Phillip A. McAfee is an attorney with a Masters Degree in Health Law from Loyola University in Chicago. He is also the owner of the Health Hippo Web site, which has provided deep and extensive links to government documents related to health law, policy and regulation since 1996.

The internet is a near perfect vehicle for the rule making process. Currently in the experimental stages, agencies in both state and federal government can notify interested parties, publish proposed rules, receive comments and publish final rules over the internet. Electronic rule making obviously holds great promise for open government.

The process of rule making under the Administrative Procedure Act begins with the publication of the Proposed Rule in the Federal Register (also called the “Notice of Proposed Rulemaking” or “NPRM”). Following the NPRM is a period for public comments, usually limited to 60 days. During this time the public is invited to raise issues and questions about the rule. The agency reviews the substance of the comments without regard to who offers them. All comments are made available for public inspection during the comment period and after the comment period has ended. Comments are analyzed and responses are prepared by members of the rule’s implementation team. The final rule is then published in the Federal Register with a summary of the comments, responses to comments and any changes made to the rule as a result of the comments. See 5 U.S.C. §553 (the procedures are different for “Negotiated Rulemaking”, see 5 U.S.C. §§561-570).

This article will describe and critique the process of electronic rule making (“ERM”), using the U.S. Department of Health and Human Services (HHS) rulemaking process under the Administrative Simplification provisions of the Health Insurance Portability and Accountability Act (HIPAA) as an example. In doing so, the reader will learn about the processes of creating large hypertext documents, broadcast list servers and automated email response systems. The article will also touch on the need to avoid the use of proprietary formats for government internet documents. Finally, the article provides a comparison table of other U.S. Government agency electronic rulemaking efforts and related references.

It should be noted that this article provides links to a hypertext version of HIPAA on the author’s Health Hippo web site that is not an official version of the law, a problem which is discussed further in Section III of this paper. The official version of HIPAA is in the printed U.S. Code and a semi-official (but difficult to use) electronic version may be found in the Government Printing Office (GPO) public law database at the following URL:

http://www.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=104_cong_public_laws&docid=f:publ191.104

I. Introduction to the HHS Administrative Simplification Rules

There are currently five moderately large rules offered by HHS to implement the administrative simplification provisions of HIPAA: 1) National Standard Health Care Provider Identifier; 2) Standards for Electronic Transactions and Code Sets; 3) National Standard for Identifiers of Health Plans; 4) National Standard Employer Identifier, and; 5) Security and Electronic Signature Standards. While the history and politics of these rules are beyond of the scope of this article, they are a good choice for an experiment in electronic rulemaking because they involve standards for transmission of data over the internet and are controversial enough to generate a fairly large response from an internet literate audience. Comments on all of these rules are also being accepted through the mail.

The first thing you will notice when visiting the HHS Administrative Simplification pages is the low graphics nature of the pages themselves. They load quickly and provided the information sought in straight forward and easy to use fashion. Attempts to create graphical user interfaces (GUIs) and the use of image maps on government web sites, while understandable as a form of expression for those who suffered long under DOS, Unix and early Windows platforms, often result in lower accessibility to government documents by creating a bandwidth barrier to the information (i.e., the pages load to slowly). Generally, visitors to government sites aren’t there to look at the pictures.

II. Providing Electronic Notice of Proposed Rules: Broadcast List Servers and Logical META Tags

Email notification of agency rules is an example of a great low-tech service that could easily be implemented government-wide. Once users are aware of the list server and subscribed, they receive email messages notifying them of proposed rules, comment periods and the publication of final rules. The use of an automated list server results in little or no administrative time being spent by the government to provide this service — other than time to set up the list and upload the various notices. Lists could be divided by agency or even divisions to provide users with notice that is targeted to their interests. As noted in the comparison table below, list servers are currently grossly underutilized in providing agency notice to citizens over the internet.

A list server is a computer program that distributes email to a large number of people who are subscribers to the list. When somebody sends an email message to the list address, the server picks up the message and sends it to all members of the list. Anyone who has ever subscribed to a list server understands that the list is administered solely by a computer and messages to the list itself must be segregated from commands to the list server, which go to a separate email address. Most list servers allow users to subscribe, unsubscribe and execute other commands that result in automated responses by sending email to the list server address.

