THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED AND HOW YOU CAN GET ACCESS TO THIS INFORMATION. PLEASE REVIEW IT CAREFULLY.
This notice of privacy practices (the "HIPAA Privacy Notice") describes how we may use and disclose your Medical Information to carry out treatment, payment or health care operations and for other purposes that are permitted or required by law, including by the Health Insurance Portability and Accountability Act, and all regulations issued thereunder ("HIPAA"). It also describes your rights to access and control your Medical Information. As used herein, "Medical Information" is information about you, including demographic information, that may identify you and that relates to your past, present or future physical or mental health or condition and related health care services.
Uses and Disclosures of Medical Information
We will only use and disclose your Medical Information as permitted by law. Except for disclosures outlined in this HIPAA Privacy Notice and/or permitted by law, we will obtain your written authorization before using your Medical Information or disclosing it to any outside persons or organizations. Most uses or disclosures of your Medical Information constituting psychotherapy notes will be made only after receiving your written authorization. We will not use or disclose your Medical Information for purposes of marketing, except as permitted by law and/or outlined in this HIPAA Privacy Notice. We will not sell your Medical Information, without first obtaining your written authorization. You may revoke any written authorization you have provided to us at any time, except to the extent that we have made any uses or disclosures of your Medical Information in reliance on such authorization. To revoke a previously issued authorization, please send your request in writing, along with a copy of the authorization being revoked to our Privacy Officer. If a copy of the applicable authorization is not available, please provide a detailed description and date of the same to our Privacy Officer.
There are some situations where we may use or disclose your Medical Information without your prior written authorization, as described further below:
- Uses and Disclosures of Your Medical Information Related to the Treatment and Services Provided By Us
- Treatment, Payment and Health Care Operations: We may use your Medical Information for treatment, to obtain payment for treatment, for administrative purposes, and to evaluate the quality of care that you receive without your authorization. We may use or disclose Medical Information about you without your authorization for several other reasons.
Example of Treatment: In connection with treatment, we may use your Medical Information to provide you with one of our products.
Example of Payment: We may use your Medical Information to generate a health insurance claim and to collect payment on invoices for services and/or medical devices provided.
Example of Health Care Operations: We may use your Medical Information in order to process and fulfill your orders and to provide you with customer service.
- Appointment Reminder and Other Communications: We may use or disclose your Medical Information without your prior written authorization to provide you or others with, among other things, (i) appointment reminders; (ii) product/supply reorder notifications; and/or (iii) information about treatment alternatives or other health-related products and services that we provide.
- Family, Friends and Emergencies: If you require emergency treatment and we are unable to obtain your consent, we may disclose your Medical Information to a family member or relative who is involved in your care.
- Marketing: We may use or disclose your Medical Information to provide you with marketing communications about the health-related products and services that we provide, and about products, services, treatment or healthcare providers that may be of interest to you.
Additional Categories of Uses and Disclosures:
- Required By Law: We may use or disclose your Medical Information to the extent that applicable law requires the use or disclosure of such Medical Information. Where the use and/or disclosure of Medical Information is by law, the use or disclosure will be made in compliance with the law and will be limited to the relevant requirements of the law. You will be notified, as required by law, of any such uses or disclosures.
- Public Health: We may disclose your Medical Information for public health activities and purposes to a public health authority that is permitted by law to collect or receive the information. The disclosure will be made for the purpose of preventing or controlling disease, injury or disability. We may also disclose your Medical Information, if directed by the public health authority, to a foreign government agency that is collaborating with the public health authority.
- Communicable Diseases: We may disclose your Medical Information, if authorized by law, to a person who may have been exposed to a communicable disease or may otherwise be at risk of contracting or spreading the disease or condition.
- Health Oversight: We may disclose Medical Information to a health oversight agency for activities authorized by law, such as audits, investigations, and inspections. Oversight agencies seeking this information include government agencies that oversee the healthcare system, government benefit programs, other government regulatory programs and civil rights laws.
