Every day people go online to get information about a medical condition or symptom, fill a prescription, get an insurance quote, participate in a chat room, or fill out a health assessment.\u00a0 All of these activities involve the exchange of information with or without the consent of the individual, and with or without their knowledge.\u00a0 For users concerned about protecting their privacy, where <\/i>they go (i.e.<\/i>, what sites they visit) will determine whether there are enforceable rules about how their health information is protected.\u00a0 More often than not, however, users will be getting health information and services from Web sites that are not covered at all by the new federal health privacy regulation.\u00a0 Here are some examples of Web sites that are not covered.<\/p>\n\nSites Providing General Health Information<\/h3>\n\n
Some of the most popular health Web sites are information-based.\u00a0 In other words, they provide people with information about general fitness and nutrition (e.g.<\/i>, www.foodfit.com), medical conditions (e.g.<\/i>, www.drkoop.com), and treatment options (e.g.<\/i>, www.medigenesis.com).\u00a0 Some offer a broad range of information, while others specialize in a certain drug or medical condition.\u00a0 They do not have an offline existence where they engage in covered activities like treating patients.\u00a0 They only furnish health information \u2013 they do not provide \u201chealth care,\u201d as it is defined in the federal regulation.[49.numoffset=”49″ Privacy Rule, \u00a7 160.103, available at http:\/\/www.hhs.gov\/ocr\/regtext.html<\/a>.]<\/p>\n\n Some sites offer additional services that require users to provide personal information to the site.\u00a0 Many Web sites offer a \u201chealth assessment\u201d feature where users may enter all sorts of information from height and weight to drug and alcohol use.\u00a0 The personal health information that consumers provide to many of these sites (e.g.<\/i>, through self-screening questionnaires or registration for e-mail reminders) will not be protected by the privacy regulation.\u00a0 For example, HealthStatus.com offers free general health assessments as well as disease specific assessments to determine an individual\u2019s risk for some of the leading causes of death.[50. http:\/\/www.healthstatus.com\/assessments.html<\/a>.] Does this constitute health care?\u00a0 HealthStatus.com\u2019s disclaimer makes clear its belief that the site does \u201cnot provide medical advice or treatment.\u201d[51. http:\/\/www.healthstatus.com\/disclaimer.html<\/a>.]\u00a0 It is not so clear that HHS would agree with this assertion.\u00a0 However, because HealthStatus.com does not accept any insurance it will not be covered by the privacy rule.<\/p>\n\n Prozac.com, a Web site owned by the drug company Eli Lilly and Co., provides information about depression.\u00a0 Until recently, individuals could sign up for an Internet service that would send them e-mail reminders about taking their medication.\u00a0 Eli Lilly and Co. is not a covered entity so health information consumers provide to prozac.com is not protected by the privacy regulation.[52. Because pharmaceutical companies do not sell or distribute drugs pursuant to prescription (unlike drug stores) they do not provide health care and are not covered by the privacy rule. See Privacy Rule, \u00a7 160.103 (defining \u201chealth care\u201d), available at http:\/\/www.hhs.gov\/ocr\/regtext.html<\/a>.] The key is that the e-mail reminder originates from someone who is not covered by the privacy rule.\u00a0 If, in contrast, a covered physician sent a patient an e-mail reminder that it was time for her annual mammogram, the e-mail would be covered by the privacy rule.<\/p>\n\n Users also may give Web sites personal information when they provide an e-mail address to obtain more information about a certain health topic.\u00a0 For example, users can receive free diet and nutrition-related information from eDiets.com by entering their e-mail address at the site.\u00a0 This information would not be covered by the privacy rule.<\/p>\n\n A user might participate in a chat room where her e-mail address is used as well.\u00a0 Or, a site may have banner advertisers that collect information without users ever knowing.\u00a0 Many of these sites track users through cookies.[53. Cookies are small text files a Web site places on a computer\u2019s hard drive so the site can collect information about a person\u2019s visit.]\u00a0\u00a0Cookie files allow a Web site to know when a user has visited a site and each page the user visits to create online user profiles.\u00a0 User profiles help sites determine what information, products and services are used by the visitors.