Ortho-Clinical Diagnostics, Inc.; Analysis of Proposed Consent Order To Aid Public Comment, 19481-19483 [2020-07311]

Agencies

• FEDERAL TRADE COMMISSION

[Federal Register Volume 85, Number 67 (Tuesday, April 7, 2020)]
[Notices]
[Pages 19481-19483]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-07311]


-----------------------------------------------------------------------

FEDERAL TRADE COMMISSION

[File No. 192 3050]


Ortho-Clinical Diagnostics, Inc.; Analysis of Proposed Consent 
Order To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed Consent Agreement; request for comment.

-----------------------------------------------------------------------

SUMMARY: The consent agreement in this matter settles alleged 
violations of federal law prohibiting unfair or deceptive acts or 
practices. The attached Analysis to Aid Public Comment describes both 
the allegations in the complaint and the terms of the consent order--
embodied in the consent agreement--that would settle these allegations.

DATES: Comments must be received on or before May 7, 2020.

ADDRESSES: Interested parties may file comments online or on paper, by 
following the instructions in the Request for Comment part of the 
SUPPLEMENTARY INFORMATION section below. Write ``Ortho-Clinical 
Diagnostics, Inc.; File No. 192 3050'' on your comment, and file your 
comment online at https://www.regulations.gov by following the 
instructions on the web-based form. If you prefer to file your comment 
on paper, mail your comment to the following address: Federal Trade 
Commission, Office of the Secretary, 600 Pennsylvania Avenue NW, Suite 
CC-5610 (Annex D), Washington, DC 20580, or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex 
D), Washington, DC 20024.

FOR FURTHER INFORMATION CONTACT: Kenneth Abbe (310-824-4300), Bureau of 
Consumer Protection, Federal Trade Commission, 600 Pennsylvania Avenue 
NW, Washington, DC 20580.

SUPPLEMENTARY INFORMATION: Pursuant to Section 6(f) of the Federal 
Trade Commission Act, 15 U.S.C. 46(f), and FTC Rule 2.34, 16 CFR 2.34, 
notice is hereby given that the above-captioned consent agreement 
containing a consent order to cease and desist, having been filed with 
and accepted, subject to final approval, by the Commission, has been 
placed on the public record for a period of thirty (30) days. The 
following Analysis to Aid Public Comment describes the terms of the 
consent agreement and the allegations in the complaint. An electronic 
copy of the full text of the consent agreement package can be obtained 
from the FTC website (for March 30, 2020), at this web address: https://www.ftc.gov/news-events/commission-actions.
    You can file a comment online or on paper. For the Commission to 
consider your comment, we must receive it on or before May 7, 2020. 
Write ``Ortho-Clinical Diagnostics, Inc.; File No. 192 3050'' on your 
comment. Your comment--including your name and your state--will be 
placed on the public record of this proceeding, including, to the 
extent practicable, on the https://www.regulations.gov website.
    Due to the public health emergency in response to the COVID-19 
outbreak and the agency's heightened security screening, postal mail 
addressed to the Commission will be subject to delay. We strongly 
encourage you to submit your comments online through the https://www.regulations.gov website.
    If you prefer to file your comment on paper, write ``Ortho-Clinical 
Diagnostics, Inc.; File No. 192 3050'' on your comment and on the 
envelope, and

[[Page 19482]]

mail your comment to the following address: Federal Trade Commission, 
Office of the Secretary, 600 Pennsylvania Avenue NW, Suite CC-5610 
(Annex D), Washington, DC 20580; or deliver your comment to the 
following address: Federal Trade Commission, Office of the Secretary, 
Constitution Center, 400 7th Street SW, 5th Floor, Suite 5610 (Annex 
D), Washington, DC 20024. If possible, submit your paper comment to the 
Commission by courier or overnight service.
    Because your comment will be placed on the publicly accessible 
website at https://www.regulations.gov, you are solely responsible for 
making sure your comment does not include any sensitive or confidential 
information. In particular, your comment should not include any 
sensitive personal information, such as your or anyone else's Social 
Security number; date of birth; driver's license number or other state 
identification number, or foreign country equivalent; passport number; 
financial account number; or credit or debit card number. You are also 
solely responsible for making sure your comment does not include 
sensitive health information, such as medical records or other 
individually identifiable health information. In addition, your comment 
should not include any ``trade secret or any commercial or financial 
information which . . . is privileged or confidential''--as provided by 
Section 6(f) of the FTC Act, 15 U.S.C. 46(f), and FTC Rule 4.10(a)(2), 
16 CFR 4.10(a)(2)--including in particular competitively sensitive 
information such as costs, sales statistics, inventories, formulas, 
patterns, devices, manufacturing processes, or customer names.
    Comments containing material for which confidential treatment is 
requested must be filed in paper form, must be clearly labeled 
``Confidential,'' and must comply with FTC Rule 4.9(c). In particular, 
the written request for confidential treatment that accompanies the 
comment must include the factual and legal basis for the request, and 
must identify the specific portions of the comment to be withheld from 
the public record. See FTC Rule 4.9(c). Your comment will be kept 
confidential only if the General Counsel grants your request in 
accordance with the law and the public interest. Once your comment has 
been posted on the public FTC website--as legally required by FTC Rule 
4.9(b)--we cannot redact or remove your comment from the FTC website, 
unless you submit a confidentiality request that meets the requirements 
for such treatment under FTC Rule 4.9(c), and the General Counsel 
grants that request.
    Visit the FTC website at https://www.ftc.gov to read this Notice and 
the news release describing it. The FTC Act and other laws that the 
Commission administers permit the collection of public comments to 
consider and use in this proceeding, as appropriate. The Commission 
will consider all timely and responsive public comments that it 
receives on or before May 7, 2020. For information on the Commission's 
privacy policy, including routine uses permitted by the Privacy Act, 
see https://www.ftc.gov/site-information/privacy-policy.

