Terms & Conditions and Privacy Policy

Effective 1 April 2015

The following terms and conditions constitute an agreement between you and the UK Teratology Information Service (UKTIS), the operator of bumps – best use of medicines in pregnancy, www.medicinesinpregnancy.org (the “Site”). This agreement governs your use of the Site, both as a casual visitor or user and as a registered member as described below.

By accessing or using the Site you agree to be bound by the terms of this Agreement. If you register on the Site as a member, then in addition to the terms that are applicable to all users of the Site, the terms that apply to members shall apply to you too.

Medical Information on bumps 
Every effort is taken to ensure that information on this website produced by UKTIS is accurate, complete and up-to-date at the time of writing, but no guarantee is made to that effect. The absence of a warning for a given drug or drug combination does not guarantee that the drug or drug combination is safe, effective, or the most appropriate therapy for a particular patient. Information compiled by UKTIS is for use by healthcare practitioners and/or members of the public in the UK. UKTIS does not warrant that use outside of the United Kingdom is appropriate.

bumps does not provide individual patient medical advice. The information on bumps (and/or UKTIS.org) is generic and cannot address all the issues that may be important for individual women, and is therefore not a substitute for professional medical advice or treatment. The advice of your doctor or another qualified healthcare professional must be sought before you make any decisions relating to use of a medicine or treatment, either before or during pregnancy. Never disregard or delay seeking professional medical advice on the basis of information or material on this Site. If you have a medical emergency, seek medical advice through the NHS (UK residents) or equivalent emergency service in your country of residence immediately.

Materials provided on the Site by Users and Members do not represent advice or recommendations from UKTIS and are for the purpose of user discussion and information exchange only. Such materials include written text, treatment regimes, outcomes, charts, patient profiles, graphics, photographs, images, advice, messages, forum postings, and information in any other form. UKTIS does not recommend or endorse any particular tests, health care professionals, products, procedures, or opinions, and other information on the Site that has not been produced by UKTIS. Reliance on any information provided by UKTIS, by other members of bumps, or by persons invited by UKTIS to contribute to the Site is solely at your own risk.

Membership Eligibility
To join bumps (become a member) and access the area on this Site reserved for members (the “Member Area”), UKTIS requires that you are either (a) pregnant, (b) the parent or legal guardian acting for a pregnant individual who is incapacitated, or (c) a parent who would like to provide information about your previous pregnancies and outcomes.

Children under the age of 13 are prohibited from registering as members. By registering as a member you represent that you are age 13 or older.

Acceptable and Lawful Use of Site by Members
All members represent and warrant that the information they provided when registering as a member, and all information that they subsequently provide regarding themselves and their membership, is true and accurate and not misleading.

Members shall not post or upload any information or other content on the Site that (a) is false, inaccurate or misleading, (b) is obscene or indecent, (c) infringes any copyright, patent, trademark, trade secret or other proprietary rights or rights of publicity or privacy of any party, or (d) is defamatory, libelous, threatening, abusive, hateful, or contains pornography. Members shall not interfere with other members’ use and enjoyment of the Site (for example, by harassing, threatening, soliciting, overly promoting personal interests, or stalking another participant of a chat room, forum, seminar, or threaded message, including the use of expressions of bigotry, racism, hatred, or profanity). Members may not use the Site to conduct any activity that is illegal or violates the rights of others, provide instructional information about illegal activities, or promote physical harm or injury against any group or individual.

Interference with Operation of Site is not permitted
You may not interfere or attempt to interfere with the Site through the use of a robot, spider, scraper, or other automated means to access the Site, Site content or services provided on the Site for any purposes. You may not post content on the Site that contains any viruses, Trojan horses, worms, time bombs, spiders, or other computer programming routines that are intended to damage, interfere with, surreptitiously intercept or expropriate any system, data or personal information. You shall not attempt to make the Site unavailable through denial-of-service attacks or similar means. You shall not use contact information provided by members, or collect information about our members, to facilitate the sending of unsolicited bulk communications such as SPAM or SPIM, or allow others use of your membership account to take such actions.

bumps is for Non-Commercial Use Only
The Site content, including the Member Area and the content and information contained in the Member Area, is for the personal use of individual members only and may not be used in connection with any commercial endeavors. Organisations, companies, and/or businesses may not become members and should not use the Site without express consent from UKTIS. Members of bumps with individual commercial interests may not solicit or overtly promote their products or services within the Member Area. All content shared within the Site is not for external use. To garner permission and access to members, please submit all media and analyst inquiries and all research requests to UKTIS in writing.