\u00a0 They also allow sites to deliver specific content to users based on their previous online activities.\u00a0 Although cookies are only numbers assigned by a site to each user, personal data can be linked to the number when an individual provides identifiable information to the site (e.g.<\/i>, completing health assessments).\u00a0 A 1999 study of health-related Web sites found, however, that profiling is not generally disclosed or explained to visitors of a site.[54. Goldman et al., supra<\/em> note 10.] The end result is that the Web site owner \u2013 and possibly third parties \u2013 has a great deal of health-related information that can be attached to a particular person without the person\u2019s knowledge or consent.\u00a0 But the sites are bound by nothing more than their own privacy policies. <\/p>\n\n The press has been filled with stories about rogue Web sites selling drugs without a legitimate prescription.[55.numoffset=”55″ See e.g.<\/em>, A. Fawcett, \u201cOnline Rx,\u201d Atlanta J. & Const.<\/em>, Aug. 7, 2001, at 1C; R.J. Ignelzi, \u201cRisky prescription; Online drug buyers gamble with more than their credit cards,\u201d The San Diego Union-Trib.<\/em>, Aug. 6, 2001, at E1; G. Wheelwright, \u201cInevitable marketplace for lifestyle drug: Online Viagra Sales,\u201d Fin. Times<\/em>, Feb. 21, 2001, at 11. S. Coburn, \u201cA Web Bazaar Turns Into a Pharmaceutical Free-for-All,\u201d N.Y. Times<\/em>, Oct. 25, 2000, at H20; J.A. Karash, \u201cMore prescriptions are being filled on the Net. It\u2019s buyer beware when getting medications online,\u201d Kan. City Star<\/em>, Oct. 22, 2000, at G1.] Many of these \u201cpharmacists\u201d only do business online.\u00a0 They specialize in drugs that treat sensitive or embarrassing conditions \u2013 like Viagra for impotence[56. See, e.g.<\/em>, http:\/\/www.at-home-viagra.com<\/a>.<\/p>\n\n 57<\/sup><\/a> See, e.g.<\/em>, http:\/\/www.propeciapharmacy.com<\/a>.] and Propecia for hair-loss[57. See, e.g.<\/em>, http:\/\/www.propeciapharmacy.com<\/a>.] \u2013 that a patient may not ask for from his doctor.\u00a0 There also are sites that provide online prescriptions for products that are not always easy to obtain, like the \u201cmorning after\u201d pill.[58. See, e.g.<\/em>, http:\/\/www.virtualmedicalgroup.com<\/a>.]\u00a0 The recent public scare of biological warfare prompted by the September 11 attacks has popularized Web sites that offer Cipro, an antibiotic used to treat bacterial infections, including anthrax.[59. See, e.g.<\/em>, http:\/\/www.2-buy-cipro-online-4-anthrax-bacteria-resistance.com<\/a>; see Julie Appleby, \u201cWeb sites market antibiotic to treat anthrax,\u201d USA Today<\/em>, Oct. 11, 2001, at 1B.]<\/p>\n\n The sites allow people to purchase a drug if they fill out a health assessment.\u00a0 The transaction may include a fee for an online \u201cconsultation\u201d with a doctor.\u00a0 Most importantly, however, the sites require payment for the entire transaction via credit card.\u00a0 They do not accept health insurance.\u00a0 It is important to note that the distinguishing factor here is not that the information is being obtained online, but that the pharmacist never processes health claims information in standard format, and therefore, is not a \u201ccovered entity\u201d under the regulation.\u00a0 By refusing insurance, these sites remain outside the scope of the federal privacy regulation.<\/p>\n\n The vigilant patient might better protect her privacy by filling her prescription at a site that takes insurance \u2013 such as CVS.com or drugstore.com.\u00a0 Here, even if a person pays out-of-pocket, her information will be protected by the regulation.\u00a0 <\/p>\n\n Web sites that sell only non-prescription health products, such as healthandbeautydepot.com, also fall outside the scope of the privacy regulation \u2013 they are not covered entities.\u00a0 The sale of non-prescription health products is not considered \u201chealth care,\u201d whether it takes place online or at a local drugstore.\u00a0 Hence, identifiable health information disclosed when purchasing over-the-counter allergy medicine, for example, is not protected health information.<\/p>\n\n Some Web sites provide health care but still<\/i> are not covered by the regulation.\u00a0 Why?\u00a0 They do not accept health insurance.\u00a0 Only providers that process health claims electronically in a standard format are covered by the regulation.\u00a0 What does this mean for consumers?\u00a0 Simple activities like filling a prescription online may not be covered by the regulation.\u00a0 <\/p>\n\n Another example is online counseling.\u00a0 Some Web sites now allow users to participate in a therapy session online.