Healthcare Laws/Reform

Overview: Some of these new mobile apps / software functions are specifically targeted to assisting individuals in their own health and wellness management. Others are targeted to health care providers as tools to improve and facilitate the delivery of patient care. These software devices include products that feature one or more software components, parts, or accessories, as well as devices that are composed solely of software. Certain software functions / mobile apps that are device functions can pose potential risks to public health, and these are the subject of FDA concern and focused regulation. Mobile medical apps, as defined here, include only those mobile apps that: Meet the definition of a device Intended to be used as an accessory to a regulated medical device Intended to transform a mobile platform into a regulated medical device. What are they as defined by the FDA, what are not? Requirements? Cybersecurity, documentation and validation requirements

Overview: This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.

Overview: Standard Operating Procedures (SOPs) are a regulatory requirement for industries that are governed by the FDA and other world health authorities. Currently, there is no guidance on how to develop or manage the SOP creation or the SOP quality system. Why you should Attend: Consequently, SOPs are frequently written in a way that makes compliance difficult or downright impossible. In many cases, this sometimes leads to subpar documents that come to light during a regulatory inspection. In this webinar you will learn how to write, organize, and maintain SOPs and train personnel in a way that will ensure compliance in a way that is reproducible and easy to follow.

Overview: As a "GxP" system, following Good Manufacturing, Laboratory and Clinical Practices, the computer system must be validated in accordance with FDA requirements. If electronic records and/or electronic signatures (ER/ES) are incorporated into the system, FDA's CFR Part 11 guidance on ER/ES must be followed. This webinar will focus on the key areas that are most important, including security and data integrity. Implementing and following the System Development Life Cycle (SDLC) methodology is the best approach for computer system validation and maintaining data integrity.

Overview Most Regulatory Agencies require firms to have written procedures in place to document production and process controls, better known as batch records. Additionally, there must be written procedures for a batch record review process that demonstrate compliance. A strong batch record review system is essential in order to properly document all critical processing parameters that go along with the production and manufacture of pharmaceuticals, biologics, medical devices, etc. This webinar will analyze each of these necessary elements of the batch record review process.

This course covers the fundamentals of medical billing, coding, and reimbursement by explaining how all of these components work together. Emphasis will be placed on the practical application of the latest industry knowledge and standards, with the goal of helping those who work with medical claims and claims data stay ahead of the game. Participants will learn about the following: The claim flow process from registration through adjudication and payment How physicians and hospitals set and manage charges Critical data elements on the two major claim forms and what they mean How and why the major coding systems are utilized How various reimbursement methods are used by payors

The main document from a regulatory perspective in the development of a medicinal product is the regulatory plan. In this Seminar it is explained how to write the regulatory plan, and which aspects to consider. The regulatory plan describes the regulatory strategy, as well as pricing and reimbursement issues in your development. Orphan Medicinal Products will be discussed, and the advantages of having a status as an orphan medicinal product will be explained. Incentives for the development of orphan medicinal products have been available in the United States of America since 1983 and in Japan since 1993, and also the EU offers a range of incentives to encourage the development of these medicines.

Overview: 21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record. This webinar will discuss basic Dietary Supplement CGMP of Part 111 and related requirements, to include: Quality Management System / QA / QC Personnel, Facilities, Equipment Software controls Production and Process Controls Holding and Distribution Complaints and Returns Records

Overview: This webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order before the imminent audits occur with strong bipartisan backing in Washington. It will also address major changes under the Omnibus Rule and any other applicable updates for 2021. We will also delve into some of the changes relating to telemedicine and COVID19.

Overview: In this session Mr. Wolfe will provide an overview of the Anti-Kickback and Stark Laws and their fair market value and commercial requirements. He will distinguish between what is legally required, what is a developing best practice and finally, will discuss common misunderstandings and misconceptions related to fair market value and commercial reasonableness in the industry.

Overview: It seems everyone is moving to a new smart phone and wants to use it in all the incredible ways it can be used, including for health care purposes. New health care apps are being released all the time, and even good old e-mail is being used more and more to communicate, by providers and patients alike. In order to integrate the use of mobile technology into patient communications, it is essential to perform the proper steps in an information security compliance process to evaluate and address the risks of using the technology. This session will describe the information security compliance process, how it works, and how it can help you decide how to integrate mobile technology into your organization in a compliant way. The process, including the use of information security risk analysis, will be explained, and the policies needed to support the process will be described

Overview: This 90-minute webinar will be going into great detail regarding you practice or business information technology and how it relates to the HIPAA/HITECH Security Rule and securing PHI in transmission. I will go through multiple examples and specific scenarios and also offer simple common-sense solutions. Areas covered will be texting, email, encryption, medical messaging, voice data, personal devices, and risk factors.

Overview: This session will focus on the rights of individuals to communicate in the manner they desire, and how a medical office can decide what is an acceptable process for communications with individuals.

Overview: This EU Medical Device Regulation (MDR) 90-minute webinar will discuss the recently developed regulation and its impact on the future compliance and registration of medical devices in the EU. It includes specific insights from direct involvement and work within the EU and the Commission's major improvement objectives to their system today. Areas of change between the prior Medical Device Directive (MDD) and the MDR will be discussed as well as expectations for how to implement ISO-13485:2016.

Overview: It is important that the sterile filtration process is fully understood and properly validated for your particular application. The process requirements and validation needs differ based on the filtration requirement. This webinar will give you a comprehensive understanding of this important subject with an emphasis on the different types of sterilizing filtration available and their application to your particular system. For example, the application of sterile filtration to use-point compressed air is discussed in detail.

Overview: Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences. When working with these challenges, it is imperative to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and fixed.

Overview: This 90-minute webinar will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA HITECH is now fully enforced with bipartisan support and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule, Trump (or Biden) administration, new congressional mandates and any other applicable updates for 2021 and beyond along with changes relating to COVID19 and Information Blocking under the Cures Act (do’s and don’ts). There are an enormous amount of issues and risks for covered entities and business associates these days - we will speak to the most common violations and fines - and how to best avoid fines and headaches.

Overview: In this session Mr. Wolfe will provide practical guidance on contracting with physicians for telehealth services, including the regulatory requirements, key provisions and emerging compensation models.

Early clinical trials are conducted to establish initial safety of a drug.The studies are generally in small number of healthy subjects and use lower doses of the drug product. Therefore, only small amounts of investigational material are required. In order to not undertake substantial costs and to reduce regulatory burden during these early stages, the FDA has established guidelines to allow early stage investigational products to be manufactured under less stringent GMPs.

Overview: This webinar describes exactly what is required for compliance with Part 11 and the European equivalent Annex 11 for local, SaaS/Cloud hosted applications. It explains how to write a Data Privacy Statement for compliance with EU General Data Protection Regulation (GDPR). What the regulations mean is described for all four primary compliance areas: SOPs, software features, infrastructure qualification, and validation. It gets you on the right track for using electronic records and signatures to greatly increase productivity and ensure compliance.