Privacy Shield

AWS Partnership

Precision Digital Health, Incorporated (PDH), a United States business complies with the EU-US Privacy Shield Framework and Swiss-US Privacy Shield Framework as set forth by the U.S. Department of Commerce regarding the collection, use and retention of Personal Data from European Union member countries and Switzerland.  PDH shall adhere to the Privacy Shield Principles of Notice; Choice; Accountability for Onward Transfer; Security; Data Integrity and Purpose Limitation, Access and Recourse; Enforcement, and Liability.  If there are any conflicts between the policies in Precision Digital Health, Incorporated (PDH), Privacy Shield Policy (“Privacy Shield Policy”) and the Privacy Shield Principles, the Privacy Shield Principles shall govern.  To learn more about the Privacy Shield program please visit https://www.privacyshield.gov/.   

Precision Digital Health, Incorporated (PDH), a United States business provides a platform service in support of clinical research globally. PDH leverages real-world data from various data sources; such as, electronic health records, device data from both medical devices and wearables from our client’s data subjects, Pharmaceutical and Health Care organizations.

Our Clients are pharmaceutical/biotech companies, medical device companies and various other types of clinical research organizations.  PDH is required to comply with the United States Federal Drug and Administration (FDA) rules and regulations as well as other regulatory bodies based on the nature of the work.

Precision Digital Health, Incorporated (PDH), a United States business shall comply with the EU-US Privacy Shield Framework and Swiss-US Privacy Shield Framework as set forth by the U.S. Department of Commerce regarding the collection, use and retention of Personal Data from European Union member countries, the United Kingdom, and Switzerland transferred to the United States pursuant to Privacy Shield.  PDH has certified that it adheres to the Privacy Shield Principles with respect to such data. If there is any conflict between the policies in this privacy policy and data subject rights under the Privacy Shield Principles, the Privacy Shield Principles shall govern. To learn more about the Privacy Shield program, and to view our certification page, please visit https://www.privacyshield.gov/   

Definitions

Data Subject – The individual to whom any given Personal Data covered by this Privacy Shield Policy refers.

Personal Data – Information relating to an individual residing in the European Union, the United Kingdom, and Switzerland that can be used to identify that individual either on its own or in combination with other readily available data.

Sensitive Personal Data – Personal Data regarding an individual’s racial or ethnic origin, political opinions, religious or philosophical beliefs, physical or mental health, or sexual life. 

Scope and Responsibilities

Precision Digital Health, Incorporated (PDH) Privacy Shield applies to Personal Data transferred from European Union members countries, the United Kingdom, and Switzerland to PDH’s operations in the U.S. in trust on the respective Privacy Shield framework and does not apply to Personal Data transferred under Standard Contractual Clauses or any approved derogation from the EU Directive.

Some types of Personal Data may be subject to other privacy-related requirements and policies.  For example,

  • Personal Data regarding and/or received from a client is also subject to any specific agreement with, or notice to, the client, as well as additional applicable laws and professional standards.
  • Precision Digital Health, Inc.,  Standard Operating Procedures (SOPs) and any additional Corporate Policies that targets Data Protection, Data Security and Data Integrity.

All designated employees of PDH have access in the U.S. to Personal Data covered by this Privacy Shield Policy are responsible for conducting themselves in accordance with this Privacy Shield Policy.

PDH reserves the right to disclose all information collected to the extent required by law or to respond to judicial process. 

Privacy Shield Principles 

Notice

We notify our, customers,  and others located in the EEA, the UK, and Switzerland about the purposes for which we collect and use Personal Data, the types of third parties to which we disclose the information, clients and vendors have for limiting the use and disclosure of their information, and how to contact us about our practices concerning Personal Data. 

Purpose of Collection and Use of Personal Data

PDH collects certain Personal Data such as name, email address, and telephone number. We do not collect sensitive Personal Data of , customers or  third-party vendor, such as information about medical or health conditions, racial or ethnic origin, political opinions, religious or philosophical beliefs, trade union membership or other sensitive information as defined by the Privacy Shield framework.

  • as agent / data processor for the purpose to host it on behalf of business partners / customers and/or to provide clinical research services, consulting services, clinical research support activities, and statistical analysis of clinical studies on pharmaceutical products and/or regulatory affairs services and services to business partners / customers based on agreements executed between business partners / customers and PDH.

We use Personal Data of clients,  third-party vendors and others (i) to respond to their requests, (ii) to evaluate the quality of our products and services, (iii) to communicate with them about our products, services and related issues, and (iv) to comply with our legal obligations, policies and procedures.

Precision Digital Health’s (PDH) understands client’s relationship with their providers, clients, officers and employees is confidential.  During the period of agreement, PDH may receive, or may have already received, knowledge of, or access to, information which relates to the business, operations, products, or plans of PDH or of its clients and which is not known to the general public (hereinafter “Confidential Information”).  PDH will not at any time, without the express prior written consent of an authorized representative of PDH: (a) use the client data, personal data, and provider data for any purpose, (b) disclose any Confidential Information to any other person or entity, or (c) use any Confidential Information for PDH’s own benefit or the benefit of any other person or entity.  PDH shall only disclose Confidential Information to those of its employees who have a need to know the information in connection with PDH’s provision of Services.  Promptly upon the request of client or the termination of an Agreement with the client, PDH shall return to or destroy as directed by client, all Confidential Information in its possession. 