\u00a0 These sites also tend to be \u201ccredit card only.\u201d\u00a0 Here2listen.com[60.numoffset=”60″ http:\/\/www.here2listen.com<\/a>.] and cyberanalysis.com[61. http:\/\/www.cyberanalysis.com<\/a>.] are examples of Web sites that offer online consultations.\u00a0 <\/p>\n\n At here2listen.com, individuals can select a participating therapist from the here2listen.com database to conduct sessions online based on the counselor\u2019s education, geographic location or fee level.\u00a0 The site accepts credit cards as payment for the counseling service.\u00a0 Insurance is not accepted through the Web site.\u00a0 This site appears to be acting as a referral service for the counselors.\u00a0 For some counselors, it appears that the online counseling is an extension of their offline practice.\u00a0 Although the counselors on this site are clearly \u201chealth care providers,\u201d it is unclear whether they are required to comply with the regulation.\u00a0 A health care provider must meet specific criteria to be covered by HIPAA.\u00a0 Do they ever accept health insurance (such as in their offline practice)?\u00a0 If so, do they process claims information electronically?\u00a0 Is the information transmitted in the required standard format?\u00a0 If the counselors transmit health claims type data electronically in standard format, they are covered entities and the privacy regulation would apply to their online counseling activities.\u00a0 The Web site itself would be a business associate, since it receives health information on behalf of the covered providers.<\/p>\n\n Cyberanalysis.com presents a slightly different format for online counseling services.\u00a0 At cyberanalysis.com, patients can make arrangements to communicate with participating doctors by cyber chat, e-mail, videophone or telephone.\u00a0 An important point about this Web site is that it is not <\/i>a referral service but is actually a virtual counseling center that has analysts on staff.\u00a0 Thus, the critical question here is whether the Web site itself is a covered entity.\u00a0 Since it does not accept health insurance, the site and the counseling that takes place on the site, would not be covered by the privacy rule. <\/p>\n\n In both of these instances, a person\u2019s desire for anonymity may ironically leave her more vulnerable to exposure.\u00a0 It is important to note that while consumers often lie, withhold information, or mask their identity on the Web to maintain anonymity, in these examples, they may be forced to identify themselves.\u00a0 To get the service, an individual will be required to provide her name, credit card number and a mailing address.<\/p>\n\n Another type of online health service that consumers may consider health care is clinical trial recruitment.\u00a0 At ClinicalTrials.com,[62. http:\/\/www.clinicaltrials.com<\/a>.] individuals can register for e-mail updates about clinical trials and learn about current trials by providing their name and address and selecting the medical condition(s) of interest.\u00a0 ClinicalTrials.com falls outside the scope of the privacy regulation \u2013 it is neither a covered entity nor a business associate.\u00a0 <\/p>\n\n AmericasDoctor[63. http:\/\/www.americasdoctor.com<\/a>.] engages in slightly different activities \u2013 it offers information about clinical trials and recruits patients for its own investigative sites as well as non-AmericasDoctor trial sites.\u00a0 AmericasDoctor is not a covered entity because it is not engaged in providing health care so the health information collected on its Web site would not be protected by the regulation.\u00a0 It is not obvious from the site, however, whether or not AmericasDoctor might be considered a business associate when it assists non-AmericasDoctor study sites with patient recruitment.\u00a0 If the Web site is recruiting patients for a covered entity engaged in clinical research, it might be a business associate and, therefore, identifiable health information collected by the site with respect to that trial would be protected by the regulation under a business associate contract.\u00a0 If the physicians or hospitals are not covered entities, then the privacy regulation\u2019s restrictions on use and disclosure will not apply to AmericasDoctor. <\/p>\n\n Many hope that online health care puts patients in the driver\u2019s seat by giving them access to more information, and indeed many Web sites do give patients more information.\u00a0 Some even offer health management tools like online medical records.\u00a0 But sites that are exclusively<\/i> controlled by patients are not covered by the new privacy regulation.