Rule Web-based Seminars

HIPAA Breach Notification How to Prevent Prepare for and Report Breaches of Healthcare Information Privacy and Security - Webina We will discuss the kinds of threats that exist for PHI and how they're changing as the hackers gain experience and abilities, and why you need to prepare for next-generation attacks now. Wednesday, December 7, 2011 10: 00 AM PST | 01: 00 PM EST  more...

HIPAA Security Rule Compliance When Communicating with Patients Using Mobile Devices - Webinar By mentorhealth The session will discuss the requirements, the risks, and the issues of the increasing use of mobile devices for patient communications and provide a road map for how to use them safely and effectively, to increase the quality of health care and patient satisfaction. Tuesday, November 29, 2011 10: 00 AM PST | 01: 00 PM EST  more...

HIPAA Privacy Policies and Procedures Prepare for Updates and New Requirements - Webinar By mentorhealth Learn how having good policies and procedures and good documentation can make compliance easier. Thursday, October 6, 2011 10: 00 AM PDT | 01: 00 PM EDT  more...

HIPAA Accounting of Disclosures Expanded scope in proposed rule means new obligations The session will walk the listener down the path from the current HIPAA Accounting of Disclosures rule, through the HITECH Act's required changes, and the into the proposed rule to implement HITECH which goes beyond what was required in the law and establishes a new right to an Access Report of all electronic PHI.  more...

HIPAA Accounting of Disclosures Expanded scope in proposed rule means new obligations by gcp The session will walk the listener down the path from the current HIPAA Accounting of Disclosures rule, through the HITECH Act's required changes, and the into the proposed rule to implement HITECH which goes beyond what was required in the law and establishes a new right to an Access Report of all electronic PHI.  more...

HIPAA and Security Breaches Most frequent issues and causes and trends for future threats by GCP The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI and report and document it properly. We will discuss the origins of the rule and how it works, including interactions with other HIPAA rules and penalties for violations  more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products-GCP This webinar will provide valuable assistance and guidance to device companies in involved in commercialization of combination products.  more...

FDAs final Medical Device Data System Rule FDA's promulgation of Electronic Medical Records, introduction of Meaningful Use and desire to automatically acquire medical device data for inclusion in electronic records has resulted in the development of Medical Device Data Systems.  more...

Understanding and Implementing FDAs 21 CFR Part 11 - Webinar By GlobalCompliancePanel ... electronic signatures and handwritten signatures. The rule applies to all industry segments regulated by the FDA that includes Good Laboratory Practice (GLP), Good Clinical Practice (GCP) and current Good Manufacturing Practice (cGMP). Even though the rule is more than 10 years old there are still many questions related to the scope and real requirements of Part 11. Attendees of this  more...

HIPAA Security Policies and Procedures Making them useful and relevant as well as compliant - Webinar By GlobalCompliancePanel ...ity regulation and the process used in complying with the rule, which leads, inevitably, to the adoption of policies and procedures. With the expansion of electronic devices and systems in use for health care, remote access and use of data now require special attention to secure protected health information, and special policies and procedures as well, especially now that portable devices  more...

Information Security and Payment Card Rules Protecting Patient Payment Data and Complying with PCI - Webinar By GlobalCompliance ...tection and how the PCI DSS relates to the HIPAA Security Rule - there are substantial similarities, and being prepared for one helps you prepare for the other, as well as for other requirements, such as breach notification. We will discuss how the regulations and standards work and their legal basis, as well as provide up-to-date information on any expected changes. Attendees will learn  more...

Information Security Risk Analysis Meeting HIPAA Requirements and the Meaningful Use Objective - Webinar By GlobalCompliancePane ...n method identified in the preamble to the HIPAA Security Rule and guidance from the US Department of Health and Human Services. Areas of high risk, as identified by respected industry organizations, will be identified to ensure that the most significant risks are discovered and adequately prioritized. The risk analysis process will be applied to a simplified example in order to relate the  more...

HIPAA Breach Notification What to do to prevent breaches and what to do when they happen to you - Webinar By GCPanel ...Rule required by the HITECH Act within the American Recovery and Reinvestment Act of 2009 went into effect September 23, 2009, requiring all HIPAA covered entities and business associates to follow a number of steps to be in compliance. * The HIPAA Breach Notification Rule has been in effect since September 23, 2009 and most organizations are not prepared to respond to a breach of PHI  more...

