Overview: The HIPAA Rules and HHS/OCR guidance provide a simple, easy to use 3 Step Safe Harbor for using unencrypted email and text messaging to engage patients. This session will explain the 3 Step HIPAA Safe Harbor. The secret is - HIPAA Rules are easy to follow, step-by-step - when you know the steps.
Why should you Attend: Patient Engagement is a cornerstone of effective patient care. Communication technology offers indispensable patient engagement tools. Secure patient portals are available. So are encrypted text message and email products. But patients overwhelmingly choose non-secure communication tools like text messaging and email.
Appointment reminders, healthcare instructions, patient satisfaction surveys, health and wellness newsletters and recall reminders are just a few patient engagement tools sent electronically by regular (unencrypted) email and text messaging.
Overview: In this session Mr. Wolfe will provide an overview of the Stark Law, including its recent changes. He will also discuss best practices for negotiating and drafting administrative arrangements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided.
Why should you Attend: As health care organizations and physicians develop administrative arrangements, they must manage their compliance and enterprise risk by ensuring any new arrangements are defensible under the Stark Law. Prior to moving forward with any arrangement, the parties should carefully evaluate whether the proposed structure and financial terms support compliance with Stark's technical requirements and key tenets of defensibility so they will be prepared to mount a defense in the event the arrangement is ever challenged.
Overview: Everyone in the healthcare industry knows about HIPAA (the Health Insurance Portability and Accountability Act), that has been in effect since 1996. The goal of the legislation was fairly simple - to safeguard our patient health information.
The law dictated to entities how to protect health information (PHI), how it can be shared, when it can be shared, and with whom it can be shared.
To date, even the best of healthcare organizations struggle with feeling confident that they have all the required areas covered to protect and prevent HIPAA violations from occurring in their organization. It is well documented that by initiating proper training and implementing effective monitoring tools, HIPAA violations can be reduced or more readily identified in the workplace. Often there is not clear communication to employees about "what constitutes a HIPAA breach" and how can this be reported in your organization without "fear of retaliation."
Overview: Humans are thinking machines and most people have similar thought processes. Most people have reasonable, measured, moderate thoughts. And while there are many variations on this theme, these thoughts occur on a bell curve with most people being in the meaty part of the curve.
Those with major depressive disorder (major depression), however, often have very extreme thoughts and their thought processes often exist on the very far ends of the bell curve. This can make understanding how a person with major depression acts very challenging as these actions are driven by thought processes the average person doesn't experience. While these thoughts may seem “crazy” at first, it's important to realize that these thoughts are simply an extreme part of the human experience that do fall along a continuum that is experienced by everyone.
Overview: In this session Mr. Wolfe will provide an overview of the Stark Law and Anti-Kickback Statute. He will also discuss best practices for structuring, negotiating physician employment agreements. The webinar will focus on regulatory requirements,key provisions, valuation considerations and potential pitfalls that should be avoided.
Why should you Attend: As health care organizations and physicians develop their employment arrangements, they must ensure the employment and compensation structures are defensible under the Stark Law and Anti-Kickback Statute.
In this webinar Mr. Wolfe will describe how to develop employment structures and financial terms that comply with the technical regulatory requirements and key tenets of defensibility (fair market value, commercial reasonableness, etc.) to manage risk.
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 practice acquisition arrangements on behalf of health systems, hospitals, medical groups and physician practices. The webinar will focus on regulatory requirements, key provisions, valuation considerations and potential pitfalls that should be avoided.
Why should you Attend: As health care organizations and physician practices pursue acquisition strategies and transition to more innovative post-transaction models, they must manage their compliance and enterprise risk by ensuring any new arrangements are defensible under the Stark Law.
This lesson will be addressing how practice/business managers (or compliance offers) need to get their HIPAA house in order as HIPAA is now fully enforced and the government is not using kid gloves any more.
This presentation, will aid manufacturers of medical devices who intend to modify a 510(k)-cleared device or a preamendments device subject to 510(k) (i.e., "existing devices") during the process of deciding whether the modification exceeds the regulatory threshold of 21 CFR 807.81(a)(3) for submission and clearance of a new 510(k).
