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Excel Spreadsheet Validation for FDA 21 CFR Part 11
8/12/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
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Summary:

This webinar will describe the regulatory and business requirements for Excel spreadsheets, using examples from FDA recommendations. It will then cover the design and installation of those Excel Spreadsheets, to ensure the integrity of the data, and will discuss how to ensure 21 CFR 11 compliance during the development, installation and maintenance of a spreadsheet application.

ICH GCPs and the Clinical Research Process Including Phase 0123 and Phase 4 trials
8/12/2014 10:00 AM - 11:30 AM
Online Event Fremont, California United States
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Summary:

This webinar presents a comprehensive overview of the ICH GCP and other clinical requirements for conducting clinical trials. Learn about the ICH GCP, use of the ICH GCP during clinical trials and the general concepts upon which clinical trials are based. This webinar allows clinical professionals to prepare for and conduct clinical trials.

Hack Night
8/12/2014 6:00 PM - 10:00 PM
Assembly Coworking Space Calgary Canada
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Summary:

Every Tuesday night from 6pm to 10pm, “Hack Nights” come alive with hustlers, hackers and hipsters coming together to work on their start-up ideas. If you are working on something tech related, and are in the pre-investment stage, this event is for you!

Weekly Open Make Night
8/12/2014 6:00 PM - 9:00 PM
Tampa Hackerspace Tampa, Florida United States
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Summary:

Lets get together to build some cool projects and meet some very cool people. Join us to work on your stuff, bounce ideas off of members and socialize.

Occasionally, we'll throw in a small class.

Morning Startup
8/13/2014 7:30 AM
Spacecubed Perth Australia
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Summary:

The early riser's information injection. Morning Startup is the most popular of Perth's startup meetups. An excellent networking opportunity and a good selection of speakers.

Get Ready For the New HIPAA Audit Program Webinar By MentorHealth
8/13/2014 10:00 AM - 11:30 AM
online event Fremont, California United States
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Summary:

Overview: In this session we will discuss the HIPAA audit program and how it works, and discuss the areas that caused the most issues in the 2012 audits. We will explore what kind of issues and what kind of entities had the most problems, and show where entities need to improve their compliance the most.

We will also explore the typical risk issues that lead to breaches of health information and see how those issues may be a target for auditors in 2014

We will review the contents of the HIPAA Audit Protocol used in 2012 to show what documentation needs to be on hand should your organization be selected for an audit in 2014

The HIPAA Audit Protocol is not easy to use in its incarnation as a Web-based tool, and it does have several deficiencies because of the changes in the rules that became enforceable September 23, 2013. We will present methods for using the contents of the HIPAA Audit Protocol to build your own compliance plan by extracting and updating the contents and relating your compliance activities directly to the questions that might be asked

In this session we will discuss the HIPAA audit and enforcement regulations and processes, and how they apply to HIPAA covered entities and business associates. We will explain the enforcement regulations and the recent changes that increase fines and create new penalty levels, including new penalties for willful neglect of compliance that begin at $10,000

We will discuss what information and documentation must be prepared in advance so that you can be ready for an audit at any time, including sample information request forms and questions asked at prior audits

The session will also cover how to know if you may become the subject of an audit or enforcement action, and what you can do to help limit your exposure. We will discuss how most enforcement actions come about and what can be done to prevent incidents that lead to enforcement activity

The HIPAA Privacy, Security, and Breach Notification regulations (and the recent changes to them) and how they will be audited will be explained. Documentation requirements for compliance will be explored and a framework of security policies necessary for compliance will be presented

The HIPAA Audit Protocol questions will be explored and ways of using the content to develop a compliance plan will be discussed. The process of exporting the questions will be shown, and a sample spreadsheet showing the results will be presented

The results of prior HHS audits (and their penalties) will be discussed, including recent actions involving multi-million dollar fines and settlements. A plan for attaining compliance will be presented. The steps to follow to prepare for an audit and respond to an audit request will be outlined

Why should you attend:

While in the past, audits had been performed only at entities that reported a breach or had a compliant filed against them, the new rule calls for audits whether or not there is a complaint or breach. This means that the HHS Office for Civil Rights (OCR) can show up and ask to perform an audit on short notice, and your organization will need to provide a response in less than ten business days. Knowing what questions are likely to be asked and have been asked at prior HIPAA compliance audits can make preparing for and surviving a HIPAA audit much easier.

