of ethics, which are aspirational and do not form the basis for legal action. Find out how to understand and navigate the challenges presented from differing and conflicting state laws governing the many health care professions. Know where key requirements exist that are common to many professions. This program offers an obje

Course "Supplier Management for Medical Device Manufacturers" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Supplier selection and management is one of the critical issues for medical device manufacturers. Suppliers provide materials and services to the device manufacturer, which means that they can be critical to performance and delivery of your device. Neither the FDA nor your notified body regulates your suppliers (with a few exceptions). They expect you to have an effective process to ensure your suppliers perform in the regulatory environment. How well do you understand the requirements for supplier management? Could you pass a regulatory audit or inspection without any issues? This course delivers the tools, templates, and methods to help participants implement an effective and efficient supplier management program. This two-day hands-on course provides a clear understanding of the underlying principles of supplier management. The course uses exercises to solidify understanding. In addition, the course uses FDA Warning Letters to illustrate the points and help you learn from others. As part of the practical implementation, the course includes receiving acceptance activities, outsourced processes, process validation at the suppliers' location, supplier auditing techniques, and supplier issues in management review. The course uses the Global Harmonization Task Force (GHTF) framework, but expands it to cover other issues and techniques important in effective implementation. Why should you attend: Since FDA regulations do not allow them to audit your suppliers unless they make finished medical devices, they require that you have sufficient control over them. But from time to time the FDA makes a reinterpretation of what this means. This happened within the last f 5 years, so if you supplier management program is older than that, you need to make major changes in you supp

Course "Key Factors to Write an Effective Standard Operating Procedure (SOP) and Work Instructions (WIs)" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion. Overview: Writing SOPs or procedural documents can be challenging at times. However, writing SOPs is overall a straightforward process. However, enforcing what you already created and implemented in the pipeline is another story. The term SOP is very obvious. We have seen "clearly written description of how specific tasks are to be done." Another satisfactory definition would be "detailed written instructions that achieve the uniformity of the performance of a specific function." Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? If you are medical device or a pharmaceutical manufacturer, these definitions come as no surprise because when it comes to FDA regulations and guidance documents "establish" means to define, to document (in writing or electronically) and to implement. The goal and emphasis with FDA is simple. Proof of "Establish" is the foundation. Is the firm doing what the regulations specify? Is the firm doing what their procedures specify? Are the procedures being followed and enforced by company personnel? SOPs are needed in regulated industries to give step-by-step instructions for performing a particular job or task. This session will provide a step-by-step overview and a snapshot of the procedure description, the process and format. The subject matter of a SOP may range from how to operate a piece of machinery to how to log into a particular software program. SOPs ensure consistency and reliability because they require training of all affected parties. This session will address recent enforcement actions for SOP related violations but no surprise. Most of our enforcement actions are documentation related, i.e., SOP or other procedural documents. We will review examples from

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: Today's health care delivery occurs in a diverse, fast-changing, multidisciplinary health care environment. This often presents challenges to the health care professional that are not easy to navigate. Medical records and their confidentiality have long been the exclusive province of state law, but has now been recognized for some time in the federal HIPAA statutes and federal regulations. Differing and even conflicting sources of requirements at the state level still exist for the retention and disposition of medical records. These sources may vary based upon the specific health care practitioner - whether physicians, dentists, psychologists, or other health care providers, including mental health practitioners. As to the specific, individual health care practitioner, state laws mandate their confidentiality, retention, and even their specific content with regards to patient, clinical records. In addition to these clinical requirements, additional state laws set forth the content and retention of other types of records kept by the professional, such as supervisory agreements with other professionals subordinate to them as well as their own unique record content requirements. With the majority of medical records moving to an electronic format, special rules now exist with regard to the confidentiality, security, retention, and disposition of electronic medical records. This is particularly important as state laws continue to allow for and regulate the provision of telemedicine by various health care practitioners. For example, while psychotherapy and mental health services are ideal treatments to offer over the internet, that is, by simultaneous audio-visual transmission between the doctor and the patient, the risks of breaches of confidentiality also vastly increase. And when the successful doctor-patient relationship is over, how does the health care practitioner providing a mental health service dispose of these electronic records? In addit