- Food and Drug Administration: We may disclose your Medical Information to a person or company as directed or required by the Food and Drug Administration: (i) to collect or report adverse events (or similar activities with respect to food or dietary supplements), product defects or problems (including problems with the use or labeling of a product), or biological product deviations, (ii) to track FDA-regulated products, (iii) to enable product recalls, repairs or replacement, or look back (including locating and notifying individuals who have received products that have been recalled, withdrawn, or are the subject of look back), or (iv) to conduct post-marketing surveillance.
- Legal Proceedings: We may disclose your Medical Information in the course of any judicial or administrative proceeding (i) in response to an order of a court or administrative tribunal (to the extent such disclosure is expressly authorized), and (ii) in certain conditions in response to a subpoena, discovery request or other lawful process, after we receive satisfactory assurance that the party seeking the information has reasonably attempted to notify you of the request or has reasonably attempted to secure a qualified protective order (in a court or administrative tribunal, or by stipulation) to limit disclosure of your Medical Information.
- Law Enforcement: We may disclose Medical Information, as long as applicable legal requirements are met, for law enforcement purposes. These law enforcement purposes include: (i) legal processes otherwise required by law, (ii) limited information requests for identification and location purposes, (iii) pertaining to victims of a crime, (iv) suspicion that death has occurred as a result of criminal conduct, (v) in the event that a crime occurs on the premises of the practice, and (vi) medical emergency in which it is likely that a crime has occurred.
- Research: We may disclose your Medical Information to researchers when their research has been approved by an institutional review board that has reviewed the research proposal and established protocols to ensure the privacy of your Medical Information.
- Criminal Activity: Consistent with applicable federal and state laws, we may disclose your Medical Information, if we believe the use or disclosure is necessary to prevent or lessen a serious and imminent threat to the health or safety of a person or the public. We may also disclose Medical Information if it is necessary for law enforcement authorities to identify or apprehend an individual.
- Military Activity and National Security: When the appropriate conditions apply, we may use or disclose Medical Information of individuals who are Armed Forces personnel (i) for activities deemed necessary by appropriate military command authorities; , or (ii) to foreign military authority if you are a member of that foreign military service. We may also disclose your Medical Information to authorized federal officials for conducting national security and intelligence activities.
- Workers' Compensation: We may disclose your Medical Information as authorized to comply with workers' compensation laws and other similar legally-established programs.
- Inmates: We may use or disclose your Medical Information to a correctional institution or law enforcement official if you are an inmate of a correctional facility and your physician created or received your Medical Information in the course of providing care to you, and disclosure is necessary for (i) providing you with health care; (ii) the health and safety of you, other inmates, or others at the correctional institution; or (iii) the administration and maintenance of the safety, security, and good order of the correctional institution.
- Required Uses and Disclosures: Under the law, we must make disclosures to you when required by the Secretary of the Department of Health and Human Services to investigate or determine our compliance with the requirements of HIPAA.
- Non-identifiable Information: We may use or disclose your Medical Information if we have removed from it any information that is personally identifiable to you.
The following is a statement of your rights with respect to your Medical Information and a brief description of how you may exercise these rights.
You Have the Right to Inspect and Copy Your Medical Information: This means you may inspect and obtain a copy of Medical Information about you, provided, however, that applicable law may limit your ability to inspect or copy certain types of records. In certain circumstances, if we deny your request to review Medical Information, you may have a right to have this decision reviewed. If you would like to make a request to review your Medical Information, please download our Request Form and follow the directions included on that form. We will respond to your request in a reasonable amount of time. If your request is honored, we may charge a nominal fee for photocopying expenses. Please contact our Privacy Officer if you have questions about access to your Medical Information.
You May Have the Right to Amend your Medical Information: If you believe that the Medical Information we have about you is incorrect or incomplete, you may ask us to make an amendment to your Medical Information. You may request an amendment as long as the Medical Information is still maintained in our records. If you would like to make a request to review your Medical Information, please download our Request Form and follow the directions included on that form. We will respond to your request in a reasonable amount of time. Please contact our Privacy Officer if you have questions about requesting an amendment to your Medical Information.
