Roopen Patel
7/18/11
Week 2 Homework Help – GM520.
Here is an example to get you started on the Week 2 Homework:
1. State the administrative agency which controls the regulation. Explain why this agency and your proposed regulation interests you (briefly). Will this proposed regulation affect you or the business in which you are working? If so, how? Submit a copy of the proposed regulation along with your responses to these five questions. The proposed regulation can be submitted as either a separate Word document (.doc) or Adobe file (.pdf). This means you will submit two attachments to the Week 2 Dropbox: (1) a Word doc with the questions and your answers and (2) a copy of the proposed regulation you used for this assignment. (10 points)
Department of Health and Human Services- Since I work in the healthcare field and use Electronic Health Records documenting patients medical history, diagnoses, and treatment.

http://www.regulations.gov/#!documentDetail;D=HHS-OCR-2011-0011-0001
2. Describe the proposal/change. (10 points)
A Notice of Proposed Rulemaking concerning the accounting of disclosures requirement under the Health Insurance Portability and Accountability Act (HIPAA) Privacy Rule. The proposed rule would give people the right to get a report on who has electronically accessed their protected health information.
The U.S. Department of Health and Human Services’ (HHS) Office for Civil Rights (OCR) is proposing changes to the Privacy Rule, pursuant to the Health Information Technology for Economic and Clinical Health (HITECH) Act. HITECH is part of the American Recovery and Reinvestment Act of 2009.
People would obtain this information by requesting an access report, which would document the particular persons who electronically accessed and viewed their protected health information. Although “covered entities” are currently required by the HIPAA Security Rule to track access to electronic protected health information, they are not required to share this information with people.
The proposed rule requires an accounting of more detailed information for certain disclosures that are most likely to affect a person’s rights or interests. The proposed changes to the accounting requirements provide information of value to individuals while placing a reasonable burden on covered entities and business associates.
3. Write the public comment which you would submit to this proposal. If the proposed regulation deadline has already passed, write the comment you would have submitted. Explain briefly what you wish to accomplish with your comment. (10 points)
I am writing to support the proposed regulation because it would make healthcare facilities accountable for my private health information. I believe it will also force them to ensure security of my information and prevent breach. Like one’s credit report, I believe a person’s health information accessibility history should be tracked and report generated upon request.
4. Provide the "deadline" by which the public comment must be made. (If the date has already passed, please provide when the deadline was). (5 points)
This expires on 8/2/11.
5. a. Once you have submitted your comment, what will you be legally entitled to do later in the promulgation process (if you should choose to do so)? (See the textbook's discussion of the Administrative Procedure Act.)
I would be able to challenge the validity of the rule in court. An administrative rule can be challenged on several different grounds. The first ground on which to challenge an agency rule is to determine if that rule is arbitrary, capricious, an abuse of discretion, or in violation of some other law. This is generally applied to formal rulemaking and simply requires the agency to show evidence to support the proposed rule.
b. If the proposal passes, identify and explain the five legal theories you could use in an attempt to have the regulation declared invalid and overturned in court.
1. The first legal theory for challenging an agency would be that the regulation is unsupported by substantial evidence. This substantial evidence test is applied in the review of formal and hybrid rulemaking. Where the arbitrary and capricious standard simply requires some proof or basis for the regulation, substantial evidence requires the more convincing evidence exist in support of the regulation than against it.
2. The next agency rule is the regulation is arbitrary, capricious, an abuse of discretion, or in violation of some other law. This standard is generally applied to informal rulemaking and simply requires the agency to show evidence to support the proposed rule. Without is evidence, the rule is arbitrary and capricious.
3. Another theory to challenge the agencies’ regulation involves the rule that a regulation can be set aside if the agency did not apply the APA requirements of notice, publication, and public comment or input. The procedures for rulemaking must be followed in order for the regulatory process and resulting rules to be valid. An agency that seeks public comment for the purposes of drafting legislation cannot then transform the legislation into rules after the comment period.
4. A fourth theory for a challenge is to state that the regulation is unconstitutional. Numerous challenges on constitutional grounds deal with regulation that gives an agency authority to search records or impose discriminatory requirements.
5. Lastly ultra vires meaning beyond its power. An Ultra vires regulation is one that goes beyond the authority given to the agency in its introduction of the act. Although most of the time agencies stay within their scope, if an agency tries to change the substance and purpose of the introduction, the regulation would be considered ultra virus
c. Which of these challenges would be the best way to challenge the regulation you selected for this assignment if you wanted to have the regulation overturned and why?
I believe the best way to challenge the rule would be by stating this new rule is arbitrary and cupreous. It is unsupported with sufficient evidence to prove its necessity. I would question the need for the change asking for substantial evidence that proves the change is necessary and that it will benefit the people. I would ask for proof that this change is necessary in the form of documented research stating that there is a benefit for a individual viewing their medical records access history. I also would ask for evidence that states an individual would want to access their medical record history. I believe the current, strict regulations on EHR’s are sufficient to protect a person’s health information. The change would require expensive additions(both software and hardware) to the healthcare facilities which may prove to be burden on smaller facilities.
Answer all of these questions for #5 even if you are in favor of your proposed regulation. The response to question 5 should be a minimum of 2-3 paragraphs long. (15 points)