Explosive growth in digital health over the last few years means there are many developers and managers who haven’t worked under HIPAA before. This guide is written for startups (and small businesses operating online) who could use some help with the basics of HIPAA compliance.
(a) The ALJ must conduct a fair and impartial hearing, avoid delay, maintain order, and ensure that a record of the proceeding is made.
(b) The ALJ may--
(1) Set and change the date, time and place of the hearing upon reasonable notice to the parties;
(2) Continue or recess the hearing in whole or in part for a reasonable period of time;
(3) Hold conferences to identify or simplify the issues, or to consider other matters that may aid in the expeditious disposition of the proceeding;
(4) Administer oaths and affirmations;
(5) Issue subpoenas requiring the attendance of witnesses at hearings and the production of documents at or in relation to hearings;
(6) Rule on motions and other procedural matters;
(7) Regulate the scope and timing of documentary discovery as permitted by this subpart;
(8) Regulate the course of the hearing and the conduct of representatives, parties, and witnesses;
(9) Examine witnesses;
(10) Receive, rule on, exclude, or limit evidence;
(11) Upon motion of a party, take official notice of facts;
(12) Conduct any conference, argument or hearing in person or, upon agreement of the parties, by telephone; and
(13) Upon motion of a party, decide cases, in whole or in part, by summary judgment where there is no disputed issue of material fact. A summary judgment decision constitutes a hearing on the record for the purposes of this subpart.
(c) The ALJ--
(1) May not find invalid or refuse to follow Federal statutes, regulations, or Secretarial delegations of authority and must give deference to published guidance to the extent not inconsistent with statute or regulation;
(2) May not enter an order in the nature of a directed verdict;
(3) May not compel settlement negotiations;
(4) May not enjoin any act of the Secretary; or
(5) May not review the exercise of discretion by the Secretary with respect to whether to grant an extension under § 160.410(b)(2)(ii)(B) or (c)(2)(ii) of this part or to provide technical assistance under 42 U.S.C. 1320d- 5(b)(2)(B).