COPYRIGHT AND INTENDED USE STATEMENT
Copyright©2007 Sysmex America Inc, Mundelein, Illinois, USA.
The information, documents and related graphics published in this Internet site ("Information") are the sole property of Sysmex America Inc. Permission to use the Information is granted, provided that use of Information is for informational and non-commercial or personal use only.
All product names are trademarks owned by or licensed to Sysmex Corporation, its subsidiaries or affiliates. No use of any Sysmex trademark, trade names, trade dress and products in this Internet site may be made without prior written authorization of Sysmex America Inc, except to identify the product or services of the company.
By accessing and using this website, or by downloading materials from this website, you agree to abide by all terms and conditions of use set forth below. If you do not agree to these terms and conditions of use, do not access or use this website, and do not access or download materials from it.
This website may be used for informational purposes only, except with respect to password protected and/or secure areas.
Sysmex America, Inc. is a wholly-owned subsidiary of Sysmex Corporation, Kobe, Japan. This website, including all of its contents, is copyrighted material, owned or controlled by Sysmex America, Inc. and/or Sysmex Corporation, and it contains SYSMEX AMERICA, INC.’s and/or Sysmex Corporation’s name, trademarks, service marks, trade names, and other intellectual property. SYSMEX AMERICA, INC. authorizes you to view the contents of this website solely for your use in learning about, evaluating or obtaining Sysmex’s products or services. You may download the materials on this website to a single computer and print one copy of the material, provided that such copy shall retain all copyright and other proprietary notices contained thereon. This permission is not a transfer of title to the materials, and no other rights are granted to you to download, upload, store, copy, print, reproduce, alter, modify, transmit, distribute, or publicly display the materials on the website or under any copyright, trademark, service mark, trade name or other Sysmex Corporation’s or SYSMEX AMERICA, INC.’s intellectual property.
DISCLAIMER AND NO WARRANTY
Each person assumes full responsibility and all risks arising from use of this Internet site. The Information is presented "AS IS" and may include unintentional technical inaccuracies or typographical errors. Sysmex America Inc. reserves the right to make additions, deletions, or modifications to the Information at any time without any prior notification.
Sysmex America Inc. makes no representations or warranties of any kind or nature with respect to the information. Sysmex America Inc. hereby disclaims all representations and warranties, whether expressed or implied, created by law, contract or otherwise, including without limitation, any warranties of merchantability, fitness for a particular purpose, title or non-infringement.
In no event shall Sysmex Corporation of America, its parent company, Sysmex Corporation or any other Sysmex office or subsidiary be liable for any damages of any kind or nature, including, without limitation, direct, indirect, special (including loss of profit) consequential or incidental damages arising from or in connection with the existence or use of this Internet site and/or the information, regardless of whether or not Sysmex America Inc. has been advised as to the possibility of such damages.
Sysmex America Inc. provides access to Sysmex Corporation international data and therefore, may contain references or cross references to Sysmex Corporation products, programs and services that are not announced in the user’s country. Such reference does not imply that Sysmex Corporation or Sysmex America Inc. intends to announce such products, programs and services in the user’s country. All actions resulting from a search of this data must be related to solutions using only products, programs and services announced by Sysmex Corporation in the user’s country.
Customer testimonials contain end-user responses that reflect individual customer experiences and may refer to practices specifically developed by customers for use in their own laboratories. Some customized applications may not reflect practices described in the North American version of the Operator’s Manual for various products. Customized applications may require validation by the laboratory in order to conform to specific governing regulations.
LINKING AND THIRD-PARTY SITES
You are not permitted to hyperlink to SYSMEX AMERICA, INC.’s or Sysmex Corporation’s icons, website address or any page in SYSMEX AMERICA, INC.'s website without express written consent of an SYSMEX AMERICA, INC. corporate officer or designee. SYSMEX AMERICA, INC. is also not responsible for any hyperlinks to its icons, website or any page in the website. SYSMEX AMERICA, INC.'s website, which may from time to time provide links to websites operated and maintained by others. SYSMEX AMERICA, INC. makes no representation or warranty regarding the accuracy, timeliness, suitability or any other aspect of the information located on such websites and neither monitors nor endorses such websites or the contents. Any links to other websites are merely provided as a convenience to the user of this site.
