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</o:shapelayout></xml><![endif]--></head><body bgcolor=white lang=EN-US link="#330099" vlink="#999999"><div class=WordSection1><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>I think 21<sup>st</sup> Century Cures established one line to consider with regards to what is in scope for the FDA to regulate.<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'>TITLE III—DEVELOPMENT <o:p></o:p></span></p><p class=MsoNormal><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Sec. 3060. Clarifying Medical Software Regulation (pg. 257-264) <o:p></o:p></span></p><p class=MsoListParagraph style='text-indent:-.25in;mso-list:l0 level1 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:Symbol;color:#1F497D'><span style='mso-list:Ignore'>·<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>The term ‘device’ shall be excluded from regulation by the FDA if the software function of the device is intended for: <o:p></o:p></span></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l0 level2 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:"Courier New";color:#1F497D'><span style='mso-list:Ignore'>o<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Such purposes as administrative support of a health care facility, including the processing and maintenance of financial records, claims or billing information, appointment schedules, business analytics, population health management, and laboratory workflow, among others; <o:p></o:p></span></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l0 level2 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:"Courier New";color:#1F497D'><span style='mso-list:Ignore'>o<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Maintaining or encouraging a healthy lifestyle, unrelated to diagnosis, cure, mitigation, prevention, or treatment of a disease or condition. <o:p></o:p></span></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l0 level2 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:"Courier New";color:#1F497D'><span style='mso-list:Ignore'>o<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Electronic patient records, including patient-provided information, to the extent that such records are intended to transfer, store, convert formats, or display the equivalent of a paper medical chart, as long as: <o:p></o:p></span></p><p class=MsoListParagraph style='margin-left:1.5in;text-indent:-.25in;mso-list:l0 level3 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:Wingdings;color:#1F497D'><span style='mso-list:Ignore'>§<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>The records were created, stored, transferred, or reviewed by health care professionals, or by individuals working under supervision of such professionals <o:p></o:p></span></p><p class=MsoListParagraph style='margin-left:1.5in;text-indent:-.25in;mso-list:l0 level3 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:Wingdings;color:#1F497D'><span style='mso-list:Ignore'>§<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Such records are certified under section 3001(c)(5) of the Public Health Service Act</span><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'><o:p></o:p></span></p><p class=MsoListParagraph style='margin-left:1.5in;text-indent:-.25in;mso-list:l0 level3 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:Wingdings;color:#1F497D'><span style='mso-list:Ignore'>§<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>It doesn’t include software intended to interpret or analyze patient records, including medical image data <o:p></o:p></span></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l0 level2 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:"Courier New";color:#1F497D'><span style='mso-list:Ignore'>o<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Transferring, storing, converting formats, or displaying clinical laboratory tests or other device data results; findings by a health care professional with respect to such data and results, general information about such findings, and general background information about such laboratory test or other device, unless such function is intended to interpret or analyze clinical laboratory test or other device data, results, and findings; <o:p></o:p></span></p><p class=MsoListParagraph style='margin-left:1.0in;text-indent:-.25in;mso-list:l0 level2 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:"Courier New";color:#1F497D'><span style='mso-list:Ignore'>o<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>(Unless) the Software function is intended to acquire, process, or analyze medical images or a signal from an in vitro diagnostic device or a pattern or signal from a signal acquisition system for the purpose of: <o:p></o:p></span></p><p class=MsoListParagraph style='margin-left:1.5in;text-indent:-.25in;mso-list:l0 level3 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:Wingdings;color:#1F497D'><span style='mso-list:Ignore'>§<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Displaying, analyzing, or printing medical information about a patient or other medical information <o:p></o:p></span></p><p class=MsoListParagraph style='margin-left:1.5in;text-indent:-.25in;mso-list:l0 level3 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:Wingdings;color:#1F497D'><span style='mso-list:Ignore'>§<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Supporting or providing recommendations to a health care professional about prevention, diagnosis, or treatment of a disease or condition. <o:p></o:p></span></p><p class=MsoListParagraph style='margin-left:1.5in;text-indent:-.25in;mso-list:l0 level3 lfo2'><![if !supportLists]><span style='font-size:11.0pt;font-family:Wingdings;color:#1F497D'><span style='mso-list:Ignore'>§<span style='font:7.0pt "Times New Roman"'> </span></span></span><![endif]><span style='font-size:11.0pt;font-family:"Calibri","sans-serif";color:#1F497D'>Enabling health care professionals to independently review the basis for such recommendations that software presents so that it is not the intent that health care professional rely primarily on any of such recommendations to make a clinical diagnosis or treatment decision regarding an individual patient.<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'>You probably want to look at the section in its entirety for more details.<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'>Is there any useful criteria for your purposes that you can derive from this?<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:image001.jpg@01D2732A.DA3039E0"></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 [<a href="mailto:openid-specs-heart-bounces@lists.openid.net">mailto:openid-specs-heart-bounces@lists.openid.net</a>] <b>On Behalf Of </b>Glen Marshall [SRS]<br><b>Sent:</b> Friday, January 20, 2017 2:10 PM<br><b>To:</b> HEART List<br><b>Subject:</b> [Openid-specs-heart] What is Health Data?<o:p></o:p></span></p></div></div><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>In our discussion this past week we did not drill-down on use cases about sharing data from personal health data collection devices, e.g., Fitbit or environmental activity monitors, or medically prescribed devices, e.g., Holter monitors. In the case of medically prescribed monitors, the data they collect is clearly health data. On the other hand, data on personal wearable devices only becomes medical data when it is shared for that purpose. Activity monitors are in-between, as they can be used in an non-medical assisted living setting or in medical long term care.<o:p></o:p></p><p class=MsoNormal><o:p> </o:p></p><p class=MsoNormal>Where do we set the boundary between health data and other data? What do we do when that boundary shifts, as it has for wearable devices over the last couple of decades? What is the mechanism for granting permission for medical use when such devices lack a UX? Are there existing policies for this, i.e., is it in scope for HEART, or should we make recommendations for policy development?<o:p></o:p></p><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Helvetica","sans-serif"'><o:p> </o:p></span></p><div class=MsoNormal align=center style='text-align:center'><span style='font-size:11.0pt;font-family:"Helvetica","sans-serif"'><hr size=2 width="100%" noshade style='color:black' align=center></span></div><p class=MsoNormal style='mso-margin-top-alt:auto;mso-margin-bottom-alt:auto'><span style='font-size:11.0pt;font-family:"Helvetica","sans-serif"'>Glen F. Marshall<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></span></p><p class=MsoNormal><o:p> </o:p></p></div></body></html>