Overland Optical, you will never be treated like just another appointment. Our experienced doctors and responsive staff members will make sure you always feel welcome and well cared-for during your visit.
Overland Optical Family Eye Care and/or our doctors are providers on virtually all medical and vision insurance plans. We want to help you receive the most out of your insurance benefits, which is why we will gladly file your insurance claim for you if we have been provided with all of your insurance information.
Don't miss out on this great promotion! Enjoy up to 30% off every eyeglasses & Eyewear product in St. Louis, IL area. See office for details. This offer ends March 31, 2015. For more details call us 314-423-3874 & Email: ovstaff@overlandoptical.com
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:
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
Overview:
The trial master file is a hard copy of all documentation relating to a clinical trial. It contains essential documents. When studies are conducted under ICH E6 Good Clinical Practices (GCP), this collection of documents must be present before, during and after the trial. These documents help provide quality assurance and help researchers evaluate their compliance with GCP, federal regulations and applicable laws.
Why should you Attend: Anyone responsible for handling trial documentation or quality assurance activities.
Areas Covered in the Session:
Trial Master File (TMF): what is it?
Essential documents required
ICH guidelines and Good Clinical Practice (GCP)
Food and Drug Administration (FDA) guidance and expectations
Paper or electronic trial master files - what is allowable
Links to useful resources
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
Human Subjects Research
Healthcare interested in exploring the field of Clinical Research
New Clinical Research Coordinator positions (1-2 years)
New Principal Investigator positions
Administration in charge of Clinical Research
Regulatory Compliance
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 state and federal authorities.
She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fundamentals of research manageme
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 inspectional non compliance.
The right choice of electronic data capture, direct data entry, and data management depends on a sponsor assessment of the systems and procedures at the investigator site as compliant with FDA inspectional requirements. Additional source documentation procedures (origination, authorization, and signature) are required at the investigator site to address the electronic data capture process. It is these three FDA mandated inspectional criteria, applicable to every electronic data element, that generate most of the significant inspectional noncompliant findings. Some data elements are more likely to be associated with the findings of noncompliance than others. It is in fact difficult to determine which data requires or does not require original source documentation and what defines "original source documentation".
Why should you attend: Investigators commonly assume that the new guidance and regulations reduce the need for source documentation in clinical trials. In fact, there are new procedural documents relevant to the electronic source documents and direct data entry that are required to comply with the current inspectional standards and the final guidance. Sponsor due diligence in choosing, training, and monitoring investigator sites to enable the use of compliant electronic data capture is required.
Basic knowledge of part 11 and GCP requirements will be helpful in attending this advanced webinar. The focus will be on the additional FDA inspectional requirements for electronic data capture, and the impact of using electronic data capture on the seven FDA inspectional priority objectives
Be sure they specialize in eyeglass repair of your specific type of glasses. With the various brands & types of glasses, be sure yours are in gook, capable hands. You can trust the professionals at Overland Optical. We are a leading medical eye care provider, offering a high level of experience & expertise to families in the St. Louis, Missouri.
Overland Optical Family Eyecare team is made up of some of the most caring individuals & experienced medical professionals. Everyone in both of our offices works closely together to deliver the best possible patient experience.
Overland Optical Family Eyecare, you will never be treated like just another appointment. Our experienced doctors and responsive staff members will make sure you always feel welcome and well cared-for during your visit.
Overview: The Sunshine Act, or Open Payments Program, requires manufacturers of drugs, medical devices, and biologics that participate in U.S. federal health care programs to report certain payments and items of value given to physicians and teaching hospitals. This Act was part of a healthcare reform bill adopted in March 2010. It came about due to requests for increased transparency about the financial relationships between physicians and industry.
The Centers for Medicare and Medicaid (CMS) issued the final rules in 2013 which implemented the Sunshine Act.
Why should you Attend: Anyone required to adhere to the Sunshine Act standards or anyone interested in knowing what must be reported and made public.
Areas Covered in the Session:
Purpose of the Sunshine Act
Who is required to report under the Sunshine Act?
What is reported?
Exclusions
Tracking
Penalties
Useful links
Who Will Benefit:
This webinar will provide valuable assistance to all personnel in:
Human Subjects Research
Healthcare interested in exploring the field of Clinical Research
Clinical Research Coordinators
Principal Investigators/Physicians
Administration in charge of Clinical Research
Regulatory Compliance
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 state and federal authorities.
She has provided consultation regarding ethical, federal, state, and institutional requirements for faculty and staff both in the design and execution of their projects and teaches research ethics and regulatory affairs and the fu
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
Overland Optical provides exceptional eye care and superior eyewear for whole family. We are a leading medical eye care provider in the area and the preferred source for quality vision care for families.
Overland Optical provides exceptional eye care and superior eyewear for whole family. We are a leading medical eye care provider in the area and the preferred source for quality vision care for families.
Eye exams are important for patients of all ages to get regular eye exams whether they are having problems or not. Eye exams can detect a problem before you even know you have one. This is particularly important if you have a family history of eye problems.
Whether you wear glasses as a backup when your eyes need a break from your contacts or they're your go-to vision aid, you know that between the frames and the lenses, eyeglasses are an investment.