Links to the websites of any third parties are posted on the Sysmex America Inc. website for convenience only. We therefore do not express any opinion on the content of any third parties’ websites and expressly disclaim any liability for all third party information and the use of it.
ACCESS TO PASSWORD PROTECTED PAGES
Access to and use of areas of the SYSMEX AMERICA, INC. website requiring a password is restricted to authorized users only. Unauthorized persons attempting to access these areas may be subject to prosecution.
RIGHT TO CHANGE SITE
SYSMEX AMERICA, INC. may modify, add, rename, change or improve its website and the contents thereof, including the terms and conditions of your use of this site. Your continued use of this website after such changes are made will be considered acceptance of those changes.
SYSMEX AMERICA, INC. encourages you to provide feedback on how to improve the SYSMEX AMERICA, INC. website. Any comments may be e-mailed to email@example.com. Any feedback shall be deemed to be non-confidential and you agree that SYSMEX AMERICA, INC. may use such information in any way it chooses. Any rights to materials and ideas submitted to us become SYSMEX AMERICA, INC.’s exclusive property. You agree that any information provided to SYSMEX AMERICA, INC. shall not contain defamatory, offensive, threatening, obscene, harassing, infringing or otherwise unlawful material or proprietary material of another. SYSMEX AMERICA, INC. shall not be liable for such material and reserves the right to remove it from the website without liability.
By visiting http://www.sysmex.com/ and http://www.sysmex.co.jp/en/ir/index.html you are accepting the practices described in this Privacy Notice.
SYSMEX AMERICA, INC. respects your privacy and is sensitive to privacy issues on the Internet. SYSMEX AMERICA, INC. uses your identifying information for enhancing your experience on our website and to send you communications that may be of interest to you. SYSMEX AMERICA, INC. may make identifying information available to reputable third-parties whose products or services we think you may find interesting. SYSMEX AMERICA, INC. may use such information to contact people for marketing purposes.
In addition, access to certain of SYSMEX AMERICA, INC.'s web pages requires a login and password. The use of these pages may also be governed by a written agreement between you and SYSMEX AMERICA, INC. Your identifying information used on these pages may be retained by SYSMEX AMERICA, INC. to verify compliance with the agreement, process an order or allow you to access specific account information. SYSMEX AMERICA, INC. takes reasonable steps to protect the identifying information that you provide to us.
Finally, SYSMEX AMERICA, INC. may from time to time use a technology called cookies in order to track the web pages you have visited. If you prefer, you can set your browser to warn you before accepting cookies, or you can also refuse all cookies by turning them off in your browser. Doing so will not effect your ability to access SYSMEX AMERICA, INC.'s website.
This website may contain certain statements relating to future results of SYSMEX AMERICA, INC., which are forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on beliefs of SYSMEX AMERICA, INC. management as well as assumptions and estimates based on information currently available to SYSMEX AMERICA, INC., and are subject to certain risks and uncertainties that could cause actual results to differ materially from historical results or those anticipated, depending on a variety of factors, including: implementation of information technology systems, integration of acquisitions, marketplace competition, unidentified Year 2000 problems, economic and aviation/aerospace market stability and SYSMEX AMERICA, INC. profitability. Should one or more of these risks or uncertainties materialize adversely, or should underlying assumptions or estimates prove incorrect, actual results may vary materially from those described.
Health Insurance Portability and Accountability Act of 1996 (“HIPAA”), 45 CFR parts 160, 162 and 164. Notice of Privacy Practices for Personal Health Information and Business Associate Agreements.
This Notice addresses Health Insurance Portability and Accountability Act of 1996 Privacy Regulations 45 CFR part 160, 162 and 164, Business Associate Agreement. Sysmex America, Inc. (“SAI”) frequently receives requests to execute a "business associate" agreement pursuant to certain provisions of the Health Insurance Portability and Accountability Act of 1996 ("HIPAA").
