Patent Publication Number: US-8979133-B2

Title: Data carrier for health related information

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
     This application is a divisional of U.S. patent application Ser. No. 10/822,386 filed Apr. 12, 2004 now U.S. Pat. No. 7,758,080. 
    
    
     STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT 
     Not applicable. 
     BACKGROUND OF THE INVENTION 
     The Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule created national standards to protect individuals&#39; medical records and other personal health information. It protects all individually identifiable health information that is held or transmitted by a covered entity or its business associate, in any form or media, whether electronic, paper or oral. 
     It is considered important to minimize even the incidental disclosure of patient information to the extent possible. Health care providers have adopted a number of changes in their standard operating procedures to limit the incidental disclosure of patient health information beyond what is required to provide medical services to the patient in an effective and efficient manner. For example, most health care facilities take steps to make sure patient information is not retrievable by unauthorized individuals from discarded documents, records, and other materials containing identifiable patient information. Many organizations now require that such materials be shredded or incinerated to avoid the risk of disclosure. These materials may include empty plastic pill vials, discarded patient ID bracelets, and used plastic bags having patient labels. This requires that bins for collecting these materials be located through the facility, and that employees spend time to empty the bins and shred or burn the contents. As an alternative, some organizations mark through the name of the patient with a marking pen at the time that the material is discarded. This is also time consuming and may not be completely effective in rendering the name of the patient illegible. 
     It is seen, therefore, that there is a need for a data carrier for providing health information related to a patient in which the health information and the identity of the patient can be simply and efficiently disassociated. 
     SUMMARY OF THE INVENTION 
     These needs are met by a data carrier for providing health related information regarding a patient, and for facilitating compliance with HIPAA by the obscuring the association between the name of the patient and the health related information when the data carrier is to be discarded. The data carrier comprises a release liner, a health information label having an upper surface and a lower surface, and a pressure sensitive adhesive coating on the lower surface of the health information label, securing the health information label to the release liner. The health information label includes a first area on the upper surface for indicia specifying health related information and a second area on the upper surface for indicia specifying the identity of a patient. A masking label is integral with the health information label. The masking label has blockout indicia printed thereon. A die cut is provided in the release liner, defining a removable liner piece beneath the masking label. The removable liner piece is removable from the release liner along with the health information label, and remains thereon when the health information label is applied to a surface. The removable liner piece permits the removal of the masking label from the health information label. The masking label is applied over one or both of the first and second areas to obscure the association between the name of the patient and the health related information when the data carrier is to be discarded. 
     The first and second areas are on a first portion of the health information label. The masking label is on a second portion of the health information label. The first and second portions are separated by a line of die cut perforations. The first and second portions of the health information label may be substantially equal in size and shape, in which case the masking label encompasses substantially all of the second portion. The removable liner piece beneath the masking label may be larger than the masking label. 
     The pressure sensitive adhesive coating on the lower surface of the label may comprise a permanent adhesive. Applying the masking label over one or both of the first and second areas obscures the association between the name of the patient and the patient&#39;s health related information when the data carrier is to be discarded. This may occur, for example, when the health information label has been placed on a prescription medicine container, and the container is being discarded. The health information label may define a plurality of scores or cuts, so that an attempt to remove the masking label from the upper surface of the health information label will result in the destruction of the health information label, rendering the identity of the patient or the health information, or both, unreadable. 
     The masking label may be smaller than the removable liner piece beneath the masking label. With this arrangement, the removable liner piece may extend beyond the edge of the health information label such that the removable liner piece can be used to remove the masking label. 
     The data carrier may include a release liner, a health information label having an upper surface and a lower surface, and a pressure sensitive adhesive coating on a portion of the lower surface of the health information label, securing the health information label to the release liner. The health information label may include a first area on its upper surface for indicia specifying health related information and a second area on its upper surface for indicia specifying the identity of a patient. The lower surface of the health information label beneath one or both of the first areas on the upper surface may be substantially free of pressure sensitive adhesive. A second label, integral with the health information label, is defined by a perforation line enclosing the part of the information label that is substantially free of pressure sensitive adhesive. The lower surface of the health information label beneath one or both of the first areas on the upper surface is substantially free of pressure sensitive adhesive such that the removal of the second label from the health information label obscures the association between the name of the patient and the health related information when the data carrier is to be discarded. The pressure sensitive adhesive coating on the lower surface of the label may comprise a permanent adhesive. 
