Training Options Duration: 60 Minutes Monday, December 4, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: The presentation takes the participant through the steps needed to ensure a successful health care computer system implementation. Once presented the participant will see the logic of the tools and processes and be able to apply them to their system implementation. The tools and processes presented in this material have been developed by impl...

Training Options Duration: 60 Minutes Monday, December 4, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: FDA 7348.811 section 1 states, "Regardless of the type of system used by the clinical site, the regulatory requirements for clinical data do not change whether clinical data are captured on paper, electronically, or using a hybrid system." What type of system is best for your program and investigator capabilities? The wrong choice yields insp...

Training Options Duration: 60 Minutes Monday, December 4, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: In this session Mr. Wolfe will provide an overview of the Stark Law, including its 2016 changes. He will also discuss best practices for negotiating and drafting physician employment agreements on behalf of health systems, hospitals and medical groups. He will explain key provisions and potential pitfalls in both types of agreements. Why shou...

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 faci...

This lesson will be addressing how law firms who work with protected health information need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more. It will also address major changes under the Omnibus Rule and any other applicable updates for 2017 and beyond. There are an enormous amount of issues and risks for covered entities and business associates these days as it relates to pa...

Training Options Duration: 60 Minutes Tuesday, November 28, 2017 | 10:00 AM PDT | 01:00 PM EDT 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...

Training Options Duration: 90 Minutes Wednesday, November 22, 2017 | 10:00 AM PDT | 01:00 PM EDT 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...

Training Options Duration: 60 Minutes Friday, November 17, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: The Federalwide Assurance is required for NIH funded studies. It is a written assurance filed with the Office for Human Research Protections (OHRP) that outlines under which terms a study will be reviewed, approved, and conducted. This document, signed by the Institutional Official, sets forth certain requirements that must be upheld by an i...

Training Options Duration: 90 Minutes Wednesday, November 15, 2017 | 10:00 AM PDT | 01:00 PM EDT Overview: Whenever workers enter an area where there is a possibility of exposure to hazardous or toxic substances, or where there is a possibility of injury or harm due to entering a space with only one way in and out, and where only a single employee may work, OSHA has provided written regulations requiring that the space be designated as a hazar...

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...