1. In General
The business associate requirements applicable for the HIPAA Privacy Rule exclude nonconsensual disclosures by a covered entity to a medical device company representative (medical device company). See 45 CFR 164.506(c) (1). Additionally, when the medical device company is a health care provider as defined by the rule, any covered health care provider (or other covered entity) may share protected health information with a medical device company without a business associate contract. Furthermore, the HIPAA Security Rule adopts the Privacy Rule definition of a “business associate”.
Based on our existing relationship with our customers and other applicable institutions, and our review of the HIPAA Regulations and Guidance available from the Department of Health and Human Services (“HHS”). We have determined that SAI is not a "business associate" as that term is defined under HIPAA, and Business Associate Agreement is precluded. The term ‘‘covered entity’’ is defined at 45 CFR 160.103 and includes health plans, health care clearinghouses, and health care providers who conduct certain health care transactions electronically. A fourth type of covered entity, prescription drug card sponsors, was added by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003 (Pub. L. 108–173).
SAI acknowledges that our customers and certain other applicable institutions are considered “covered entities" as that term is defined under HIPAA and, as such, must take certain actions to ensure the confidentiality of “protected health information” (PHI) stored or transmitted “electronic protected health information (ePHI).
As a medical device company, SAI representatives may have limited, incidental access to PHI and ePHI while engaged in activities or other purposes related to the quality, safety, or effectiveness of the FDA regulated product. In corroboration with our current regulatory compliance strategies, we have in place written policies. HIPAA Compliance Policy, Security Policy for Confidentiality and appropriate training for all associates, as well as any additional training required for their specific roles. In addition, periodic assessments of associate training records ensure that associates have attended the required training. Review of these training records as well as verification that procedures are in place for support of this notice are reviewed as part of SAI’s’ internal audit process.
No SAI associate, agent or consultant should engage in any activity that may inappropriately use or disclose patient information. Inappropriate use or disclosure of patient information is defined by SAI and includes any action taken that is outside of SAI representative’s specific role or is not necessary in order to perform their job duties. Accordingly, SAI agrees that it shall not willfully attempt to gain unauthorized access, use,disclosure, modification, or destruction of information or interference with PHI, and no SAI
associate, agent or consultant shall attempt to gain unauthorized access, use, disclosure, modification, or destruction of information or interference with any “PHI", as that term is defined under HIPAA, through SAI's provision of products or services to our customers and certain other applicable institutions.
III. Data in Transit
SAI provides implementation and support services for a variety of healthcare institutions. SAI supports the requirement to protect patient privacy. In addition, SAI may also provide enhanced support services such as remote system monitoring and remote access, in which we may act as the custodian of the ePHI for certain clients. With remote system monitoring and remote access, the highest degree of endpoint security is achieved by placing the instrument in a “restricted mode” where no protected health information can be incidentally viewed during the remote access session. In the case of “data in transit”, Health Level Seven (“HL7”) interfaces transactional processing of electronic data; the disclosure of ePHI is intended by the healthcare organization/covered entity to the recipient. As such, the healthcare organization/covered entity must comply with 45 CFR 164.314a requiring the covered entity to “ obtain “ and document
satisfactory assurance that the business associate or non-business associate will appropriately safeguard the information, through a written contract or “other arrangement” with the business associate or non-business associate that meets the applicable requirements of the 45 CFR 164.314(a).
In the event, SAI associates, agents or contractors do gain limited or incidental access to PHI while engaged in activities or other permissible purposes related to the quality, safety, or effectiveness of the FDA regulated product, SAI agrees to undertake reasonable efforts not to disclose any PHI for any purpose whatsoever other than expressly required by law or which may be permitted by another agreement. SAI further agrees to undertake reasonable efforts to comply with all federal and state laws, rules and regulations regarding confidentiality of patient health information as they apply to SAI, including but not limited to, provisions of HIPAA.
V. Changes to This Notice
We reserve the right to change the terms of this notice at any time. The effective date of this notice and any revised or changed notice may be found on the last page, on the bottom right hand corner of the notice.
For additional information regarding SAI HIPAA policies or our general privacy and confidentiality policies, please contact Peter Osella, Vice President- Regulatory Affairs/Quality Systems (847-996-4512) or Kelshall Pierre, HIPAA Compliance Officer (847-996-4523).