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FDA Acceptance of Foreign Clinical Studies Not Conducted Under An IND
4/25/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
Event Listing

This session covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States, as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.

Founder Talk Frank White Decoding the Investment Term Sheet
4/23/2014 12:00 PM - 1:30 AM
CIE Pensacola, Florida United States
Event Listing

Decoding the

Term Sheet- addressing typical structures and legal terms

in angel and VC investments

Price: FREE

FredLug Meetup
4/26/2014 9:00 AM - 11:00 AM
England Run Library Fredericksburg, Virginia United States
Event Listing

A Linux Users Group to meet and talk about Open Source and Linux. We discuss a variety of subjects from very technical to high level all concentrated in providing IT solutions using Open Source and Linux.

From Enterprise Service Bus ESB to Internet Service Bus ISB
5/21/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
Event Listing

We have successfully built and integrated service based applications. Now we want to deploy them in the cloud and take advantage of commercial, cloud-based applications, but the integration challenges become much more complicated than between on-premise applications. Recent surveys show, for example, that companies abandon SaaS solutions because of problems integrating SaaS with on-premise applications.

G60 Pitch Contest 21C Bentonville
4/21/2014 5:30 PM - 7:30 PM
21c Museum Hotel Bentonville, Arkansas United States
Event Listing

The G60 Pitch Contest is an event created to promote startups, improve founder communication skills, and to increase "creative collisions" in emerging entrepreneurial ecosystems.

Gateway to Innovation Conference
4/23/2014 7:00 AM - 4:15 PM
Hyatt Regency St. Louis at the Arch St. Louis, Missouri United States
Event Listing

The 2014 Gateway to Innovation Conference brings IT Leaders and thinkers together from across the nation to inspire, collaborate and gain the competitive edge in an industry that demands more for less.

Price: 350

Getting Your Business Started with Open Source Webinar By EITAGlobal
4/17/2014 10:00 AM - 11:30 AM
Online Event(World wide) Fremont, California United States
Event Listing

Overview: This session will serve as a primer for individuals and organizations interested in open source software, and its ability to meet their business needs. Attendees will gain a better understanding of what open source software is, how it is developed, its characteristics that may be beneficial to their organization, and considerations for successful adoption.

Non-technical managers will enhance their ability to work with and support their technical staff in planning and implementation. This session is delivered in non-technical language with an emphasis on helping you determine the business case for your organization. The session will also provide a basic framework for planning. Materials include resources for further investigation.

Google Glass with Wes Hardaker Linux Users Group of Davis Lugod
4/21/2014 7:00 PM - 9:00 PM
Davis Public Library Davis, California United States
Event Listing

Google Glass is a wearable computer with an optical head-mounted display (OHMD) that is being developed by Google in the Project Glass research and development project, with a mission of producing a mass-market ubiquitous computer. Google Glass displays information in a smartphone-like hands-free format, that can communicate with the Internet via natural language voice commands.

HIPAA Enforcement and Portable Devices Today
5/13/2014 10:00 AM - 11:30 AM
online event Fremont, California United States
Event Listing

Overview: It seems everyone is moving to a new smart phone and wants to use it in all the incredible ways it can be used, including for health care purposes. New health care apps are being released all the time, and even good old e-mail is being used more and more to communicate, by providers and patients alike.

In order to integrate the use of mobile technology into patient communications, it is essential to perform the proper steps in an information security compliance process to evaluate and address the risks of using the technology. This session will describe the information security compliance process, how it works, and how it can help you decide how to integrate mobile technology into your organization in a compliant way. The process, including the use of information security risk analysis, will be explained, and the policies needed to support the process will be described.

But the process must also include consideration of various patient access requirements in the HIPAA Privacy Rule. There are new requirements to provide patients electronic access of electronically held PHI which raise new questions of how that access will be provided and how the information will be protected during and after access. And there has long been a HIPAA requirement for covered entities to do their best to meet the requests of their patients for particular modes of communication, and using a mobile device is no exception.

The stakes are high – any improper exposure of PHI may result in an official breach that must be reported to the individual and to the US Department of Health and Human Services, at great cost and with the potential to bring fines and other enforcement actions if a violation of rules is involved. Likewise, complaints by a patient if they are not afforded the access they desire can bring about HHS inquiries and enforcement actions, so it is essential to find the right balance of access and control.

HHS compliance audit activity and enforcement penalties are both increased, especially in instances of willful neglect of compliance, if, for instance, your organization hasn't adopted the complete suite of policies and procedures needed for compliance, or hasn’t adequately considered the impact of mobile devices on your compliance. Given that mobile devices are a leading source of breaches of PHI, it is essential to consider these devices and how their use affects the privacy and security of PHI; not doing so is inviting enforcement action by HHS.

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.

Areas Covered in the Session:

Find out the ways that patients want to use their mobile technology to communicate with providers, and the ways providers want to use their mobile technology to enable better patient care.

