21 CFR Part 11 Compliance - Ensuring Data Integrity and Safety in Clinical Research Electronic medical records and electronic handling of study data is increasingly common. To involve computer systems in clinical research implies knowledge of 21 CFR Part 11 (ELECTRONIC RECORDS; ELECTRONIC SIGNATURES) and all of the ramifications of this Part of the code is essential. Live
Wednesday,
June 19, 2013
10:00 AM PDT | 01:00 PM EDT,
Duration:90 Minutes
What is a Serious Adverse Events and how do I handle these? When conducting clinical trials it is important to understand and be able to identify serious adverse events (SAE). These are events that are serious, likely related to the study drug, device, treatment or procedure, and increase risks to participants or others. Live
Thursday,
June 20, 2013
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
Verification and Validation of Healthcare Processes This webinar will cover verification and validation techniques in variety of industries. It includes strategies and methods most suitable for healthcare and its goal of "first, do no harm." Included in the webinar are how to form teams, how to manage teams, how to plan, management responsibilities, and risk assessment. Live
Thursday,
June 20, 2013
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
How to Deal With the Disruptive Practitioner This webinar will discuss the development of such a policy, including a statement in the medical staff bylaws to the effect that each member of the staff is expected to comply with all of the hospital and medical staff rules, regulations, policies and procedures relating to behavior and performance. It is also important to make sure that the policy makes it clear that failure to do so will subject the member to sanction under the corrective action procedure delineated in the bylaws and/or fair hearing plan. Live
Tuesday,
June 25, 2013
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
Webinar on Patient Centered Care In its Declaration on Patient-Centered Healthcare, The International Alliance of Patients' Organizations (IAPO) states that the essence of patient-centered healthcare is that the healthcare system is designed and delivered to address the healthcare needs and preferences of patients so that healthcare is appropriate and cost-effective. The Declaration sets out five principles of patient-centered healthcare: respect; choice and empowerment; patient involvement in health policy; access and support and information. Live
Tuesday,
June 25, 2013
10:00 AM PDT | 01:00 PM EDT,
Duration:60 Minutes
In this session we will discuss the HIPAA audit and enforcement processes and how they apply to covered entities and business associates, and the new random HIPAA compliance audit program in particular. We will review the new audit processes and discuss what will be asked in an audit and how. Protocols and the questions asked at recent audits will be explained. Recorded
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Duration:90 Minutes
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. Recorded
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Duration:90 Minutes
The New Final HIPAA Breach Notification Rule that becomes enforceable on September 23, 2013 requires all HIPAA covered entities and business associates to follow a number of steps to be in compliance. Recorded
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Duration:90 Minutes
With the new HIPAA random audit program now getting under way, and increases in enforcement actions following breaches, now is the time to ensure your organization is in compliance with the regulations and meeting the e-mail and texting communication needs and desires of its providers and patients. You need the proper privacy protections for health information, and the necessary documented policies and procedures, as well as documentation of any actions taken pursuant to your policies and procedures. Your policies and procedures will probably need major revisions to maintain compliance in areas such as individual access of records, accounting of disclosures, and breach notification. And, of course, you will need to train your staff in all the new policies and procedures. Recorded
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Duration:90 Minutes
In this session we will discuss the HIPAA Audit Protocol to see what kind of questions it has within it, and what needs to be done to be able to answer those questions. We will review the new audit processes and discuss what will be asked in an audit and how. Protocols and the questions asked at recent audits will be explained. Recorded
View Anytime
Duration:90 Minutes