<html xmlns:v="urn:schemas-microsoft-com:vml" xmlns:o="urn:schemas-microsoft-com:office:office" xmlns:w="urn:schemas-microsoft-com:office:word" xmlns:m="http://schemas.microsoft.com/office/2004/12/omml" xmlns="http://www.w3.org/TR/REC-html40"><head><meta http-equiv=Content-Type content="text/html; charset=utf-8"><meta name=Generator content="Microsoft Word 14 (filtered medium)"><!--[if !mso]><style>v\:* {behavior:url(#default#VML);}
o\:* {behavior:url(#default#VML);}
w\:* {behavior:url(#default#VML);}
.shape {behavior:url(#default#VML);}
</style><![endif]--><style><!--
/* Font Definitions */
@font-face
{font-family:Helvetica;
panose-1:2 11 6 4 2 2 2 2 2 4;}
@font-face
{font-family:Wingdings;
panose-1:5 0 0 0 0 0 0 0 0 0;}
@font-face
{font-family:Wingdings;
panose-1:5 0 0 0 0 0 0 0 0 0;}
@font-face
{font-family:Calibri;
panose-1:2 15 5 2 2 2 4 3 2 4;}
@font-face
{font-family:Tahoma;
panose-1:2 11 6 4 3 5 4 4 2 4;}
/* Style Definitions */
p.MsoNormal, li.MsoNormal, div.MsoNormal
{margin:0in;
margin-bottom:.0001pt;
font-size:12.0pt;
font-family:"Times New Roman","serif";
color:black;}
a:link, span.MsoHyperlink
{mso-style-priority:99;
color:blue;
text-decoration:underline;}
a:visited, span.MsoHyperlinkFollowed
{mso-style-priority:99;
color:purple;
text-decoration:underline;}
p
{mso-style-priority:99;
mso-margin-top-alt:auto;
margin-right:0in;
mso-margin-bottom-alt:auto;
margin-left:0in;
font-size:12.0pt;
font-family:"Times New Roman","serif";
color:black;}
p.MsoAcetate, li.MsoAcetate, div.MsoAcetate
{mso-style-priority:99;
mso-style-link:"Balloon Text Char";
margin:0in;
margin-bottom:.0001pt;
font-size:8.0pt;
font-family:"Tahoma","sans-serif";
color:black;}
span.EmailStyle18
{mso-style-type:personal-reply;
font-family:"Calibri","sans-serif";
color:#1F497D;}
span.BalloonTextChar
{mso-style-name:"Balloon Text Char";
mso-style-priority:99;
mso-style-link:"Balloon Text";
font-family:"Tahoma","sans-serif";
color:black;}
.MsoChpDefault
{mso-style-type:export-only;
font-size:10.0pt;}
@page WordSection1
{size:8.5in 11.0in;
margin:1.0in 1.0in 1.0in 1.0in;}
div.WordSection1
{page:WordSection1;}
/* List Definitions */
@list l0
{mso-list-id:438913915;
mso-list-template-ids:-963728406;}
@list l0:level1
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:.5in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Symbol;}
@list l0:level2
{mso-level-number-format:bullet;
mso-level-text:o;
mso-level-tab-stop:1.0in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:"Courier New";
mso-bidi-font-family:"Times New Roman";}
@list l0:level3
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:1.5in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
@list l0:level4
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:2.0in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
@list l0:level5
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:2.5in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
@list l0:level6
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:3.0in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
@list l0:level7
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:3.5in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
@list l0:level8
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:4.0in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
@list l0:level9
{mso-level-number-format:bullet;
mso-level-text:;
mso-level-tab-stop:4.5in;
mso-level-number-position:left;
text-indent:-.25in;
mso-ansi-font-size:10.0pt;
font-family:Wingdings;}
ol
{margin-bottom:0in;}
ul
{margin-bottom:0in;}
--></style><!--[if gte mso 9]><xml>
<o:shapedefaults v:ext="edit" spidmax="1026" />
</xml><![endif]--><!--[if gte mso 9]><xml>
<o:shapelayout v:ext="edit">
<o:idmap v:ext="edit" data="1" />
