scholarly journals Sales, Acquisitions, and Mergers of Direct-to-Consumer Genetic Testing Companies

2021 ◽  
Vol 8 (2) ◽  
pp. 403-421
Author(s):  
Alyssa K. McLeod
Keyword(s):  
United States ◽  
Genetic Testing ◽  
Personal Information ◽  
Personal Data ◽  
The United States ◽  
Genetic Tests ◽  
Direct To Consumer ◽  
Testing Company ◽  
Privacy Risks ◽  
A Company

Direct-to-consumer genetic tests have become increasingly popular in the United States within the last few years. However, these tests pose many risks to the consumer, most notably privacy risks. A subset of these privacy risks involves the issue of company mergers, acquisitions, and sales. Many companies in the direct-to-consumer genetic testing market have privacy policies that contain a variation of a “business transfer” clause. These clauses specify that in the event the company goes through a business transition such as a sale, merger, or acquisition, the consumer’s personal information—including the consumer’s DNA—will be among the assets transferred. This Article explores the risks associated with these business transfer clauses as they relate to the consumer, and presents a solution to mitigate said risks. The solution lies in FTC v. Toysmart, wherein a toy company that filed for bankruptcy was restricted in selling its assets—which included its customers’ personal data— only to entities with the same interests as the toy company. This Article urges that the default interpretation standard of business transfer clauses track similarly such that a direct-to-consumer genetic testing company may only be sold to, merged with, or acquired by a company with the same or like interests.

scholarly journals Public attitudes towards algorithmic personalization and use of personal data online: evidence from Germany, Great Britain, and the United States

2021 ◽  
Vol 8 (1) ◽  
Author(s):  
Anastasia Kozyreva ◽  
Philipp Lorenz-Spreen ◽  
Ralph Hertwig ◽  
Stephan Lewandowsky ◽  
Stefan M. Herzog
Keyword(s):  
United States ◽  
Great Britain ◽  
Data Privacy ◽  
Large Scale ◽  
Personal Information ◽  
Public Attitudes ◽  
Personal Data ◽  
The United States ◽  
Individual Level ◽  
Personalized Services

AbstractPeople rely on data-driven AI technologies nearly every time they go online, whether they are shopping, scrolling through news feeds, or looking for entertainment. Yet despite their ubiquity, personalization algorithms and the associated large-scale collection of personal data have largely escaped public scrutiny. Policy makers who wish to introduce regulations that respect people’s attitudes towards privacy and algorithmic personalization on the Internet would greatly benefit from knowing how people perceive personalization and personal data collection. To contribute to an empirical foundation for this knowledge, we surveyed public attitudes towards key aspects of algorithmic personalization and people’s data privacy concerns and behavior using representative online samples in Germany (N = 1065), Great Britain (N = 1092), and the United States (N = 1059). Our findings show that people object to the collection and use of sensitive personal information and to the personalization of political campaigning and, in Germany and Great Britain, to the personalization of news sources. Encouragingly, attitudes are independent of political preferences: People across the political spectrum share the same concerns about their data privacy and show similar levels of acceptance regarding personalized digital services and the use of private data for personalization. We also found an acceptability gap: People are more accepting of personalized services than of the collection of personal data and information required for these services. A large majority of respondents rated, on average, personalized services as more acceptable than the collection of personal information or data. The acceptability gap can be observed at both the aggregate and the individual level. Across countries, between 64% and 75% of respondents showed an acceptability gap. Our findings suggest a need for transparent algorithmic personalization that minimizes use of personal data, respects people’s preferences on personalization, is easy to adjust, and does not extend to political advertising.

scholarly journals Bioconstitutional Imaginaries and the Comparative Politics of Genetic Self-knowledge

2020 ◽  
Vol 45 (6) ◽  
pp. 1087-1118
Author(s):  
J. Benjamin Hurlbut ◽  
Ingrid Metzler ◽  
Luca Marelli ◽  
Sheila Jasanoff
Keyword(s):  
United States ◽  
United Kingdom ◽  
Genetic Testing ◽  
Comparative Politics ◽  
Well Being ◽  
The United States ◽  
Direct To Consumer ◽  
The United Kingdom ◽  
Before And After ◽  
Self Knowledge

Genetic testing has become a vehicle through which basic constitutional relationships between citizens and the state are revisited, reaffirmed, or rearticulated. The interplay between the is of genetic knowledge and the ought of government unfolds in the context of diverse imaginaries of the forms of human well-being, freedom, and flourishing that states have a duty to support. This article examines how the United Kingdom, Germany, and the United States governed testing for Alzheimer’s disease, and how they diverged in defining potential harms, benefits, and objects of regulation. Comparison before and after the arrival of direct-to-consumer genetic tests reveals differences in national understandings of what it means to protect life and citizenship: in the United Kingdom, ensuring physical wellness through clinical utility; in the United States, protecting both citizens’ physical well-being and freedom to choose through a framework of consumer protection; and in Germany, emphasizing individual flourishing and an unburdened sense of human development that is expressed in genetic testing law and policy as a commitment to the stewardship of personhood. Operating with their own visions of what it means to protect life and citizenship, these three states arrived at settlements that coproduced substantially different bioconstitutional regimes around Alzheimer’s testing.