Privacy Policy
By using the Site you confirm that you have read, understood and accept the Privacy Policy, which covers how personal and non-personal information collected from you when you use the Site is used and shared.

Posting and Use of Content in the Member Area
The Member Area is likely to include community areas such as forums and member area, in the future that you as a member will have access to and may post messages, images and other content (“User Submissions”). If you are a member, you (or the author) own the copyright in the messages, images and other content you post in the Member Area, but by posting such content within User Submissions to the Member Area you grant UKTIS and our affiliates the right to use, copy, display, perform, distribute, translate, edit, and create derivative works of your User Submissions, subject to the terms of the Privacy Policy.

Community areas in the Member Area may be monitored periodically for topicality, however, UKTIS has no obligation to prescreen postings and is not responsible for the content of such postings. We would be grateful if members would notify us of inappropriate or illegal content. UKTIS reserve the right to remove postings for any reason and without explanation.

You agree not to disclose to any person or entity personally identifiable information that has been posted in the Member Area by a member, or emailed to you by a member, about other members using this Site without the express consent of the identified member. You may only disclose information of a general nature (that could not identify the member who provided such information or whom such information is about) to third parties outside this Site.

Member Password and Login Identity
You are responsible for maintaining the confidentiality of your member password and login, and are fully responsible for all activities that occur under your password or account with or without your knowledge. If you knowingly provide your login and password information to another person your membership privileges may be temporarily suspended or terminated. You agree to notify UKTIS via the online UKTIS feedback form of any unauthorized use of your membership password or login or any other breach of security.

Links to Other Websites
The Site may contain links to other websites that are not under the control of UKTIS. The inclusion of any link does not imply endorsement by UKTIS of such sites and UKTIS is not responsible for the content of such linked sites.

Membership Termination
You agree that UKTIS may, with or without cause, immediately terminate your bumps membership, or limit or terminate your access to the Member Area or the Site without prior notice. Without limiting the foregoing, the following may lead to a termination by UKTIS of a member's membership and use of the Site: (a) breaches or violations of this Agreement or other incorporated agreements or guidelines, (b) requests by law enforcement or other government agencies, (c) a request by you (self-initiated membership cancellation), (d) unexpected technical issues or problems, and (e) extended periods of inactivity. UKTIS has no obligation to maintain, store, or transfer to you information or data that you have posted on or uploaded to the Site.

Modifications to this Agreement
We reserve the right to modify this Agreement at any time, and without prior notice, by posting amended terms on this Site. We encourage you to review this Agreement periodically for any updates or changes, which will have an update effective date.

Fees
bumps membership is free.

Disclaimer of Warranties
The Site and the content and services made available on the Site are provided on an “as is” and “as available” basis. UKTIS does not make, and disclaims all express and implied warranties and representations, including but not limited to, any implied warranty of fitness for a particular purpose with regard to the Site, the Site content, or any advice or services provided through the Site to the extent permitted by law. UKTIS does not warrant that access to the Site or its content or services will be uninterrupted or error-free or that defects in the Site will be corrected.

The advice, recommendations, information, and conclusions posted or emailed by other members of the Site are not in any way vetted, approved or endorsed by UKTIS, and use of such information is at your own risk.

Limitation of Liability
Under no circumstances shall UKTIS, its partners, contributors, agents, employees, directors or affiliates be liable for any indirect, incidental, special, or consequential damages (even if it has been advised of the possibility of such damages) due to your use of this Site or due to your reliance on any of the content contained or the services provided on the Site.