Analysis of Proposed Consent Order To Aid Public Comment

    The Federal Trade Commission (``Commission'') has accepted, subject 
to final approval, an agreement containing a consent order from Ortho-
Clinical Diagnostics, Inc. (``Ortho'' or ``Respondent'').
    The proposed consent order (``proposed order'') has been placed on 
the public record for thirty days for receipt of comments by interested 
persons. Comments received during this period will become part of the 
public record. After thirty days, the Commission will again review the 
agreement and the comments received, and will decide whether it should 
withdraw from the agreement and take appropriate action or make final 
the agreement's proposed order.
    This matter concerns alleged false or misleading representations 
that Ortho made concerning its participation in the Privacy Shield 
framework agreed upon by the U.S. and the European Union (``EU''). The 
Privacy Shield framework allows for the lawful transfer of personal 
data from the EU to participating companies. The framework consists of 
a set of principles and related requirements that have been deemed by 
the European Commission as providing ``adequate'' privacy protection. 
The principles include notice; choice; accountability for onward 
transfer; security; data integrity and purpose limitation; access; and 
recourse, enforcement, and liability. The related requirements include, 
for example, securing an independent recourse mechanism to handle any 
disputes about how the company handles information about EU citizens.
    To participate in the framework, a company must comply with the 
Privacy Shield principles and self-certify that compliance to the U.S. 
Department of Commerce (``Commerce''). Commerce reviews companies' 
self-certification applications and maintains a public website, https://www.privacyshield.gov/list, where it posts the names of companies who 
have completed the requirements for certification. Companies are 
required to recertify every year in order to continue benefitting from 
Privacy Shield.
    Ortho markets and sells medical devices and in vitro diagnostics 
services to the global clinical laboratory and immunohematology 
communities. It collects personal data from its suppliers and capital 
customers around the world, including from EU citizens. According to 
the Commission's complaint, from approximately September 2017 until 
March 2019, Ortho published on its website, https://www.orthoclinicaldiagnostics.com/en-us/home/privacy-policy, a privacy 
policy containing statements related to its participation in Privacy 
Shield.
    The Commission's proposed three-count complaint alleges that 
Respondent violated Section 5(a) of the Federal Trade Commission Act. 
Specifically, the first count in the proposed complaint alleges that 
Respondent engaged in a deceptive act or practice by falsely 
representing that it was a certified participant in the EU-U.S. Privacy 
Shield Framework. The second count alleges that Ortho did not verify 
the truth of the Privacy Shield assurances in its privacy policy, 
either through a self-assessment or a third party compliance review, so 
its representation that it ``complied with'' the Privacy Shield 
principles was false. Finally, the third count alleges that Ortho 
failed to annually affirm to Commerce that Ortho will continue to apply 
the Privacy Shield Principles to personal data it received while it was 
part of the framework after it withdraws from Privacy Shield.
    Part I of the proposed order prohibits the Respondent from making 
misrepresentations about its membership in any privacy or security 
program sponsored by the government or any other self-regulatory or 
standard-setting organization, including, but not limited to, the EU-
U.S. Privacy Shield framework and the Swiss-U.S. Privacy Shield 
framework. Part II also specifically requires the Respondent to comply 
with the Privacy Shield requirement to continue to protect personal 
information received while in the framework.
    Parts III through VI of the proposed order are reporting and 
compliance provisions. Part III requires acknowledgement of the order 
and dissemination of the order now and in the future to persons with 
responsibilities relating to the subject matter of the order. Part IV 
ensures

[[Page 19483]]

notification to the FTC of changes in corporate status and mandates 
that the Respondent submit an initial compliance report to the FTC. 
Part V requires the Respondent to create certain documents relating to 
its compliance with the order for ten years and to retain those 
documents for a five-year period. Part VI mandates that the Respondent 
make available to the FTC information or subsequent compliance reports, 
as requested.
    Part VII is a provision ``sun-setting'' the order after twenty 
years, with certain exceptions.
    The purpose of this analysis is to aid public comment on the 
proposed order. It is not intended to constitute an official 
interpretation of the complaint or proposed order, or to modify in any 
way the proposed order's terms.

    By direction of the Commission.
April J. Tabor,
Acting Secretary.
[FR Doc. 2020-07311 Filed 4-6-20; 8:45 am]
 BILLING CODE 6750-01-P