You Have the Right to Request a Restriction of Your Medical Information: You may ask us not to use or disclose any part of your Medical Information for the purposes of treatment, payment or healthcare operations. You may also request that any part of your Medical Information not be disclosed to family members or friends who may be involved in your care or for notification purposes as described in this HIPAA Privacy Notice. Your request must state the specific restriction requested and to whom you want the restriction to apply. Except as otherwise provided in this HIPAA Privacy Notice, we are not required to agree to a restriction that you may request. We are required to agree to your request to restrict disclosure of your Medical Information to a health plan if (i) the disclosure is to carry out payment or healthcare operations and is not otherwise required by law; and (ii) your Medical Information pertains solely to a healthcare item or service for which you or someone (other than the health plan) on your behalf, has paid us in full. If we agree to the requested restriction, we may not use or disclose your Medical Information in violation of that restriction unless it is needed to provide emergency treatment. If you would like to request a restriction of the use of your Medical Information, please download our Request Form and follow the directions included on that form. We will respond to your request in a reasonable amount of time. Please contact our Privacy Officer if you have questions about requesting a restriction of the use of your Medical Information.
You Have the Right to Request to Receive Confidential Communications From Us By Alternative Means or at an Alternative Location: We will accommodate reasonable requests to receive confidential communications from us by alternate means or at an alternative location. We may also limit this accommodation by asking you for information as to how payment will be handled or specification of an alternative address or other method of contact. We will not request an explanation from you as to the basis for the request. Please make this request in writing to our Privacy Officer.
You Have the Right to Receive an Accounting of Certain Disclosures We Have Made, if any, of your Medical Information: This right applies to disclosures for purposes other than treatment, payment or healthcare operations as described in this HIPAA Privacy Notice. It excludes disclosures we may have made to you, for a facility directory, to family members or friends involved in your care, for notification purposes, for national security or intelligence purposes, to correctional institutions or law enforcement officials, or as part of a limited data set. You have the right to receive specific information regarding these disclosures that occurred after April 14, 2003, or as otherwise provided for under applicable law. You may request a shorter timeframe. The right to receive this information is subject to certain exceptions, restrictions and limitations. If you would like to request an accounting of certain disclosure of your Medical Information, please download our Request Form and follow the directions included on that form. We will respond to your request in a reasonable amount of time. Please contact our Privacy Officer if you have questions about requesting an accounting of the disclosures of your Medical Information.
You Have The Right to Obtain a Copy of this HIPAA Privacy Notice: You have the right to obtain a paper copy of this HIPAA Privacy Notice from us, upon request, even if you have agreed to accept this notice electronically. If you would like to request a paper copy of this HIPAA Privacy Notice, please download our Request Form and follow the directions included on that form.
Generally: We are required by law to maintain the privacy and security of your Medical Information and to provide you with notice of our legal duties and privacy practices with respect to Medical Information, and to notify you if there is a breach resulting in disclosure of your unsecured Medical Information.
Revisions and Modifications: We may change this HIPAA Privacy Notice at any time. Before we make a significant change in our policies, we will change this HIPAA Privacy Notice and post our new notice (the "Revised HIPAA Privacy Notice"). We are required to abide by the terms of this HIPAA Privacy Notice until a Revised HIPAA Privacy Notice becomes effective. The Revised HIPAA Privacy Notice will be effective for all Medical Information that we maintain as of the effective date of the Revised HIPAA Privacy Notice even if we collected or received the Medical Information prior to the effective date of the Revised HIPAA Privacy Notice. The current HIPAA Privacy Notice is posted on our Website at www.MyOmnipod.com If you would like to request a paper copy of this HIPAA Privacy Notice, please download our Request Form and follow the directions included on that form.
What To Do If You Have a Problem or Question. If you have any further questions relating to this HIPAA Privacy Notice or if you have a problem or complaint, please contact us in writing or by phone at:
Attn: Judy Preston, Privacy Officer
Billerica, MA 01821
Furthermore, if you believe that Insulet has violated your privacy rights with respect to your Medical Information, you have the right to file a complaint in writing with our Privacy Officer or with the Secretary of Health and Human Services at 200 Independence Avenue, S.W. Washington, D.C. 20201 or by calling (877) 696-6775. Insulet will not retaliate against you for filing such a complaint.
Effective Date: August 11, 2004
Revision Date: April 1, 2009, September 20, 2013, April 22, 2014 and September 2, 2014.