Indemnification
You agree to indemnify and hold harmless, UKTIS, its officers, employees, agents, subsidiaries, affiliates and other partners from and against any claims, actions or demands, liabilities and settlements, including without limitation, reasonable legal and accounting fees resulting, or alleged to result from, your violation of this Agreement.

International Users
UKTIS makes no claims that information on the Site is appropriate for use outside of the United Kingdom. Personal information (“Information”) that is submitted to this Site will be collected, processed, stored, disclosed and disposed of in accordance with applicable UK law and the Privacy Policy. If you are a non-UK user you acknowledge and agree that UKTIS may collect and use your Information and disclose it to other entities outside your resident jurisdiction. In addition, such Information may be stored on servers located outside your resident jurisdiction. UK law may not provide the degree of protection for Information that is available in other countries. By providing us with your Information you acknowledge that you consent to the transfer of such information outside your resident jurisdiction as detailed in the Privacy Policy. If you do not consent to such transfer, you may not use this Site.

Member Notices
If you register as a member you agree that UKTIS/bumps may send notices to you by email at the email address you provide when registering to become a member (or which you later update using the functionality of the Site).

Miscellaneous Terms
You agree not to display or use bumps and UKTIS logos in any manner without UKTIS' prior written permission.

UKTIS may assign this agreement at any time to a subsidiary or parent organisation as part of a merger or sale of substantially all of its assets. You may not assign or transfer this agreement.

If any provision of this Agreement is held to be unenforceable for any reason, the remaining provisions will be unaffected and remain in full force and effect.

Please report violations of this agreement via the online UKTIS feedback form.

History of Updates/Changes to Terms and Conditions of Use:

• 02 April 2015, original version (V1) of this Agreement was added to the Site.

Privacy Policy

Effective 1 April 2015

bumps – best use of medicines in pregnancy (www.medicinesinpregnancy.org  ) (“the Site”) has been developed to improve both the provision and the collection of information to support best use of medicines in pregnancy. 

This Privacy Policy outlines the type of information UKTIS collects from individuals who have registered to join bumps (“Members”), how it is used and how it may be shared with other third parties, including but not limited to, research institutions, regulatory agencies, government departments and others (“Partners”).

Data Sharing
Individual member data will not be shared with pharmaceutical companies and not-for-profit organisations that are not involved in public health surveillance (for the purpose of this agreement termed “End-users”) unless express consent to do so has been provided by a member of bumps. End-users may purchase reports with aggregated data or scientific analyses of data collected through bumps from PHE or another intermediary academic or government organisation but will have no scientific input into such reports or any direct financial arrangement with UKTIS. Where possible, an agreement will be formalised prospectively whereby UKTIS, alone or as part of a wider network such as ENTIS (the European Network of Teratology Information Services), has responsibility for the independent collection and analysis of pregnancy exposure data for a particular product e.g. to meet a regulatory requirement of marketing a product, and information relating to this arrangement will be openly available on the Site.

In addition to collecting medical and lifestyle details (“general medical information”) that are necessary for us to scientifically assess whether a medicine may be harmful to a baby in the womb when used by the mother before or during pregnancy, we offer women the opportunity to provide personal details (“identifiers”).

Shared Data
“General medical information” that Members provide about themselves through their bumps record, and other areas of the Site may be shared with UKTIS Partners for the purpose of  addressing a scientific question that is of public health relevance or related to medication safety. This information may be included in UKTIS documents or reports. Shared data will not include “identifiers” details such as a member’s name, date of birth, address, email address or password.

Examples of the format in which general medical information that Members submit to the Site, including through their bumps record, may be shared:

• As a summary report e.g. 10 bumps members used medicine xx between the 4th and 12th week of pregnancy. One baby had a cleft palate, the remaining 9 had no birth defects
• As an aggregated survey response or as a direct quote (with names or any identifiers removed)
• Direct quotes regarding feedback about the Site
• Information posted  to open areas of the Site and via social media 
In the course of using the Site, Members may share information that could be used to reasonably identify them (“Personal Information”), including name, photograph and email address. When a Member chooses to share Personal Information, photo or image via a non-restricted access (open) field (e.g. forum, feeds), the information shall be treated as Shared Data.