USDHHS has published the protocol used for the 2012 HIPAA audits by the HHS contractors, so it is possible to know much better now how to prepare for an audit. Nearly any health care covered entity may be subject to an audit; all entities need to know what kinds of questions they'll be asked, what information they'll need to provide and how to prevent issues that could lead to violations and fines.

Areas of weakness as shown in the 2012 audits and as shown by breach reports are likely targets for the next round of audit questions, and HHS is sending out requests for information to 1200 covered entities and business associates to determine their suitability to be audited.

If your organization is not ready, the HIPAA rules have new, significantly higher fines, including mandatory minimum fines of $10,000 for willful neglect of compliance. In addition, HIPAA enforcement has taken on a new importance at HHS; officials have publicly stated that enforcement is now a priority, and that means being ready for an audit is more important than ever. The "slap-on-the-wrist" days are over and fines and settlements are being levied, with more on the way -- don't let your organization be hit for an audit unprepared.

Areas Covered in the Session:

Find out what the audit process is, what HHS OCR is likely to ask you if you are selected for an audit, and what you'll have to have prepared already when they do

Learn how to make the HIPAA Audit Protocol useful to you as a way to organize and track your compliance work, and collect your documentation references

Find out what you'll need to have documented to survive an audit and avoid fines

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

Learn about the training and education that must take place and be documented to ensure your staff uses health information 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 how you must be prepared or risk significant penalties

Who Will Benefit:

Compliance Director

CEO

CFO

Privacy Officer

Security Officer

Information Systems Manager

HIPAA Officer

Chief Information Officer

Health Information Manager

Healthcare Counsel/lawyer

Office Manager

Background :

The random HIPAA Compliance Audit program had a year of trial audits in 2012. The US Department of Health and Human Services has reviewed the results of that work and the HIPAA audit program is being restarted in 2014 based on what was learned from the 2012 audits.

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.

How to Properly Handle HIPAA Security Incidents and Actual Breaches Webinar By MentorHealth
8/13/2014 10:00 AM - 11:30 AM
online event
Event Listing
Summary:

Overview: The word "breach" in the health care industry, and for those business associates of covered entities, certainly causes alarm when not only have you had your patient's privacy violated, but also now you have to prepare for the financial cost to remedy the breach and think about the possible criminal and civil penalties that you or your organization may have to face.

In addition, because the HITECH Act for the first time now authorizes a federal lawsuit for a HIPAA violation, an aggrieved individual may ask the attorney general of the state in which the violation occurred to sue on his behalf in federal court and recover damages, attorney's fees, and costs. As of the end of August 2011, the Connecticut Attorney General ("AG") had filed two such lawsuits and the Indiana AG had filed one.

In the first one filed, the Connecticut AG obtained a $250,000 settlement from the hospital defendant. Thus, a covered entity now faces the possibility of HIPAA lawsuits in both state and federal courts. Further, with the HITECH Act's expansion of HIPAA civil and criminal liability to business associates, the latter may also be sued in federal court. The Minnesota Attorney General has filed such a lawsuit against a business associate. Isn't it better to know the proper way to handle a breach according to the law?

Learn the difference between security incident reports and reportable breaches and how to handle each properly during this 90-minute seminar. Find out what resources are available to you to help avoid breaches of confidentiality and how your organization can be better prepared for HIPAA compliance regulations

Areas Covered in the Session:

What is a security incident?

What is a breach?

What immediate action should be taken when a breach is suspected?

How to report a breach

How to investigate a breach

How to mitigate the harm of a breach

What breaches must be reported to DHHS and/or to the individuals who are the subject of the breach?

How to report breaches to DHHS and/or to the individuals who are the subject of the breach

How to determine whether disciplinary action is appropriate

How to document security incidents and breaches in a security incident report

Do you need insurance to cover HIPAA breaches?

Who Will Benefit:

HIPAA Compliance Officers

HIPAA Security Officers

HIPAA Privacy Officers, CFOs

CIOs

Medical Records Personnel

Health Information Management Professionals

Health Care Attorneys

Billing Services

Educational Objectives(S)

Upon completion of this activity, participants will be able to:

Discuss the difference between security incident reports and reportable breaches and how to handle each properly.