List servers come in at least four flavors: 1) open discussion lists; 2) subscriber-only lists; 3) moderated lists and; 4) broadcast (read-only) lists. Open discussion lists (which allow anyone to post) and subscriber lists (which allow any subscriber to post) are probably of little use in the standard electronic rule making process. The subject matter and the audience make it unlikely that entertaining chat room style discussions of rules would ensue from people with interesting user names (pachyderms excluded). Such discussions are certainly not required under the Administrative Procedure Act and would make it difficult for the rule implementation team to determine when a person actually desired to make an “official” comment on a rule. There may, however, be some applications for the first two types of lists in the negotiated rule making process cited above. A moderated discussion list simply routes mail to the list owner, who may then edit or delete messages prior to sending them back out to the group or posting them elsewhere (e.g., on the web). One problem to keep in mind with moderated lists is that some person (i.e., the moderator) is placed in the capacity of censoring comments sent by others that were intended for the consumption of the group.

Broadcast or read-only lists only allow posts to the list members from the list owner and thus work well for providing notice of proposed rules, press releases and the like. HHS provides two examples of this elegant technology in action. First, the Department has a broadcast list for its press releases, which can be subscribed to through an internet interface. A second broadcast list is provided by the Department’s Administrative Simplification web site with the narrow function of providing notice of proposed and final rules relating to the administrative simplification sections of the Health Insurance Portability and Accountability Act. The second list, broadly entitled HIPAA-REGS, may be subscribed to by following instructions at the HHS Administrative Simplification web site.

Both of the HHS efforts to inform the public are commendable, but could be improved. For example, a person who subscribes to HHS press releases list should have confidence that notice of all HHS proposed rules will be provided through that list. This has not been the case. Setting up separate list servers with narrow functions seems redundant and could lead to confusion and complaints from those who are not privy to the lists’ existence. Although there is presently no clear duty to provide other than Federal Register notice of proposed rules, agencies may be but a liberal interpretation of the Electronic Freedom of Information Act Amendments away from having to provide electronic notice, which is a predicate to electronically accessing time-sensitive documents such as proposed rules.

The title of the HHS Administrative Simplification list (HIPAA-REGS) also creates confusion. While the title “Administrative Simplification” may itself be a misnomer for a statute creating long and complicated code sets (see e.g., Warning: the Electronic Data Interchange Implementation Guide is 3,600 pages long, takes 2 hours to download and 8 hours to print), that is the language someone interested in the rule would search on. HIPAA, as noted above, is an acronym for the Health Insurance Portability and Accountability Act, a 73,000 word law of which the Administrative Simplification provisions are only a small part. Many HHS regulations coming out under HIPAA are not currently announced by either the HIPAA-REGS or the HHS Press Release lists.

A final method of broadcasting notice of government rules and other activities does not involve the use of email at all. Instead it relies on the ability of internet search engines or “spiders” to find web sites and rank them high in the search results of users. I took the liberty of running the HHS Administrative Simplification site through Earthlink’s excellent Website Garage — a free tool for diagnosing a web site’s effectiveness. Though the site did well in most categories, it ranked “poor” in optimization for search engine registration largely due to the fact that the pages contain no META tags at all. These tags (which are basically hidden key words) are critical to a search engine’s ranking of a web site in its results and, consequently, a user’s ability to find the site. META tags must be formatted with assistance from someone who knows the subject matter of the site (in this case, the various rules) to be most effective. There is no reason the government should not promote access to laws and services through META tags with the same vigor as private commercial enterprises.

III. Official and Unofficial Versions of Proposed and Final Rules

The HHS Administrative Simplification site provides links to Federal Register Notice related to several proposed rules under HIPAA. You do have to drill down three screens to get to them, but the hierarchical layout of the site is logical. Once you reach the screen with the links themselves, you are treated to a deep link to the GPO version of the rule and a separate but identical version housed on the HHS server.

The deep links to proposed rules in GPO’s electronic version of the Federal Register suffer from UNIX-based text formatting. Rather than soft-wrapped text that neatly resizes to fill any browser window, each line of text ends abruptly with a carriage return. Such returns (also called “hard returns”) represent permanent instructions for the computer to end the line at the point of the return symbol. Hard returns make it difficult to view documents and cut and paste text into other documents. They can be corrected by automatically replacing each single return with a space through a word processor’s search and replace feature, after replacing each double return with some other character. GPO versions of all documents present other formatting challenges, including: “dumb” quotation marks, non-tabulated indents, and unnecessary capitalization.