Choice

If Personal Data covered by this Privacy Shield Policy is to be used for a new purpose that is materially different for which the Personal Data was originally collected or subsequently authorized, or is to be disclosed to a non-agent third party, PDH will ensure any individual, data subject,  with an opportunity to choose whether to have their Personal Data to be used or disclosed. Requests to opt out of such uses or disclosures of Personal Data should be sent to: datasecurity@precisiondigitalhealth.com

If Sensitive Personal Data covered by this Privacy Shield Policy is to be used for a new purpose that is different from that for which the Personal Data was originally collected or subsequently authorized, or is to be disclosed to a third-party vendor, PDH will obtain the Data Subject’s explicit consent prior to such use or disclosure. 

Onward Transfer of Personal Data

We  only share Personal Data with our direct clients and  client approved third-party vendors that  have been retained contractually to perform services on their r behalf. We now require clients  to whom we disclose Personal Data and who are not subject to laws based on the EU’s General Data Protection Regulation, the UK’s Data Protection Act 2018, or the Swiss Federal Act on Data Protection, as applicable, to either (i) subscribe to the Privacy Shield principles or (ii) contractually agree to provide at least the same level of protection for Personal Data as is required by the relevant Privacy Shield principles. If any  party does not comply with its privacy obligations, PDH will take commercially reasonable steps to prevent or stop the use or disclosure of Personal Data. In the context of an onward transfer, PDH has responsibility for the processing of personal information it receives under the Privacy Shield and subsequently transfers to a third party acting as an agent on its behalf. PDH shall remain liable under the Principles if its agents that it engages to process such personal information do so in a manner inconsistent with the Principles, unless PDH proves that it is not responsible for the event giving rise to the damage.

Security

PDH takes reasonable and appropriate measures to protect Personal Data covered by this Privacy Shield Policy from loss, misuse, and unauthorized access, disclosure, alteration, and destruction, taking into due account the risks involved in the processing and the nature of the Personal Data. 

Data Integrity

PDH takes reasonable steps to ensure that Personal Data collected by PDH is relevant for the purposes for which it is to be used and that the information is reliable for its intended use and is accurate, complete and current.  

Your Rights to Access, to Limit Use, and to Limit Disclosure

Pursuant to the Privacy Shield Frameworks, EU, UK, and Swiss individuals have the right to obtain our confirmation of whether we maintain personal information relating to you in the United States. Upon request, we will provide you with access to the personal information that we hold about you. You may also correct, amend, or delete the personal information we hold about you. An individual who seeks access, or who seeks to correct, amend, or delete inaccurate data transferred to the United States under Privacy Shield, should direct their query to datasecurity@precisiondigitalhealth.com If requested to remove data, we will respond within a reasonable timeframe.

Compelled Disclosure

PDH may be required to disclose personal information received from EEA member countries and Switzerland in reliance on the Privacy Shield in response to lawful requests by U.S. public authorities, including to meet national security or law enforcement requirements.

Inquiries and Complaints

In compliance with the Privacy Shield Principles, PDH, commits to resolve complaints about your privacy and our collection or use of your personal information transferred to the United States pursuant to Privacy Shield. European Union, the United Kingdom, and Swiss individuals with Privacy Shield inquiries or complaints should first contact PDH by email at datasecurity@precisiondigitalhealth.com.

PDH has further committed to refer unresolved privacy complaints under the Privacy Shield Principles to an independent dispute resolution mechanism, the BBB EU PRIVACY SHIELD.  If you do not receive timely acknowledgment of your complaint, or if your complaint is not satisfactorily addressed, please visit http://www.bbb.org/EU-privacy-shield/for-eu-consumers for more information and to file a complaint. This service is provided free of charge to you. If your Privacy Shield complaint cannot be resolved through the above channels, under certain conditions, you may invoke binding arbitration for some residual claims not resolved by other redress mechanisms. See Privacy Shield Annex 1 at https://www.privacyshield.gov/article?id=ANNEX-I-introduction.

How to Contact Us

You may address any questions or concerns regarding our Privacy Shield Policy or our practices concerning Personal Data by:

Contacting us through our website: https://precisiondigitalhealth.com or

Writing to:
Precision Digital Health, Incorporated
Attention: Thomas Wells, CEO
15615 Alton Parkway
Irvine, CA  92618
USA 

U.S. Federal Trade Commission Enforcement

PDH’s participation in the EU-U.S. Privacy Shield Framework and the Swiss-U.S. Privacy Shield Framework is subject to investigation and enforcement by the Federal Trade Commission. 

Amendment

Designated employees of PDH have access in the U.S. to Personal Data covered by this Privacy Shield Policy are responsible for conducting themselves in accordance with this Privacy Shield Policy.

PDH reserves the right to disclose all information collected to the extent required by law or to respond to judicial process.

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