Monthly Archive: March 2014

Avoid Financial Sanctions with the Proper HIPAA/HITECH Compliance Plan

Doctors Studying Data on ComputerThe Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Health Information Technology for Economic and Clinical Health Act of 2009 (HITECH) as amended by the HIPAA Omnibus Rule in 2013 define the regulations for the private and secure management of health information. Covered entities and business associates that neglect adhering to these regulations can face rigid sanctions from a multitude of agencies, including the U.S. Department of Health and Human Services (HHS), its Office for Civil Rights (OCR), the Federal Trade Commission and state Attorneys General.

Each regulatory agency can impose fines against covered entities and business associates that fail to document, investigate and remedy HIPAA and HITECH violations. Without the proper compliance planning, covered entities and business associates can be slammed with heavy financial penalties and regulatory oversight, as happened to Cignet Health of Prince George’s County in Maryland.

Learning from the past

According to Healthcare ITNews, Cignet denied 41 patients access to their medical records between September 2008 and October 2009, a right guaranteed by the HIPAA Privacy Rule. Cignet further failed to cooperate with OCR’s investigation of the patients’ complaints and with HHS’ subpoena for the records, which was enforced by the District Court.

The court levied a $1.3 million fine against Cignet for failing to grant access to the patients’ records, and an additional $3 million for willful neglect of the HIPAA Privacy regulations.

The time for proper HIPAA and HITECH compliance planning is now.

Training modules available

“HIPAA and HITECH, Pathway to Compliance” is a four-part do-it-yourself instructional series that guides its users in drafting a HIPAA/HITECH Compliance Plan. Each part provides regulatory information and resources necessary to build a customized plan. Documentation developed in this series can be used when faced with OCR investigations and/or audits to demonstrate compliance efforts.

In this series, Patricia Wynne, Esq., CIPP, a seasoned HIPAA/HITECH subject matter expert familiar with the day-to-day challenges of compliance, presents guidelines for drafting a Compliance Plan that are easy to understand and practical to implement – not bogged down in technical jargon. Each course is one hour in length and includes case studies and questions to enhance learning, as well as resources that can be downloaded and used in the compliance planning process. Now is the time to build your HIPAA/HITECH Compliance Plan with the professional insight of Merit Career Development. Click here to learn more.


© 2014 Merit Career Development. All rights reserved. For more information, please contact Jim Wynne at jwynne@MeritCD.com.

Permanent link to this article: http://meritcd.com/blogs/avoid-financial-sanctions-with-the-proper-hipaahitech-compliance-plan/

Risk Management in the Biotech and Pharmaceutical Industries

Risk management in the pharmaceutical industry

The biotech and pharmaceutical industries are no strangers to risk – organizing clinical trials for medications that may never reach the open market due to inefficiency can place a significant financial burden on companies. When it comes to managing them, identifying procedures can be essential to avoiding or minimizing the financial impact of risks.

The Economist Intelligence Unit conducted a survey of senior management executives in the pharmaceuticals and life sciences industry regarding risk in their respective companies. The 65 responses were combined with those of an earlier survey of 353 executives in a wider range of other industries. It mainly focused on North America, with 65 percent of respondents hailing from the region, but also included international areas such as Europe, Asia-Pacific, Africa and Latin America.

Management is C-level

According to its findings, the EIU reported that the ultimate responsibility of risk management was falling on CEOs, CFOs, CROs and general counsel. The survey found that the senior executives could be doing a better job of defining the company’s interest in risk, ensuring that information gets to the appropriate people for assessment.

Most time spent on compliance

Following controls and monitoring, compliance takes up most of their time with risk management. However, this leaves managers and executives with less freedom to watch for emerging threats that could create financial hardships. As a result, companies are failing to spread risk awareness throughout their organizations.

Mismatch between barriers, risk processes

The results showed that two-thirds of respondents had no intention of recruiting a chief risk officer, with less than one-third saying their organization has one on staff already. While breaking down the risk management silo may have been beneficial, the lack of awareness diminishes an organization’s ability to understand new risks.

The benefit of third-party training

According to the U.S. Food and Drug Administration, quality systems are becoming integral to the pharmaceutical industry. In turn, risk management is a valuable component of an effective quality system.

The biotech and pharmaceutical industries can greatly benefit from outsourcing their risk management training to third-party experts. Merit Career Development offers courses specific in project risk management for the biotechnology and pharmaceutical industries. For more information, click here.

The EIU study underscores the advantages that extra training can bring to risk management in the pharmaceutical industry. With a healthy roster of subject matter experts, Merit can help executives not only manage current threats but also look ahead to potential emerging risks.

 

© 2014 Merit Career Development. All rights reserved. For more information, please contact Jim Wynne at jwynne@MeritCD.com.

Permanent link to this article: http://meritcd.com/blogs/risk-management-in-the-pharmaceutical-industry/

Customer Conversations

A two-step learning experience to boost listening skills

Customer ConversationsWhat do you do when your own field technicians can’t seem to communicate effectively with your customers? That was the challenge faced by a large global technology company who came to Merit Career Development for a solution.

The answer was a two-step process: measure employees’ listening skills and follow-up with a two-hour webinar reinforcing the key aspects of listening and interacting with customers.

The goal: empower field technical personnel to manage client conversations to ensure accurate communications and to create satisfied customers.

Measuring. We first asked employees to complete a simple assessment to gauge their listening skills. The Listening Skills Assessment (LiSA) measures three related aspects of listening: understanding the overall situation, attention to detail, and inferring personal interpretation.

Students watch realistic technology-related video scenarios and answer questions about the big picture, details about the situation and what they think was really going on in the example. It’s interactive and fun.

Before the webinar, students receive the results of their listening assessment. This establishes the baseline for the training session, the focus of which reinforces the key aspects of listening measured by the assessment.

Learning. The goal of the two-hour interactive webinar is to increase students’ self-awareness of their verbal and written communication styles as they work with customers. But it’s more than that. How can employees show they are really attending to the customer and want to leave both sides of the interaction satisfied?

Students learn how to observe non-verbal communication cues and follow-up on them, strengthening the customer relationship by showing good attention skills. Important listening skills like asking open-ended questions, reflecting back to the speaker, paraphrasing and summarizing help the individual obtain accurate information from the customer and make sure the employee is getting the real message.

And the webinar covers more than just verbal communication skills. It also highlights effective electronic communications. Students learn how to create effective and appropriate electronic messages, write messages that are clear, concise, coherent, and to project a positive voice image. These are all crucial communication skills in today’s business environment.

In the end, participants leave the course being more self-aware and carrying some new tools to use in effective customer communication.

To learn more about how Merit Career Development can solve your business challenges please contact us.

 

© 2014 Merit Career Development. All rights reserved. For more information, please contact Jim Wynne at jwynne@MeritCD.com.

Permanent link to this article: http://meritcd.com/blogs/customer-conversations/

Merit’s April 2014 Book Giveaway

Checklist ManifestoAt Merit, we read a lot. From current thought leaders, to the latest research on critical management skills and adult learning theory. The concepts in these books inform our professional education programs. This month we’d like to give away another of our favorites, The Checklist Manifesto.

Through a gripping story-telling narrative, acclaimed surgeon and writer Atul Gawande, illustrates the value of checklists in multiple scenarios. We learn how the simple idea of a checklist can make the difference, literally, between life and death, and how it’s crucial for any high stakes environment. The Checklist Manifesto is an easy read, but don’t miss it.

Click here to enter Merit’s Monthly Book Giveaway

The deadline for entries is April 15, 2014.

Permanent link to this article: http://meritcd.com/blogs/merits-april-2014-book-giveaway/