\u00a0 Individuals may unknowingly make \u201cprotected health information\u201d un<\/i>protected when they take information from their doctor and give it to a Web site.\u00a0 For example, sites where the patient acts as the intermediary between providers may not be covered.\u00a0 <\/p>\n\n Consider the following two examples: online second opinions and online medical records.\u00a0 Online second opinions allow patients to obtain expert medical advice in the comfort of their homes.\u00a0 Cancer patients, for example, can release their medical records to MDExpert.com,[64.numoffset=”64″ http:\/\/www.mdexpert.com<\/a>.] which has a network of over 200 cancer experts who offer second opinions after reviewing the medical records.\u00a0 The expert dictates or e-mails her opinion to MDExpert, where it is reviewed by MDExpert\u2019s medical director and a consulting physician.\u00a0 The opinion is then compiled into a report with clinical trials information, reference information and patient education materials and is sent to the primary physician for review and discussion with his or her patient.\u00a0 A second opinion from MDExpert.com is payable only by credit card, which suggests that the site is not a covered entity, and therefore that its online activities do not fall within the scope of the privacy regulation.<\/p>\n\n There are also sites that allow consumers to create their own medical records online.\u00a0 For example, PersonalMD.com[65. http:\/\/www.personalmd.com<\/a>.] enables patients to manage all of their medical information on one site, which the patient can access from anywhere in the world.\u00a0 The site is storing this information on behalf of the patients, not their doctor.[66. In contrast, some sites store and manage health information on behalf of doctors. These sites are treated differently under the regulation. See<\/em> discussion under \u201cBusiness Associates,\u201d supra<\/em> Part IV.B.] Personal files can include records of visits to the doctor or hospital, lab reports, medications, allergies, family history and immunizations.\u00a0 The information is provided by the patient in a variety of ways (such as via fax and direct entry).\u00a0 The site, however, is not covered by the privacy rule \u2013 it is not a provider, a health plan or a health care clearinghouse.\u00a0 Patients who use these sites essentially are relying on the site\u2019s own privacy policy for protection.<\/p>\n\n Patients may also authorize their doctor to send health information directly to PersonalMD.com for inclusion in their online medical record.\u00a0 The fact that the information is transmitted to the site by the doctor does not change the situation\u2014it loses its protection under the privacy regulation once it leaves the doctor\u2019s office.[67. See<\/em> Privacy Rule, \u00a7 164.508(c), available at http:\/\/www.hhs.gov\/ocr\/regtext.html<\/a>.] In fact, the privacy regulation recognizes that this can occur and requires that authorization forms include a statement that health information released pursuant to the authorization may no longer be protected by the privacy rule.[68. See id.<\/em>] PersonalMD.com has strict policies against the sharing of personally identifiable information without an individual\u2019s permission,[69. The PersonalMD privacy policy states, \u201cAs a general rule, PersonalMD will not disclose any of your personally identifiable information without your permission. The exception shall be under special circumstances, such as when we believe in good faith that the law requires it or under the circumstances described below\u2026. PersonalMD will never rent or sell your health-related information. This site has security measures in place to protect the loss, misuse and alteration of the information under our control.\u201d Available at http:\/\/www.personalmd.com\/privacypolicy.shtml<\/a>.] but privacy policies are not required by law and they are subject to change at any time.\u00a0 Furthermore, PersonalMD.com advertisers or Web sites that have links on PersonalMD.com may collect personally identifiable information about individuals, but these third party sites are not required to comply with PersonalMD.com\u2019s privacy policy.<\/p>","protected":false},"excerpt":{"rendered":" Introduction Every day people go online to get information about a medical condition or symptom, fill a prescription, get an insurance quote, participate in a chat room, or fill out a health assessment.\u00a0 All of these activities involve the exchange of information with or without the consent of the individual, and with or without their 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for Purchasing Health-related Products<\/h3>\n\n
Sites Providing Health Care \u201cTreatment\u201d<\/h3>\n\n
Patient-driven Sites<\/h3>\n\n