     A data carrier may comprise a release liner, a health information label having an upper surface and a lower surface, and a pressure sensitive adhesive coating on the lower surface of the health information label, securing the health information label to the release liner. The health information label includes a first area on the upper surface for indicia specifying health related information, and a second area on the upper surface for indicia specifying the identity of a patient. A second label, integral with the health information label, is defined by a perforation line enclosing at least a portion of one of the first and second areas. A die cut in the release liner defining a removable liner piece beneath the second label. The removable liner piece is removable from the release liner with the health information label and remains thereon when the health information label is applied to a surface. The removable liner piece permits the subsequent removal of the second label from the health information label after the health information is applied to a surface. By this arrangement, the removal of the second label from the health information label obscures the association between the name of the patient and the health related information. 
     The second label may be smaller than the removable liner piece beneath the second label. The removable liner piece extends beyond the edge of the health information label such that the removable liner piece may be used to remove the second label. 
     A data carrier may comprise a release liner, a health information label having an upper surface and a lower surface, a pressure sensitive adhesive coating on a portion of the lower surface of the health information label, securing the health information label to the release liner, and a release coating on the balance of the lower surface of the health information label. The health information label includes a first area on the upper surface for indicia specifying health related information and a second area on the upper surface for indicia specifying the identity of a patient. The carrier further includes a masking label having blockout indicia printed thereon. The masking label carries a pressure sensitive coating, is integral with the release liner, and is positioned in alignment with the release coating on the balance of the lower surface of the health information label. A die cut in the health information label defines a removable label piece surrounding the release coating on the lower surface of the health information label. The removable label piece is removable with the health information label from the release liner, and remains therewith when the health information label is applied to a surface. The masking label is removable so that it can be applied over one or both of the first and second areas to obscure the association between the name of the patient and the health related information when the data carrier is to be discarded. The masking label may be defined by a die cut in the release liner. 
     Accordingly, it is an object of the present invention to provide a data carrier for providing health related information regarding a patient, and for facilitating compliance with HIPAA by obscuring the association between the name of the patient and the health related information when the data carrier is to be discarded. This and other objects will be apparent from the description and claims which follow. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a plan view of a first embodiment of the present invention; 
         FIG. 2  is a plan view of a second embodiment of the present invention; 
         FIG. 3  is plan view of a third embodiment of the present invention; 
         FIG. 4  is a plan view of a fourth embodiment of the present invention; 
         FIG. 5  is a plan view of a fifth embodiment of the present invention; 
         FIG. 6  is a plan view of the front of a sixth embodiment of the present invention; 
         FIG. 7  is a sectional view of the embodiment of  FIG. 6 , taken generally along line  7 - 7  in  FIG. 6 ; and 
         FIG. 8  is a plan view of the back of the embodiment of  FIG. 6 . 
     
    
    
     DETAIL DESCRIPTION OF THE PREFERRED EMBODIMENTS 
     Reference is made to  FIG. 1  which illustrates a data carrier  10  according to the present invention for providing health related information regarding a patient, and for facilitating compliance with HIPAA. As explained more fully, below, the data carrier is configured to permit the association between the name of the patient (“John Doe” in the example) and the health related information (“Amoxicillin 250 mg” in the example) to be obscured when the data carrier is to be discarded. The data carrier includes a release liner  12 , a health information label  14  having an upper surface  16  and a lower surface, and a pressure sensitive adhesive coating on the lower surface of the health information label  14 , securing the health information label to the release liner  12 . The health information label  14  is made up of a first portion  18  and a second portion  20 , with the first and second portions being separated by a line  22  of die cut perforations  22 . Alternatively, die cut line  22  may be a continuous die cut. The label  14  includes a first area  24  on the upper surface  16  for indicia specifying health related information, such as an identification of medication, and a second area  26  on the upper surface  16  for indicia specifying the identity of a patient. 