scholarly journals ASHG Statement* on Direct-to-Consumer Genetic Testing in the United States

2007 ◽  
Vol 81 (3) ◽  
pp. 635-637 ◽  
Author(s):  
Kathy Hudson ◽  
Gail Javitt ◽  
Wylie Burke ◽  
Peter Byers
Keyword(s):  
United States ◽  
Genetic Testing ◽  
The United States ◽  
Direct To Consumer

ASHG Statement* on Direct-to-Consumer Genetic Testing in the United States

2007 ◽  
Vol 110 (6) ◽  
pp. 1392-1395 ◽  
Author(s):  
Kathy Hudson ◽  
Gail Javitt ◽  
Wylie Burke ◽  
Peter Byers
Keyword(s):  
United States ◽  
Genetic Testing ◽  
The United States ◽  
Direct To Consumer

scholarly journals Promoting Safe and Effective Genetic Tests in the United States: Work of the Task Force on Genetic Testing

1999 ◽  
Vol 45 (5) ◽  
pp. 732-738 ◽  
Author(s):  
Neil A Holtzman
Keyword(s):  
United States ◽  
Genetic Testing ◽  
Human Services ◽  
Task Force ◽  
Healthcare Providers ◽  
The United States ◽  
Appropriate Use ◽  
Genetic Tests ◽  
Health And Human Services ◽  
Other Information

Abstract The Task Force on Genetic Testing was created to review genetic testing in the United States and, when necessary, to make recommendations to ensure the development of safe and effective genetic tests. A survey to explore the state of genetic testing was undertaken for the Task Force and completed in early 1995. The survey, as well as literature reports and other information collected for the Task Force, showed problems affecting safety and effectiveness, as defined by the Task Force: validity and utility of predictive tests, laboratory quality, and appropriate use by healthcare providers and consumers. On the basis of these findings, the Task Force made several recommendations to ensure safe and effective genetic testing. The Secretary of Health and Human Services followed up one recommendation by creating the Secretary’s Advisory Committee on Genetic Testing. One of its functions will be to implement other recommendations of the Task Force.

Marketing Genetic Tests: Empowerment or Snake Oil?

2005 ◽  
Vol 32 (5) ◽  
pp. 676-685 ◽  
Author(s):  
Deborah J. Bowen ◽  
Kathryn M. Battuello ◽  
Monique Raats
Keyword(s):  
United States ◽  
Genetic Testing ◽  
Public Education ◽  
General Public ◽  
The United States ◽  
Genetic Tests ◽  
Accurate Knowledge

Genetic tests are currently being offered to the general public with little oversight and regulation as to which tests are allowed to be sold clinically and little control over the marketing and promotion of sales and use. This article provides discussion and data to indicate that the general public holds high opinions of genetic testing and that current media outlets for public education on genetic testing are not adequate to increase accurate knowledge of genetics. The authors argue that more regulation is needed to control and correct this problem in the United States.

scholarly journals Innovative Commercial and Private Genetic Testing Raises Privacy and Confidentiality Concerns

2018 ◽  
pp. 31-33
Author(s):  
Syeda Masooma Zaidi
Keyword(s):  
Genetic Testing ◽  
Personal Information ◽  
Personal Data ◽  
Third Party ◽  
Sensitive Information ◽  
Test Results ◽  
Direct To Consumer ◽  
Client Data ◽  
The Right ◽  
Privacy And Confidentiality

Obtaining information about your genes can be as easy as swabbing your cheek for DNA testing. Companies that offer direct-to-consumer genetic testing with saliva have the authority to collect and share personal data as well as test results from their clients. However, patients want their personal information to be protected and although these companies ask for consent before sharing information with third-party sources, companies have the right to use client data to initiate research or improve their business. Genetic testing companies need to respect their clients and understand that they are paying for a service which deals with sensitive information that individuals may not want collected and stored.

Review of form 483s and warning letters to pharmaceutical manufacturers issued by USFDA

2021 ◽  
pp. 174113432110235
Author(s):  
Chandan Saini ◽  
Ashish Miglani ◽  
Pankaj Musyuni ◽  
Geeta Aggarwal
Keyword(s):  
Public Health ◽  
United States ◽  
Regulatory Authority ◽  
The United States ◽  
Federal Law ◽  
Pharmaceutical Manufacturers ◽  
The World ◽  
Considerable Impact ◽  
A Company ◽  
Responsible Person

Regular inspections are carried out to ensure system conformity by the Food and Drugs Regulatory Authority (FDA) of the United States one of the most stringent regulatory authorities in the world. The inspectors send Form 483 to the management after the inspection, detailing the inappropriate conditions. Because the FDA guidelines are difficult to comply with, a company can contravene the regulations. If any significant infringements can affect the protection, quality, effectiveness, or public health of the drug is identified, the FDA issues advice to the company. Warning Letters (WL) shall be an official notification of non-compliance with federal law within a period to be issued by manufacturer, clinician, distributor, or responsible person in the company. The delivery of a letter has a considerable impact on the company's reputation and position in the market. Inadequate WL reactions could lead to a refusal, import denial, memorandum or even conviction and order. A brief study was conducted in this document of Form 483 and WL for four years (2017–2020) on an understanding the regulatory provisions.

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