Food Drug Cosmetic Act Implementing Regulations Major New Laws - An Overview - Webinar By GlobalCompliancePanel ...of OTC Monographs o Tamper Resistant Packaging Rule o Nutrition Labeling & Education Act (NLEA) o Dietary Supplement Health & Education Act (DSHEA) o OTC Drug Facts Labeling Rule o Bioterrorism Act o Food Safety Modernization Act Who will benefit: Anyone who wants or needs basic background on the Food, Drug & Cosmetic Act and  more...

FDAs Proposed Rule Regarding Device Establishment Registration and Listing and How to Register and List - Webinar By GlobalCompl ...performed on those devices. FDA issued a 28-page Proposed Rule that would amend its regulations regarding medical device establishment registration and device listing (the Proposed Rule).The Proposed Rule contains four types of proposed changes to FDA's device establishment registration and device listing regulations. For example, Proposed Rule would amend FDAa ™s current regulations to  more...

Using Foreign Trial Data in Your NDA Approval Process - Webinar By GlobalCompliancePanel ...of foreign trial data and know how FDA implementing these rule along with design considerations and requirements for foreign trials. Why you should attend: While the law allows 100 percent of pivotal data to come from foreign trials, there have been very few such submissions accepted by FDA - mainly in limited therapeutic areas. Given lower costs and shorter recruiting times, the use of  more...

Complying with HIPAA Security Rules Whats in the rules and how you can most easily prepare for compliance - Webinar By GlobalCom ...ata devices. Why you should attend: The HIPAA Security Rule, in place and as proposed in amendments going into effect in 2011, calls for all Covered Entities and Business Associates, and their subcontractors, to be in compliance with provisions protecting all kinds of electronic protected health information. While many entities have gone through the processes necessary for HIPAA Security  more...

Water System Biofilm Control and Microbial Monitoring Myths - Webinar By GlobalCompliancePanel ...d. You will probably be surprised to learn which of your "rules of thumb" are actually quite wrong! Perhaps you will find out why you are having microbial problems in spite of using supposedly microbial-controlling designs and approaches! Perhaps you will find out that you have been doing costly, useless, and scientifically unjustifiable testing that can be stopped. You probably cannot afford  more...

New Changes to HIPAA The latest changes in the regulations and what they mean to you - Webinar By GlobalCompliancePanel ...es to see of they are prepared to meet the changes in the rules. Covered entities that use electronic health records (EHRs) will need to meet new access and disclosure rules and all kinds of business associates and their subcontractors will need to establish compliance programs. And the regulations include new requirements for audits by the US Department of Health and Human Services and  more...

HIPAA Compliance and Workforce Training for Medical Practices - Webinar by GlobalCompliancePanel ... implementations at medical offices. The HIPAA Privacy Rule includes basic protections of uses and disclosures of protected health information that every staff member must be aware of, from avoiding discussion of patient-related information outside of the office, to taking precautions when faxing information to another office. Beyond the use and disclosure provisions, there are requirements  more...

FDAs Update on Medical Device Labeling Changes - Webinar by GlobalCompliancePanel ...rule regarding the parameters in which a device manufacturer can modify label changes to a product. Specifically, manufacturers can add or strengthen the contraindications, warnings, precautions or adverse reactions sections of labeling via a PMA supplement without prior FDA approval only when such modifications are based on newly acquired information and evidence of a causal association  more...

Medical Device Classification - Webinar by GlobalCompliancePanel ...onal sy The EUa ™s MDD classifies devices using a rule based system found in Annex IX of the MDD. Devices fall into four risk categories (I, IIa, IIb, and III). The risk class of the device determines the available conformity paths the manufacturer may use to affix the CE mark. This webinar explains the risk classification and conformity paths using the MDD version in effect after March  more...

Combination Products FDAs Proposed Rule for GMP Requirements and Introduction and Expectations for Combo Products - Webinar by G ...ed during this Webinar, including recently FDA's proposed rule to codify the current good manufacturing practice (cGMP) requirements applicable to combination products. This proposed rule is intended to promote the public health by clarifying which cGMP requirements apply when drugs, devices, and biological products are combined to create a combination product. In addition, the proposed rule  more...