     A masking label  28  having Tamper resistant die cuts  30  therein and further including blockout indicia (not shown) is integral with the health information label  14 . The blockout indicia may be printed on either the upper or lower surface of the label and may take any of a number of known forms to make it more difficult to read printed information beneath the label  28  on a surface to which the label  28  is applied. The label  28  is defined by a die cut  32  in portion  20  of label  14 . The die cut  32  can be a continuous die cut or, alternatively, a line of perforations. Beneath the masking label  28  is a die cut  34  in the release liner defining a removable liner piece  36 . Die cut  34  may also be a continuous die cut or, alternatively, a line of perforations. As depicted in  FIG. 1 , the release liner  12  is a continuous liner, of the type upon which multiple labels may be positioned for printing and subsequent application to pharmaceutical containers. 
     The removable liner piece  36  can be removed from the release liner with the health information label  14  and remains thereon when the health information label  14  is applied to a surface, such as the outer surface of a pharmaceutical container. When applied in this manner, the liner piece  36  remains between the label  14  and the container surface and is surrounded on three sides by adhesive that secures the lower surface of the label  14  to the container surface. When the container is emptied and about to be discarded, the masking label  28  is removed from the liner piece  36  so that the masking label  28  can be applied over one or both of the first and second areas  24  and  26  to obscure the association between the name of the patient and the health related information. 
     The pressure sensitive adhesive coating on the lower surface of the label  14  may comprise a permanent adhesive. By this arrangement, applying the masking label  28  over one or both of the first and second areas  24  and  26  to obscure the association between the name of the patient and the health related information when the data carrier is to be discarded obscures the association between the name of the patient and the health related information. Because the adhesive is permanent, an attempt to remove the masking label  28  from the health information label  14  will result in the destruction of the label  14  to a degree needed to render the covered information illegible. To make it more difficult for a masking label  28  to be removed from the upper surface of the health information label  14 , the health information label  14  may define a plurality of scores or cuts  30 . These scores or cuts  30  make the label  14  somewhat fragile, so that an attempt to remove the masking label  28  from the upper surface  16  of the health information label  14  will result in the destruction of the health information label  14 , rendering the identity of the patient or the health information, or both, unreadable. 
     As shown in  FIG. 1 , the masking label  28  may be significantly smaller than either of the portions  18  and  20 . Further, the masking label  28  may be smaller than the removable liner piece  36  beneath the masking label  28 . With the configuration illustrated, the removable liner piece  36  will extend beyond the edge of the health information label  14  when the label  14  has been removed from line  12  and applied to a container surface. As a consequence, the removable liner piece  36  may be easily grasped and used to remove the masking label from the container surface. The masking label  28  may then be removed from the liner piece  36  and applied over the name of the patient, thereby disassociating the identity of the patient and the medication prescribed and administered to the patient. 
     Reference is made to  FIG. 2 , which shows a second embodiment of the invention, with elements that correspond to those of the embodiment of  FIG. 1  being indicated with corresponding reference numerals. In this embodiment, the first and second portions  18  and  20  of the health information label  14  may be substantially equal in size and shape. It will be noted that the masking label  28  encompasses substantially all of the second portion  20 . Further, it will be noted that the perforation line  34  is substantially larger than the portion  20 . As a consequence, when the label  14  is removed from the line  12  and applied to a container surface, the portion  20  and the removable liner piece  36  will simply hang freely from the balance of the label  14 , with that portion of the label  14  above perforation line  22  being secured to the surface by permanent adhesive. When it is desired to obscure the association between the name of the patient in area  26  and the health related information in area  24 , the label  14  is simply torn along line  22 , the portion  20  is removed from the piece  36 , and the masking label  28  applied over one or both areas  24  and  26 . 
     Reference is made to  FIG. 3 , which shows a third embodiment of the invention, with elements that correspond to those of the embodiment of  FIG. 1  being indicated with corresponding reference numerals. In the embodiment of  FIG. 3 , the health information label  14  essentially surrounds the masking label  28  on three sides. The masking label  28  is shown as essentially all black; however, the masking label  28  may bear jumbled indicia, opaque materials of some sort, or other blocking means. 
     Reference is made to  FIG. 4 , which shows a fourth embodiment of the invention, with elements that correspond to those of the embodiment of  FIG. 1  being indicated with corresponding reference numerals. The data carrier  10  includes a release liner  12 , and a health information label  40  having an upper surface  42  and a lower surface. The health information label  40  includes a first area  44  on the upper surface  46  for indicia specifying health related information (for example, “Amoxicillin 250 mg”) and a second area  48  on the upper surface  42  for indicia specifying the identity of a patient (for example, “John Doe”). A pressure sensitive adhesive coating is provided on a portion of the lower surface of the health information label  40 , indicated by stippling in  FIG. 4 . The adhesive secures the health information label  40  to the release liner  12 . The lower surface of the health information label  40  beneath area  48  is substantially free of pressure sensitive adhesive. A second label  49 , integral with the health information label  40 , is defined by a perforation line  50 . 