The HHS decision to carry an identical version of the GPO rule on its server, while addressing the remote possibility that one server would become inundated with requests or become otherwise incapacitated, misses an important opportunity to provide reader service. For example, by creating an “unofficial” version of the proposed rule Standards for Electronic Transactions and Code Sets (which is over 330 kilobytes in size) hard returns could have been removed and other peculiar GPO formats corrected, thereby dramatically improving the readability of the document. HHS could also have created a hypertext (i.e., linked) index to the rule’s various parts — splitting the giant document into smaller, easy to use chunks. An advanced hypertext version could even provide additional links to outside documents cited in the proposed rule and the ability to comment directly from the various sections of the rule. All of this could be covered in the preamble to the rule by simply stating that the hypertext version was not official and was provided as a reader service.

The electronic version of the proposed rule on GPO’s server is currently no more official than the version on the HHS server. The only truly official version of a proposed rule resides in print in the Federal Register. With all electronic versions being equally “unofficial” it makes little sense not to provide some reader services in the agency presentation of the rule. After the comment period passes, the HTML version could be replaced by a permanent plain text version (hopefully absent the formatting idiosyncrasies of the GPO version). As noted above, the time it would take to do this is minimal. The formatting time would be substantially lessened or eliminated if the GPO could be convinced to provide modern text formatting of its documents from the outset.

IV. Proprietary Formats Do Not Create Official Electronic Documents

HHS also provides links to the various proposed rules in portable document format (.pdf — a proprietary document formatting product from Adobe Systems). Portable document format preserves a document’s formatting at the great expense of large file sizes and diminshed ability to search, print, copy, paste and edit text. Electronic versions of proposed rules in PDF format are no more official than plain text or HTML versions and place the additional barrier of downloading (and then using) Adobe’s Acrobat Reader between the user and the information sought. In addition, the files are unreadable by Lynx browsers used by the blind, thereby creating ADA concerns. The PDF routine of bypassing the browser to directly access the user’s hard drive and store the document prior to any review of the material is offensive to many people’s notion of security and privacy. Non-proprietary image formats such as GIF and JPG embedded in HTML documents would be much preferable for graphical portions of rules that can not otherwise be presented.

It is particularly disturbing to find electronic documents available only in PDF format (or other proprietary formats such as ZIP, WP and WORD) and such documents are linked to the Administrative Simplification page through the Washington Publishing Company’s Implementation Guides and Data Dictionaries for Transaction Standards. The front page of Washington Publishing’s site includes a registration process with the only apparent purpose of creating an additional barrier to get to the PDF documents. Ironically, a user may bypass the registration entirely by following this link directly to the broadly entitled HIPAA Download Page. All of the warnings about download and print times, the use of PDF format and the “registration” process are perhaps designed to make the user abandon any attempt at downloading the Guides and just purchase paper copies or a CD from Washington Publishing Company. The company provides a link to an easy to use order form and an 800 number on each page.

V. Soliciting Email Comments

The HHS system of accepting email comments tagged with the section of the rule is sound, but the solicitation of comments suffers from a lack of interactivity with the rules themselves. A user would be much more likely to offer comments electronically, for example, were it possible to do so directly from the pages of the rule he or she wished to comment on. Otherwise even a internet expert is faced with the prospect of opening a link to a poorly formatted and very long proposed rule, printing or reading the rule online (while their link to the internet goes dead) and then, after noting the section of the rule they wish to comment on, reconnecting and opening the appropriate mail link before commenting. This seems like a bleak prospect to save a 32 cent stamp.

The current reality of comments on proposed rules, however, is that they are not made casually. Most comments come from highly self-interested parties and are made by lawyers or lobbyists after consultation with and approval of clients, boards, associations and other large organizations. These comments are carefully drafted and redrafted after meticulous dissection of the rules.

Though at first blush it would seem to make little difference whether these comments were mailed or submitted electronically, perhaps the real promise of electronic rule making lies in the ability to access such comments (both paper and electronic) for inspection in advance of the publication of a final rule. In this way, common citizens (i.e., those who don’t subscribe to the Federal Register) gain access to a process that is often unintentionally hidden from them and results in interesting banter between well-represented special interests and government agencies that “know what’s best.” Input from the casual citizenry would no doubt freshen the rule making process considerably and ought to be solicited through easy interfaces and logically searchable terms (including META tags).

VI. Conclusion

Regardless of the actual number of people who comment on the HHS Administrative Simplification rules electronically, it would be unfair to judge this innovative and evolving experiment on the basis of just one of its components. The internet is embryonic in the context of human communication, with HTML and email protocols changing rapidly to make the prospects of electronic rule making both promising and inevitable. Turnover in a work force and power structure that is largely internet illiterate will make electronic rule making the standard in coming years. And finally, the value of posting notices, proposed rules and comments that may be easily found and accessed by those previously divorced from the process is already evident.