Validation is an important element of the Quality System Regulations and ISO13485. This course will cover the requirements the essentials of validation. You'll learn about what processes needed to be validated and what steps you need to take to validate processes. You'll learn the essentials of validation planning, protocol writing, and change management
We'll cover the steps of Installation Qualification (IQ),Operational Qualification (OQ), and Performance Qualification (PQ) including tips and best practices.
This course aims to provide basic training for those concerned with pharmacovigilance, This course has been planned to provide you with the essential skills and tools to prepare and host a regulatory inspection and to facilitate the response and follow-up to the inspection outcome, findings (483s) and the necessary Corrective Actions and Preventive Actions (CAPA).
How to choose/make standards:
Lab-based standards are most often synthetic, with final forms tested for extraction of all the analyte Process samples are most often final product, scanned spectroscopically, then analyzed via a referee method. Process stds may be made synthetically, but several precautions need to be taken.
On 4 May 2016, the official texts of the Regulation and the Directive have been published in the EU Official Journal in all the official languages. While the Regulation will enter into force on 24 May 2016, it shall apply from 25 May 2018. The Directive enters into force on 5 May 2016 and EU Member States have to transpose it into their national law by 6 May 2018.
The verification and validation of regulated software is coming under increased scruinty by the U.S. FDA.This webinar will address the use of the FDA, GAMP, 21 CFR Part 11,"Electronic Records"/"Electronic Signatures", IEC 62304, and other applicable industry software validation models, coupled with the ISO 14971/ICH Q9 Product Risk Management models, to plan, structure, run, and document acceptable software validations.
This webinar will give you the tools that you need to ensure that you understand data integrity issues and best practices for ensuring data integrity at your company.
Why should you Attend: The FDA is increasingly focusing on data integrity issues, including data manipulation, when conducting facility inspections. Concerns over data integrity issues have resulted in the agency adding companies to the for-cause inspection list, and the FDA has found questionable data during in a significant number of these for-cause inspections. The FDA is noticing some electronic data manipulation in parts of its inspection program and is focusing on training its investigators to be more alert to data manipulation, Branding said.
The subject of this webinar is building the project team, The key to achieving success with your project is the people you assign to it, how well you develop the team, and sustaining team member's ongoing commitment to the successful completion of the project, Also you will learn This process includes developing team and individual team member goals, determining the team's operating processes, and building strong team member relationships.
This course will provide insights into current knowledge of human error and how it can be reduced, The course will provide hands-on experience of practical error reduction techniques, using real-life case studies, You will also gain an understanding of the underlying causes of human error and how to reduce its occurrence by changing the culture of the organization and changing the design of the processes.
This session will address the specific way of documenting your computer system validation work to ensure it meets FDA requirements and can pass an inspection, also this webinar will help you understand the FDA's requirements for good documentation, including how to handle change control and the importance of audit trails, you will learn how to create and maintain good documentation that meets FDA compliance standards.
The United Kingdom submitted its' notification on 29 March 2017 to withdraw from the European Union. This means that unless a withdrawal agreement establishes another date, all EU primary and secondary Laws cease to apply to the UK from 30 March 2019 going forward.
The UK, by definition would become a "third country". Preparing for the withdrawal doesn't just involve the Healthcare Authorities, but every manufacturer and /or license holder of a pharmaceutical, biologic, medical device or combination product in the UK and EU.
In this webinar, change control procedures within quality management systems (QMS) for documentation and information technology systems will be discussed, And you will learn about change control process and change control procedures as they apply to documentation and information technology systems in regulated industries.
A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed device (21 CFR 807.92(a)(3)) that is not subject to PMA. The FD&C Act and the 510(k) regulation (21 CFR 807) do not specify who must submit a 510(k). Instead, they specify which actions, such as introducing a device to the U.S. market, require a 510(k) submission. You will learn about Substantial Equivalence to support a 510(k) submission.