Overview: Today's health care delivery occurs in a diverse, fast-changing, multidisciplinary health care environment. This often presents challenges to the health care professional that are not easy to navigate. Medical records and their confidentiality have long been the exclusive province of state law, but has now been recognized for some time in the federal HIPAA statutes and federal regulations. Differing and even conflicting sources of requirements at the state level still exist for the retention and disposition of medical records. These sources may vary based upon the specific health care practitioner - whether physicians, dentists, psychologists, or other health care providers, including mental health practitioners. As to the specific, individual health care practitioner, state laws mandate their confidentiality, retention, and even their specific content with regards to patient, clinical records. In addition to these clinical requirements, additional state laws set forth the content and retention of other types of records kept by the professional, such as supervisory agreements with other professionals subordinate to them as well as their own unique record content requirements. With the majority of medical records moving to an electronic format, special rules now exist with regard to the confidentiality, security, retention, and disposition of electronic medical records. This is particularly important as state laws continue to allow for and regulate the provision of telemedicine by various health care practitioners. For example, while psychotherapy and mental health services are ideal treatments to offer over the internet, that is, by simultaneous audio-visual transmission between the doctor and the patient, the risks of breaches of confidentiality also vastly increase. And when the successful doctor-patient relationship is over, how does the health care practitioner providing a mental health service dispose of these electronic records? In addition to

Overview: One of the major requirements of the health care organization to be HIPAA compliant is to develop and implement a set of HIPAA privacy and security policies and procedures. This can be a daunting task for those not knowing where to start and what a set of HIPAA privacy and security policies and procedures should look like. For the cost conscious health care organization, the HIPAA policies and procedures can have multiple uses: first, they can become a basis for training the health care organization workforce; second, they can be used as a basis for conducting a HIPAA self-assessment; and third, they can be used to demonstrate due diligence should there be a breach or an externalHIPAA compliance audit. In today's world it is not necessary that the health care organization spend significant funds to develop a set of HIPAA privacy and security policies and procedures from scratch. The health care organization can likely find templates on the internet that can be used as a starting point to customize HIPAA policies and procedures to be unique for the health care organization. The preparation of a well-documented set of HIPAA policies and procedures needs to be addressed through the development of Privacy and Security policies and procedures that address each of the requirements shown in the HIPAA regulations as amended by the HITECH law and the final Omnibus Regulations. The process of developing the HIPAA privacy and security policies and procedures also provides a reference for the health care organization how to consider the security addressable and required regulation requirements. Why should you attend: There are three situations where having a set of HIPAA policies and procedures are needed: First, the policies and procedures become a good reference to ensure that all areas are addressed for becoming HIPAA compliant. Second, the HIPAA regulations REQUIRE covered entities and business associates to have a set of policies and procedures directing

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

Overview: One of the major requirements of the health care organization to be HIPAA compliant is to develop and implement a set of HIPAA privacy and security policies and procedures. This can be a daunting task for those not knowing where to start and what a set of HIPAA privacy and security policies and procedures should look like. For the cost conscious health care organization, the HIPAA policies and procedures can have multiple uses: first, they can become a basis for training the health care organization workforce; second, they can be used as a basis for conducting a HIPAA self-assessment; and third, they can be used to demonstrate due diligence should there be a breach or an externalHIPAA compliance audit. In today's world it is not necessary that the health care organization spend significant funds to develop a set of HIPAA privacy and security policies and procedures from scratch. The health care organization can likely find templates on the internet that can be used as a starting point to customize HIPAA policies and procedures to be unique for the health care organization. The preparation of a well-documented set of HIPAA policies and procedures needs to be addressed through the development of Privacy and Security policies and procedures that address each of the requirements shown in the HIPAA regulations as amended by the HITECH law and the final Omnibus Regulations. The process of developing the HIPAA privacy and security policies and procedures also provides a reference for the health care organization how to consider the security addressable and required regulation requirements. Why should you attend: There are three situations where having a set of HIPAA policies and procedures are needed: First, the policies and procedures become a good reference to ensure that all areas are addressed for becoming HIPAA compliant. Second, the HIPAA regulations REQUIRE covered entities and business associates to have a set of policies and procedures directing t

Overview: Drug and device research is confusing and difficult on its own but when you start combining drugs with devices the regulatory landscape changes as there are more nuances to deal with. Knowing how drug and device studies are each regulated is important in navigating the challenges posed by studies that wish to use both. It is also important to be aware of current guidance affecting the use of both drugs and devices in a study as well current guidance affecting the classification of devices. Why should you attend: Information on drugs and devices is plentiful. But, it can also be daunting .The webinar will give attendees a foundation and a starting point on which they can build. Learning objectives: Define drug research Define device research Explore the differences between the two Describe requirements when drugs and devices are combined in one study Areas Covered in the Session: Defining Drug Research FDA approved drugs Investigational drugs Compassionate use Defining Device Research FDA approved devices 510 K devices Humanitarian Device Exemptions Invitro Diagnostic Devices Investigational Devices Federal regulations governing drugs and devices Guidance governing drugs and devices Combining devices and drugs into one study What are the requirements? What are the regulations and guidance? How these studies are reviewed Who Will Benefit: Investigators Researchers Research Staff Study Coordinators Auditors Research Administrators 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 st