§170.403. Communications. — Inbound Citations

(3) Section 170.403;

(ii) For communications about one or more of the subject matters enumerated in paragraph (a)(1) of this section that is not entitled to unqualified protection under paragraph (a)(2)(i) of this section, a health IT developer may prohibit or restrict communications only as expressly permitted by paragraphs (a)(2)(ii)(A) through (E) of this section.

(A) (1) A health IT developer may prohibit or restrict the communications of the developer's employees or contractors.

(2) A self-developer must not prohibit or restrict communications of users of their health IT who are also employees or contractors.

(B) A health IT developer may prohibit or restrict communications that disclose information about non-user-facing aspects of the developer's health IT.

(C) A health IT developer may prohibit or restrict communications that involve the use or disclosure of intellectual property existing in the developer's health IT (including third-party intellectual property), provided that any prohibition or restriction imposed by a developer must be no broader than necessary to protect the developer's legitimate intellectual property interests and consistent with all other requirements of paragraph (a)(2)(ii) of this section. A restriction or prohibition is deemed broader than necessary and inconsistent with the requirements of paragraph (a)(2)(ii) of this section if it would restrict or preclude a public display of a portion of a work subject to copyright protection (without regard to whether the copyright is registered) that would reasonably constitute a “fair use” of that work.

(D) A health IT developer may require persons who communicate screenshots or video to—

(1) Not alter the screenshots or video, except to annotate the screenshots or video or resize the screenshots or video;

(2) Limit the sharing of screenshots to the relevant number of screenshots needed to communicate about the health IT regarding one or more of the six subject areas in paragraph (a)(1) of this section; and

(3) Limit the sharing of video to:

(i) The relevant amount of video needed to communicate about the health IT regarding one or more of the six subject areas in paragraph (a)(1) of this section; and

(ii) Only videos that address temporal matters that cannot be communicated through screenshots or other forms of communication.

(E) A health IT developer may prohibit or restrict communications that disclose information or knowledge solely acquired in the course of participating in pre-market product development and testing activities carried out for the benefit of the developer or for the joint benefit of the developer and communicator. A developer must not, once the subject health IT is released or marketed for purposes other than product development and testing, and subject to the permitted prohibitions and restrictions described in paragraph (a)(2)(ii) of this section, prohibit or restrict communications about matters enumerated in paragraph (a)(1) of this section.

(ii) For communications about one or more of the subject matters enumerated in paragraph (a)(1) of this section that is not entitled to unqualified protection under paragraph (a)(2)(i) of this section, a health IT developer may prohibit or restrict communications only as expressly permitted by paragraphs (a)(2)(ii)(A) through (E) of this section.

(A) (1) A health IT developer may prohibit or restrict the communications of the developer's employees or contractors.

(2) A self-developer must not prohibit or restrict communications of users of their health IT who are also employees or contractors.

(B) A health IT developer may prohibit or restrict communications that disclose information about non-user-facing aspects of the developer's health IT.

(C) A health IT developer may prohibit or restrict communications that involve the use or disclosure of intellectual property existing in the developer's health IT (including third-party intellectual property), provided that any prohibition or restriction imposed by a developer must be no broader than necessary to protect the developer's legitimate intellectual property interests and consistent with all other requirements of paragraph (a)(2)(ii) of this section. A restriction or prohibition is deemed broader than necessary and inconsistent with the requirements of paragraph (a)(2)(ii) of this section if it would restrict or preclude a public display of a portion of a work subject to copyright protection (without regard to whether the copyright is registered) that would reasonably constitute a “fair use” of that work.

(D) A health IT developer may require persons who communicate screenshots or video to—

(1) Not alter the screenshots or video, except to annotate the screenshots or video or resize the screenshots or video;

(2) Limit the sharing of screenshots to the relevant number of screenshots needed to communicate about the health IT regarding one or more of the six subject areas in paragraph (a)(1) of this section; and

(3) Limit the sharing of video to:

(i) The relevant amount of video needed to communicate about the health IT regarding one or more of the six subject areas in paragraph (a)(1) of this section; and

(ii) Only videos that address temporal matters that cannot be communicated through screenshots or other forms of communication.

(E) A health IT developer may prohibit or restrict communications that disclose information or knowledge solely acquired in the course of participating in pre-market product development and testing activities carried out for the benefit of the developer or for the joint benefit of the developer and communicator. A developer must not, once the subject health IT is released or marketed for purposes other than product development and testing, and subject to the permitted prohibitions and restrictions described in paragraph (a)(2)(ii) of this section, prohibit or restrict communications about matters enumerated in paragraph (a)(1) of this section.

(ii) For communications about one or more of the subject matters enumerated in paragraph (a)(1) of this section that is not entitled to unqualified protection under paragraph (a)(2)(i) of this section, a health IT developer may prohibit or restrict communications only as expressly permitted by paragraphs (a)(2)(ii)(A) through (E) of this section.

(A) (1) A health IT developer may prohibit or restrict the communications of the developer's employees or contractors.

(2) A self-developer must not prohibit or restrict communications of users of their health IT who are also employees or contractors.

(B) A health IT developer may prohibit or restrict communications that disclose information about non-user-facing aspects of the developer's health IT.

(C) A health IT developer may prohibit or restrict communications that involve the use or disclosure of intellectual property existing in the developer's health IT (including third-party intellectual property), provided that any prohibition or restriction imposed by a developer must be no broader than necessary to protect the developer's legitimate intellectual property interests and consistent with all other requirements of paragraph (a)(2)(ii) of this section. A restriction or prohibition is deemed broader than necessary and inconsistent with the requirements of paragraph (a)(2)(ii) of this section if it would restrict or preclude a public display of a portion of a work subject to copyright protection (without regard to whether the copyright is registered) that would reasonably constitute a “fair use” of that work.