Learn what are the risks of using mobile technology, what can go wrong, and what can result when it does.

Find out about HIPAA requirements for access and patient preferences, as well as the requirements to protect PHI.

Learn how to use an information security management process to evaluate risks and make decisions about how best to protect PHI and meet patient needs and desires.

Find out what policies and procedures you should have in place for dealing with mobile devices and any new technology.

Learn about the training and education that must take place to ensure your staff uses mobile devices properly and does not risk exposure of PHI.

Find out the steps that must be followed in the event of a breach of PHI.

Learn about how the HIPAA audit and enforcement activities are now being increased and what you need to do to survive a HIPAA audit.

Who Will Benefit:

Compliance Director



Privacy Officer

Security Officer

Information Systems Manager

HIPAA Officer

Chief Information Officer

Health Information Manager

Healthcare Counsel/lawyer

Office Manager

Jim Sheldon-Dean is the founder and director of compliance services at Lewis Creek Systems, LLC, a Vermont-based consulting firm founded in 1982, providing information privacy and security regulatory compliance services to a wide variety of health care entities.


Phone No: 800-385-1607

FaX: 302-288-6884

Event Link:

HIPAA Issues in Mental and Behavioral Health Webinar By MentorHealth
5/1/2014 10:00 AM - 11:31 AM
online training Fremont, California United States
Event Listing

Overview: Without the proper legal awareness needed to stay in compliance, you may face grave legal and financial consequences. This webinar will help alleviate confusion by providing an overview of HIPAA and the Security and Privacy Rules and the changes that the HITECH Act caused, especially regarding civil and criminal penalties for violating HIPAA. Learn how and when HIPAA preempts (does away with) state law and the exceptions to preemption, and what other laws preempt HIPAA, such as 42 Code of Federal Regulations Part II's added protection for substance abuse treatment information.

Gain insight on the Security Rule issues for mental and behavioral health practitioners in terms of the five categories of security requirements: general provisions, administrative safeguards, physical safeguards, technical safeguards, and documentation requirements. Understand the privacy rights of clients under HIPAA, specifically the individual's right of access to protected health information ("PHI"), the individual's right to an accounting of uses and disclosures of PHI, the individual's right to notice of information practices, the individual's right to request restriction of uses and disclosures of PHI, and the individual's right to request correction/amendment of PHI.

The information presented is valuable legal and practical information on how to comply with the laws and regulations that haunt your daily duties. Social workers, psychologists, psychiatrists, counselors, addiction professionals, case managers, health care administrators, privacy officers, security officers, CFO's and risk managers will acquire useful knowledge and solutions to your compliance nightmares and fears of ethics violations, litigation, depositions, and court room testimony. This program will boost your confidence in all of these areas and help you continue to provide "top shelf" care, treatment and advice to your clients. Focus your energies where they count the most and gain the expertise you need to meet the requirements of HIPAA, the HITECH Act, and Omnibus Rule change. Become and remain confident that your Mental and Behavioral health care practice is on the right track.

Why should you attend: The Health Insurance Portability and Accountability Act of 1996 ("HIPAA") and its implementing Department of Health and Human Services ("DHHS") regulations, primarily the Security Rule and the Privacy Rule, however, greatly complicate many important issues, such as whether a clinician could release a second opinion by another clinician to the client under the client's HIPAA right of access or whether HIPAA's narrow exception to disclosure to the client if the disclosure would be reasonably likely to result in death or serious injury would prohibit the disclosure if it would impair the therapeutic relationship.

Much of this type of confusion comes from HIPAA's preemption standard. HIPAA preempts (does away with) other state or federal law that is inconsistent with HIPAA unless, among other grounds, the state or federal law provides more privacy protection. One of the problems, for example, is figuring out whether a state law saying that a psychologist may not release a third-party document to the patient provides more or less privacy protection.

Areas Covered in the Session:

Group therapy

Disclosure to law enforcement and others when the client presents a danger to him or herself or others including interaction with the Tarasoff duty to warn

Denying client chart access

What to do if your client's records contain information about other family members

Whether you can discuss a client's case with another clinician without a signed consent

When you must disclose psychotherapy notes

May you release copyright protected raw test data?

Questions and answers

Who Will Benefit:

HIPAA Compliance Officers

HIPAA Security Officers

HIPAA Privacy Officers


Human Resources Directors

Medical Records Personnel

Psychologists, Psychiatrists

Licensed Clinical Social Workers

Mental and Behavioral Health Practitioners

Jonathan P. Tomes , J.D., is a health care attorney and partner in the law firm of TOMES & DVORAK, CHARTERED. He has written more than 50 books, including The Compliance Guide to HIPAA and the DHHS Regulations, and dozens of articles in the area of HIPAA compliance.


Phone No: 800-385-1607

FaX: 302-288-6884

Event Link:

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