Restricted Data
”Identifier” information that Members (relating to themselves or their child/children) enter into designated fields when registering to use or using the Site will not be shared (“Restricted Data”).

The type of Restricted Data that Members may submit at a Restricted area of the Site may include:

• Name, when collected as part of registration or within the designated fields of Member’s bumps record
• Email address, as collected and verified as part of registration or in a Member’s Account Information
• Password, as collected as part of registration or in a Member’s Account Information
• Mailing address, as collected via email, forms, or private message
• Date of birth
• Private messages

When a Member enters Personal Information, including month and year of birth and email address, as part of registering to use a bumps record, that Personal Information is treated as Restricted Data. However, if “Identifier” data is entered elsewhere on the Site (e.g. in a forum discussion) it will be visible and accessible to all Users of the Site who have access to that area.

In situations where there is a public health benefit to combining information provided via the Site with that held in other healthcare databases, “identifiers” of members will be used to enable information from different sources to be combined. This will be done by separating “identifiers” from the medical details so that a Trusted Third Party can create a new identifier that enables records to be linked without the individuals name or other “identifiers” being part of the final complete information record.

Cookies
A cookie is a small data file that often includes an anonymous, unique token, which is sent to your browser from a website’s computers and may be stored on your computer’s hard drive. Two types of cookies are required to use the Site:

• Session Cookies are temporary cookies that remain only until you log out of the website or exit your web browser. Session Cookies do not store any Personal Information, only a unique visitor ID number that may be used to ensure Members are properly authenticated and can view Site information.
• Persistent Cookies remain in the cookie file of your browser for much longer, even after you leave the Site. Persistent Cookies also do not store any Personal Information. Persistent Cookies store preferences that should persist from visit to visit, like “Remember Me,” and a unique token to enable us to understand how Members use the Site (“Site Usage”).

How the information you provide to bumps is used
All information submitted to bumps may be stored, reviewed and analysed by UKTIS for the purpose of improving outcomes for pregnant women and their babies in the future. Reports of these analyses may be published in scientific journals, via the Site (bumps) and/or in other UKTIS documents, so that as many people as possible can benefit from the information collected via bumps. Whilst no restricted (“identifier”) data will be published, and every effort will be made to present data as an aggregated report so as to limit the details of individual cases, where a member has a very rare condition or provides very specific details about themselves, other individuals who know that member may recognise and therefore be able to identify that member. Members should be aware of this possibility when providing information to bumps.

Individual member data provided to bumps (UKTIS) will not be shared or ‘sold’ as such to commercial organisations and pharmaceutical companies (End-users). However, pharmaceutical companies are often required to set up a pregnancy registry to collect information about the first e.g. 200 hundred babies born to women who became pregnant whilst taking a newly licensed medicine (for which human pregnancy safety data are not available). In the past, pharmaceutical companies collected this information themselves. This is no longer encouraged and it is recognised that pregnancy registries and studies are best conducted by groups who are completely independent of the company who sell the product and who have experience in studying and analysing information relating to medicine use in pregnancy (such as teratologists).

UKTIS may therefore be asked by an academic or public body third party to hold a registry for a new medicine and may collect this information through bumps. The pharmaceutical company or other End-user will not have access to an individual member’s information and will have no say in how the data is scientifically analysed or prevent the results from being made publically available. Interim reports/analyses that the pharmaceutical company marketing the drug is legally required to submit to the regulatory agencies may also be produced independently by UKTIS. The additional work undertaken by UKTIS will be carefully costed by the University (or other academic or public body third party) who has contracted with the pharmaceutical company.