</o:shapelayout></xml><![endif]--></head><body bgcolor=white lang=EN-US link=blue vlink=purple><div class=WordSection1><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>I ran two IRBs (Cancer Adult and Peds) for a while in a previous life. As you state:<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal>“The key issue is whether an "informed consent" <document> is sufficient to provide <enough> information to the patient, or whether it's necessary to ensure the patient is actually informed by it.”<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>As this has been debated since the end of WWII, I full heartedly support the notion of keeping this debate out of the scope for HEART and make the assumption that from the system perspective there is a triggering event that conveys that the consumer has satisfied the policy requirements established to demonstrate informed consent.<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Aaron<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><div><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Aaron Seib, CEO<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>@CaptBlueButton <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'> (o) 301-540-2311<o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>(m) 301-326-6843<o:p></o:p></span></p><p class=MsoNormal><a href="nate-trust.org"><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D;text-decoration:none'><img border=0 width=205 height=48 id="Picture_x0020_1" src="cid:image003.jpg@01D0F6EB.3382EC30"></span></a><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p></o:p></span></p></div><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p> </o:p></span></p><div><div style='border:none;border-top:solid #B5C4DF 1.0pt;padding:3.0pt 0in 0in 0in'><p class=MsoNormal><b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:windowtext'>From:</span></b><span style='font-size:10.0pt;font-family:"Tahoma","sans-serif";color:windowtext'> Openid-specs-heart [mailto:openid-specs-heart-bounces@lists.openid.net] <b>On Behalf Of </b>Glen Marshall [SRS]<br><b>Sent:</b> Thursday, September 24, 2015 4:01 PM<br><b>To:</b> HEART List<br><b>Subject:</b> [Openid-specs-heart] Additional Considerations for the "Alice Consents to Clinical Research" Use Case<o:p></o:p></span></p></div></div><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Team,<br><br>Adding to our discussion, there are two patient PHR feedback loops in the "Alice Consents to Clinical Research" use case: <span style='font-size:9.5pt;font-family:"Helvetica","sans-serif";color:#222222;background:white'><br><br></span><o:p></o:p></p><ul type=disc><li class=MsoNormal style='mso-margin-top-alt:auto;margin-bottom:12.0pt;mso-list:l0 level1 lfo1'>The EHR-to-PHR link is only incidental to the use case, as it was covered in our first use case. However, the translation of clinical data to a consumer-understandable form is of possible interest as a precondition. The key issue is whether in "informed consent" it is sufficient to provide information to the patient, or whether it's necessary to ensure the patient is actually informed by it. Is there a trigger event that indicates the "informed" precondition has been met? <br><br>I don't want to lead us all down a rabbit hole, though, so I'd like the specification of that event, other than Alice signing the consent form, to be declared out of scope.<o:p></o:p></li><li class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto;mso-list:l0 level1 lfo1'>The CDRN-to-PHR link is important to the complete use case. The technical issue is how to report disclosures to a patient whose data is pseudonymized in the CDRN. I don't think HEART will solve it, we need to include a a "black box" that re-identifies patients for communication to the patients and their care providers. For this use case we need to have an UMA permission in the AS, probably from the IRB, that allows the "black box" to reidentify an incoming transaction for the purpose of disclosure, but not for any other purpose.<o:p></o:p></li></ul><p class=MsoNormal>Your thoughts?<br><br>Best,<br>Glen <span style='font-size:9.5pt;font-family:"Arial","sans-serif";color:#222222;background:white'><br><br><br></span><o:p></o:p></p><div><p class=MsoNormal>-- <o:p></o:p></p><p><b>Glen F. Marshall</b><br>Consultant<br>Security Risk Solutions, Inc.<br>698 Fishermans Bend<br>Mount Pleasant, SC 29464<br>Tel: (610) 644-2452<br>Mobile: (610) 613-3084<br><a href="mailto:gfm@securityrs.com">gfm@securityrs.com</a><br><a href="http://www.SecurityRiskSolutions.com">www.SecurityRiskSolutions.com</a><o:p></o:p></p></div></div></body></html>