(D) A health IT developer may require persons who communicate screenshots or video to—

(1) Not alter the screenshots or video, except to annotate the screenshots or video or resize the screenshots or video;

(2) Limit the sharing of screenshots to the relevant number of screenshots needed to communicate about the health IT regarding one or more of the six subject areas in paragraph (a)(1) of this section; and

(3) Limit the sharing of video to:

(i) The relevant amount of video needed to communicate about the health IT regarding one or more of the six subject areas in paragraph (a)(1) of this section; and

(ii) Only videos that address temporal matters that cannot be communicated through screenshots or other forms of communication.

(E) A health IT developer may prohibit or restrict communications that disclose information or knowledge solely acquired in the course of participating in pre-market product development and testing activities carried out for the benefit of the developer or for the joint benefit of the developer and communicator. A developer must not, once the subject health IT is released or marketed for purposes other than product development and testing, and subject to the permitted prohibitions and restrictions described in paragraph (a)(2)(ii) of this section, prohibit or restrict communications about matters enumerated in paragraph (a)(1) of this section.

(ii) For communications about one or more of the subject matters enumerated in paragraph (a)(1) of this section that is not entitled to unqualified protection under paragraph (a)(2)(i) of this section, a health IT developer may prohibit or restrict communications only as expressly permitted by paragraphs (a)(2)(ii)(A) through (E) of this section.

(A) (1) A health IT developer may prohibit or restrict the communications of the developer's employees or contractors.

(2) A self-developer must not prohibit or restrict communications of users of their health IT who are also employees or contractors.

(B) A health IT developer may prohibit or restrict communications that disclose information about non-user-facing aspects of the developer's health IT.

(C) A health IT developer may prohibit or restrict communications that involve the use or disclosure of intellectual property existing in the developer's health IT (including third-party intellectual property), provided that any prohibition or restriction imposed by a developer must be no broader than necessary to protect the developer's legitimate intellectual property interests and consistent with all other requirements of paragraph (a)(2)(ii) of this section. A restriction or prohibition is deemed broader than necessary and inconsistent with the requirements of paragraph (a)(2)(ii) of this section if it would restrict or preclude a public display of a portion of a work subject to copyright protection (without regard to whether the copyright is registered) that would reasonably constitute a “fair use” of that work.

(D) A health IT developer may require persons who communicate screenshots or video to—

(1) Not alter the screenshots or video, except to annotate the screenshots or video or resize the screenshots or video;

(2) Limit the sharing of screenshots to the relevant number of screenshots needed to communicate about the health IT regarding one or more of the six subject areas in paragraph (a)(1) of this section; and

(3) Limit the sharing of video to:

(i) The relevant amount of video needed to communicate about the health IT regarding one or more of the six subject areas in paragraph (a)(1) of this section; and

(ii) Only videos that address temporal matters that cannot be communicated through screenshots or other forms of communication.

(E) A health IT developer may prohibit or restrict communications that disclose information or knowledge solely acquired in the course of participating in pre-market product development and testing activities carried out for the benefit of the developer or for the joint benefit of the developer and communicator. A developer must not, once the subject health IT is released or marketed for purposes other than product development and testing, and subject to the permitted prohibitions and restrictions described in paragraph (a)(2)(ii) of this section, prohibit or restrict communications about matters enumerated in paragraph (a)(1) of this section.

(ii) For communications about one or more of the subject matters enumerated in paragraph (a)(1) of this section that is not entitled to unqualified protection under paragraph (a)(2)(i) of this section, a health IT developer may prohibit or restrict communications only as expressly permitted by paragraphs (a)(2)(ii)(A) through (E) of this section.

(A) (1) A health IT developer may prohibit or restrict the communications of the developer's employees or contractors.

(2) A self-developer must not prohibit or restrict communications of users of their health IT who are also employees or contractors.

(B) A health IT developer may prohibit or restrict communications that disclose information about non-user-facing aspects of the developer's health IT.

(C) A health IT developer may prohibit or restrict communications that involve the use or disclosure of intellectual property existing in the developer's health IT (including third-party intellectual property), provided that any prohibition or restriction imposed by a developer must be no broader than necessary to protect the developer's legitimate intellectual property interests and consistent with all other requirements of paragraph (a)(2)(ii) of this section. A restriction or prohibition is deemed broader than necessary and inconsistent with the requirements of paragraph (a)(2)(ii) of this section if it would restrict or preclude a public display of a portion of a work subject to copyright protection (without regard to whether the copyright is registered) that would reasonably constitute a “fair use” of that work.

(D) A health IT developer may require persons who communicate screenshots or video to—

(1) Not alter the screenshots or video, except to annotate the screenshots or video or resize the screenshots or video;

(2) Limit the sharing of screenshots to the relevant number of screenshots needed to communicate about the health IT regarding one or more of the six subject areas in paragraph (a)(1) of this section; and

(3) Limit the sharing of video to:

(i) The relevant amount of video needed to communicate about the health IT regarding one or more of the six subject areas in paragraph (a)(1) of this section; and

(ii) Only videos that address temporal matters that cannot be communicated through screenshots or other forms of communication.

(E) A health IT developer may prohibit or restrict communications that disclose information or knowledge solely acquired in the course of participating in pre-market product development and testing activities carried out for the benefit of the developer or for the joint benefit of the developer and communicator. A developer must not, once the subject health IT is released or marketed for purposes other than product development and testing, and subject to the permitted prohibitions and restrictions described in paragraph (a)(2)(ii) of this section, prohibit or restrict communications about matters enumerated in paragraph (a)(1) of this section.