[Federal Register Volume 84, Number 174 (Monday, September 9, 2019)]
[Notices]
[Pages 47298-47299]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-19395]


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FEDERAL TRADE COMMISSION

[File No. 182 3195]


EmpiriStat, Inc.; Analysis To Aid Public Comment

AGENCY: Federal Trade Commission.

ACTION: Proposed consent agreement; request for comment.

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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 October 9, 2019.

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: ``EmpiriStat, Inc.; 
File No. 182 3195'' 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: Robin Wetherill (202-326-2220), 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 Home Page (for September 3, 2019), on the World Wide Web, 
at 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 October 9, 2019. 
Write ``EmpiriStat, Inc.; File No. 182 3195'' 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.
    Postal mail addressed to the Commission is subject to delay due to 
heightened security screening. As a result, we encourage you to submit 
your comments online through the https://www.regulations.gov website.
    If you prefer to file your comment on paper, write ``EmpiriStat, 
Inc.; File No. 182 3195'' on your comment and on the envelope, and 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 that 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 that your 
comment does not include any 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 http://www.ftc.gov to read this Notice and 
the

[[Page 47299]]

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 October 9, 2019. 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 
EmpiriStat, Inc. (``EmpiriStat'' or ``Respondent'').
    The proposed consent order (``proposed order'') has been placed on 
the public record for thirty (30) days for receipt of comments by 
interested persons. Comments received during this period will become 
part of the public record. After thirty (30) 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 EmpiriStat made concerning its participation in and compliance 
with the Privacy Shield framework agreed upon by the U.S. and the 
European Union (``EU''). The Privacy Shield framework allows U.S. 
companies to receive personal data transferred from the EU without 
violating EU. The frameworks consist 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 frameworks, 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.
    EmpiriStat provides statistical analysis and clinical trial support 
services. According to the Commission's complaint, EmpiriStat published 
on its website, http://www.empiristat.com, 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 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. and Swiss-U.S. Privacy Shield 
frameworks. The proposed complaint further alleges that Respondent 
engaged in deceptive acts or practices by representing that it complied 
with those frameworks when in fact it had failed to comply with certain 
Privacy Shield requirements.
    Part I of the proposed order prohibits the company 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 of the proposed order requires that the company affirm to 
Commerce that it will either continue to apply the Privacy Shield 
framework principles to any data it received pursuant to frameworks or 
will delete or return such data.
    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 notification to the FTC of changes in corporate status and 
mandates that the company submit an initial compliance report to the 
FTC. Part V requires the company to create certain documents relating 
to its compliance with the order for ten (10) years and to retain those 
documents for a five-year period. Part VI mandates that the company 
make available to the FTC information or subsequent compliance reports, 
as requested.
    Part VII is a provision ``sun-setting'' the order after twenty (20) 
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. 2019-19395 Filed 9-6-19; 8:45 am]
BILLING CODE 6750-01-P