Notes:

A. Table: Electronic Rule Making Compared

Agency	List server Notice	Rule Text*	Submit Comments	View Comments	Barriers to Access**	Rules Included
1. USDA APHIS Online Comment Facility	n/a	summary, plain HTML, PDF, GPO link	via interactive form	yes, only comments received electronically	none	selected rule
2. USDA National Organic Program Rules	n/a	PDF, plain & hypertext HTML	unknown	yes, searchable	requires TIFF viewer for some comments, registration	selected rule
3. Commerce Technical Management of Internet Names and Addresses	n/a	plain and enhanced HTML	via untagged email	yes, by date received and mode of transmission	none	selected rule
4. BLM Regulatory Actions	none	plain HTML	via untagged email	none	none	BLM-wide
5. HHS: Administration for Children & Families	none	plain HTML w/ hypertext comments	via interactive forum	yes, via interactive forum	requires registration to comment	ACF-wide
6. DOT Docket Management System	none	abstracts, TIFF	none	yes, search by docket number or key word	requires TIFF viewer	plans to become DOT-wide
7. NRC RuleMaking Forum	none	WP, plain HTML	uploaded as files via interactive form	yes, only comments received electronically	comments require ability to upload files	NRC-wide

* Plain HTML is the equivalent of a text file, usually with all of the formatting idiosyncrasies of a GPO document. Enhanced HTML indicates that the rule has been enhanced visually, but does not contain hypertext links (usually in the form of a Table of Contents).

**The existence of proprietary formats is not considered a barrier unless no alternative exists for viewing documents.

1. A pilot project which will allow you to submit comments (and read submitted comments) on selected rules. This facility does NOT include postal or faxed comments submitted on the rules, only comments submitted electronically through the forms in the facility. Interactive form provided for licensing rule for dogs and cats, demonstrating the potential to boil rulemaking down to simple question and answer interfaces.

2. Includes links to HTML documents including the proposed rule, notices, comments received (searchable), transcripts and the ability to comment electronically — though a registration process was required. The comment period closed April 30, 1998.

3. March 23, 1998 was the official deadline for the acceptance of public comment on this proposed rule. All messages received at [email protected], messages sent directly to government officials that comment on the substance of the proposed rule, scanned versions of comments received as hard copy, and comments recived late, will be published here. Does not provide comments by section or topic,.

4. BLM has opted for a simple ERM system that includes full HTML text of the rules. To comment, just send email with the regulation identified in the subject line. Comments are not available online

5. From this page, individuals may submit comments that address an entire proposed rule or are targeted to specific sections. You can also see comments submitted by others and comment on those if you wish. Includes links to HTML versions of the rules.

6. This electronic docket system is both ambitious and confusing, requiring a graphic TIFF viewer to see documents. Does not support a text search or structured search by regulatory sections.

7. Covers multiple rules of the NRC, providing background, current news, rule text and related documents, public and state comments, contact information and the ability to comment electronically. All documents are available in HTML.

B. Related References:

• Electronic Rulemaking: Outline of Opportunities and Issues (Walton Francis, May 1997) The several agencies that have tried ERM–such as the Animal and Plant Health Inspection Service at USDA–have had mildly positive experiences. The main complaint at these agencies has been that very few members of the public have responded to ERM requests. Operational problems have been few and solved quickly. However, no agency has yet used a full ERM system–including both internal and external review–on a complex rule generating large numbers of comments. Thus, large scale operational experience remains to be obtained.
• Electronic Dockets: Use of Information Technology in Rulemaking and Adjudication (Report to the Administrative Conference of the United States, Henry H. Perritt, Jr., September 1995) Introducing some of the basic technologies and explaining how new developments in open networking technology significantly expand the range of choices available to agencies like DOT and NRC. Then the report focuses specifically on the two agencies, explaining their initiatives. It considers the policy and legal questions confronting these and other agencies who automate their regulatory proceedings.
• Notes on Electronic Government (Henry H. Perritt, Jr, May 1994) The time is right for further explicit demonstration of electronic rulemaking, electronic adjudication, and the use of electronic mail for informal interaction between government decision makers and affected citizens. These demonstrations need to be highly visible so that agencies with rulemaking authority, congressional bodies, courts, and adjudicatory hearing officers and the participants in these governmental processes can take full advantage of information technology. There are no significant legal or policy impediments to immediate implementation of available technology.