     In use, the label  40  with integral label  49  is removed from the release liner and secured to a container by the pressure sensitive adhesive. When the container is to be discarded, the label  49  is removed. This effectively disassociates the identity of the patient from the prescription information. The removed label can then be separately destroyed. It will be appreciated that the applied to the arrangement of  FIG. 4  can be modified, such that the label  49  encompasses area  44  or both area  44  and area  48 . The important thing is that the association between the medication and identity of the patient be eliminated before the labeled container is discarded. 
     Reference is made to  FIG. 5 , which shows a fifth embodiment of the invention, with elements that correspond to those of the embodiment of  FIG. 1  being indicated with corresponding reference numerals. The data carrier of  FIG. 5  includes a release liner  12 , and a health information label  52  having an upper surface  54  and a lower surface. The label  52  includes a first area  56  on the upper surface  54  for indicia specifying health related information and a second area  58  on the upper surface  54  for indicia specifying the identity of a patient. A pressure sensitive adhesive coating on the lower surface of the health information label  52  secures the health information label  52  to the release liner  12 . A second label  60  is integral with the health information label  60  and is defined by a perforation line  62  enclosing at least a portion of one of the first and second areas. A die cut  64  in the release liner  12  defines a removable liner piece  66  beneath the second label  60 . 
     In use, the label  52  is applied to the container surface with the removable liner piece held behind the label  52 . When the container is to be discarded, the label  60 , or the label  60  and liner piece  66  are removed from the container and discarded separately. This obscures the association between the identity of the patient and the health related information. It will be appreciated that in an alternative arrangement, the health information, or that both the identity of the patient and the health information, may be printed on the label  60 . In any event, the removal and separate disposal of the label eliminates the association between the patient and the health related information. It will be noted that the second label  60  is smaller than the removable liner piece beneath  66  the second label, and that the removable liner piece  66  extends beyond the edge of the health information label  52  such that the removable liner piece  66  may be used to remove the second label. 
     Reference is made to  FIGS. 6-8 , which show a sixth embodiment of the invention. The thicknesses of the various layers in  FIG. 7  are exaggerated for clarity of illustration. The data carrier  70  includes a release liner  72 , and a health information label  74  having an upper surface  76  and a lower surface. The label  74  includes a first area  78  on the upper surface  76  for indicia specifying health related information (such as “Amoxicillin 250 mg”) and a second area  80  on the upper surface  76  for indicia specifying the identity of a patient (such as “John Doe, Rm  204 ; Bed- 2 ”). A pressure sensitive adhesive coating  82  on a portion of the lower surface of the health information label  74  secures the health information label  74  to the release liner  72 . The balance of the lower surface of the health information label  74  has a release coating  84 . A masking label  86  has blockout indicia printed thereon and is defined by a die cut  87  in the liner  72 . The masking label  86  carries a pressure sensitive coating  88  and is integral with the release liner  72 . The masking label  86  is positioned in alignment with the release coating  84  on the lower surface of the health information label  74 . A perf cut  90  in the health information label  74  defines a removable label piece  92 . The perf cut  90  generally surrounds the release coating  84  on the lower surface of the health information label  74 . The perf cut  90  is positioned slightly inward from the position of the silicone coating to allow tolerance for die cutting. 
     In use, the label  74  is removed from the release liner with the masking label attached to the label  74 . The label  74  is secured to a container. When the container is to be discarded, the masking label  86  and removable label piece  92 , are separated from the balance of the label  74 . The masking label  86  is then separated from the removable label piece  92 . The removable label piece  92  is discarded and the masking label  86  is then secured to the label  74 . The masking label  86  is applied over one or both of the first and second areas  78  and  80  to obscure the association between the name of the patient and the health related information when the data carrier is to be discarded. 
     Having described the present invention in detail and by reference to different embodiments thereof, it will be apparent that certain modifications and variations are possible without departing from the scope of the invention defined in the appended claims.