CME Credit Statement

This activity has been planned and implemented in accordance with the Essential Areas and Policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of CFMC and MentorHealth. CFMC is accredited by the ACCME to provide continuing medical education for physicians.

CFMC designates this educational activity for a maximum of 1.5 AMA PRA Category 1 Credits™. Physicians should only claim credit commensurate with the extent of their participation in the activity.

Other Healthcare Professionals Credit Statement

This educational activity has been planned and implemented following the administrative and educational design criteria required for certification of health care professions continuing education credits. Registrants attending this activity may submit their certificate along with a copy of the course content to their professional organizations or state licensing agencies for recognition for 1.5 hours.

Disclosure Statement

It is the policy of CFMC and MentorHealth that the faculty discloses real or apparent conflicts of interest relating to the topics of the educational activity. All members of the faculty and planning team have nothing to disclose nor do they have any vested interests or affiliations

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Obtaining Certificate of Credit

Colorado Foundation for Medical Care (CFMC) hosts an online activity evaluation system, certificate and outcomes measurement process. Following the activity, you must link to CFMC's online site (link below) to complete the evaluation form in order to receive your certificate of credit. Once the evaluation form is complete and submitted, you will be automatically sent a copy of your certificate via email. Please note, participants must attend the entire activity to receive all types of credit. Continuing Education evaluation and request for certificates will be accepted up to 60 days post activity date. CFMC will keep a record of attendance on file for 6 years.

Background :

A number of HIPAA standards require covered entities and now, by virtue of the HITECH Act and the Omnibus Rule, to have policies and procedures to handle HIPAA security incidents, even those that do not result in an actual breach of confidentiality. The largest civil money penalties are reserved for breaches that are not handled properly.

Richard D. Dvorak J.D., is a health care attorney and partner in the law firm of TOMES & DVORAK, CHARTERED, a Kansas City area law firm. The firm has Martindale-Hubbell’s highest rating, AV (“A” is for preeminent in the field of practice and “V” is for highest ethics). After serving eight years in the United States Marine Corps, Richard obtained his law degree from Chicago-Kent College of Law in 1992. He is licensed to practice law in Illinois, Missouri, and Kansas, including various U.S. federal courts. Mr. Dvorak’s extensive litigation experience includes medical malpractice, physician licensure, mental health disability cases, military cases, and criminal cases, among others.

Mr. Dvorak is Vice President of EMR Legal, Inc., a national HIPAA consulting firm, which provides consulting services for clients ranging from a large county government, with eight different health entities that need HIPAA compliance help, to a small transcription service. His specialty is helping covered entities and business associates comply with HIPAA in a cost-effective manner using his extensive technical computer knowledge and business acumen. He and his team have consulted over 1,000 clients in health care regulations since 1998. Mr. Dvorak is also the Vice President of Veterans Press, Inc.—a national publishing company that sells and distributes The Compliance Guide to HIPAA and the DHHS Regulations, soon to be in the 6th edition, an integral part of the HIPAA Compliance Library.

A Design Control Primer
8/13/2014 10:00 AM - 11:00 AM
Online Event Fremont, California United States
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Summary:

This webinar will cover the basics of design controls, and provide recommendations for implementation of a compliant design control system. Also discussed will be deisgn control requirements for devices already in distribution. Documentation requirements for each design stage will be included as well.

Lean Startup Circle Asheville
8/13/2014 4:30 PM - 6:30 PM
Mojo Coworking Asheville, North Carolina United States
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Summary:

Focused on teaching and talking about Lean Startup principles. Second Wednesday of every month.

How to Get Your Combination Product Approved and onto the US Marketplace
8/14/2014 9:00 AM - 8/15/2014 6:00 PM
WILL BE ANNOUNCED SOON San Francisco, California United States
Event Listing
Summary:

This course provides a comprehensive understanding of the FDA Combination Product system. Participants receive a foundation of knowledge about the FDA Office of Combination Products, the FDA Combination Product system, Combination Product submissions, and the scientific and regulatory principles involved.

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