Where surveillance through setting up a registry is not agreed prospectively, End-users may also purchase a UKTIS report of aggregated data through an academic or public body third party (e.g. that provides information about the number of women who have joined bumps and were taking a particular medicine, the average age of these women, the percentage of these pregnancies that ended in miscarriage or live birth, and whether this is higher or lower than for women not taking that medicine). All the scientific analysis in such reports will be conducted independently by UKTIS and UKTIS Partners who will have no direct financial arrangement with the End-user. Fees charged to End-users will be to cover the costs to UKTIS of the data collection and/or analysis.

Restricted data will not be shared with commercial companies.

Both Shared Data and Restricted Data, including Personal Information (identifiers), may be used and disclosed in specific situations, including but not limited to, the following:

• Internal use by UKTIS of bumps Shared Data, Restricted Data, and Site Usage for research, maintenance and operation of the Site, and to create the best possible tools and functionality for members
• UKTIS may use a Member’s data in the case of an emergency or other circumstance that we determine requires a member of the management team to directly contact the Member
• UKTIS may share or disclose a Member’s data where required by law or to comply with legal process
• In the event UKTIS goes through a business transition, such as a merger, acquisition by another organisation, or sale of all or a portion of its assets, the Shared Data and Restricted Data, including Personal Information, might be among the assets transferred. Members will be notified via this Site of any such change in ownership or control of Personal Information

Provision of data and participation in surveys hosted by bumps is voluntary and the decision not to participate or to provide further data will in no way impact a Member’s experience on the Site.

UKTIS may report individual adverse event and drug safety information collected through bumps to the MHRA and/or other UK or international regulatory bodies, such as the European Medicines Agency (EMA), and may need to provide Restricted Data where a formalised arrangement is in place, to enable identification of cases which have been reported to different sources and may otherwise falsely trigger concern regarding a serious adverse effect of an exposure.

In certain cases, government or regulatory agencies or other Partners may request that UKTIS contact Members of bumps for follow-up, and UKTIS therefore reserves the right to do so.

Areas of bumps are public forums, and Members acknowledge and accept that any information, including Personal Information, that they enter (as text or images) in an open area of bumps or a bumps social media account or forum may be shared or displayed for others.

How Restricted Data is Used
Restricted Data is never shared with ‘End-users’. It may be shared with UKTIS Partners under strict regulations and where the necessary ethical and information governance arrangements have been put in place. Examples may include use of a patient identifier to (a) identify whether a patient with an unusual or concerning event has been reported to more than one surveillance system, or (b) to enable collection of more detailed information where information collected through bumps may have implications for the wider public.

Data validity and security 
UKTIS cannot guarantee the identity of any other Members with whom a Member may interact in the course of using the Site or who may have access to a Member’s Shared Data. Additionally, we cannot guarantee the authenticity of any data that Members may provide about themselves.

Data collection via bumps will be in accordance with the Data Protection Act 1998. Precautions will be taken to minimise the risk of disclosure of personal information by implementing appropriate data protection arrangements such as password controlled access to the database in which information from bumps is stored.

Risks and benefits
While our goal is to help to improve the health outcomes of pregnant women and the unborn child, there are no certain benefits to using this website.

Providing and sharing information online caries a number of recognised risks. Whilst UKTIS will take the necessary steps to keep any information you have provided secure, it is possible that a Member could be identified using information shared on bumps (and/or in conjunction with other data sources). A Member could potentially be discriminated against or experience repercussions as a result of the information they choose to share in a discussion forum. For example, it is possible that employers, insurance companies or others may discriminate based on health information. UKTIS will not share information collected through bumps with employers of a member or with insurance companies.

If you have access to the Personal Information of a Site participant it is your responsibility to protect the privacy of that person.

In using the Site, Members may leave unanswered any questions or data fields that are not required or to stop providing information at any time. If a Member chooses to ‘close’ his/her account, previously entered data will remain in the database.

UKTIS reserve the right to modify this policy at any time, and without prior notice, by posting an amended Privacy Policy and terms on this website. We encourage Members to review this policy periodically for any updates.

History of Updates/Changes to Terms and Conditions of Use:

• On Apr 01, 2015, additional examples of shared data were added.

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