At National Health IT Week Summit HHS Proposes New Rules to Give Patients Direct Access to Their Lab Reports

National Health IT WeekOn August 12, 2011, at an inaugural Summit for National Health IT Week, taking place August 11-16, 2011, the U.S. Department of Health & Human Services (HHS) announced proposed new rules that would allow patients for the first time to gain access to their lab reports directly from the labs.

The proposed new rules, under the Health Insurance Portability and Accountability Act of 1996 (HIPAA), would strengthen patients’ rights to access their own health records, by requiring labs covered by HIPAA to provide the patient’s own laboratory test result reports, upon request, directly to the patient or the patient’s personal representative.

“When it comes to health care, information is power. When patients have their lab results, they are more likely to ask the right questions, make better decisions and receive better care,” HHS Secretary Kathleen Sebelius said in a release about the new rules issued by HHS.

Other initiatives of National Health IT Week include the inaugural Consumer Health IT Summit, a new Personal Health Record (PHR) Model Privacy Notice Template provided by HHS, release of the new Federal Health IT Strategic Plan 2011 – 2015, and a Consumer e-Health Initiative, all described in this article.

National Health IT Week Initial Event: Consumer Health IT Summit

HHS announced the new rules at the opening of a Consumer Health IT Summit that took place via live webcast on August 12, and was sponsored by HHS as a kick-off event for National Health IT Week. According to HHS, the Summit was a first-ever event “which brought consumers, providers, and the public and private sectors together to discuss how best to empower consumers to be partners in their health and care through health IT.”

“This Summit offers a unique opportunity for the public and private sectors alike to share strategies to improve consumer access to their health information, while safeguarding the privacy and security of their data,” said Secretary Sebelius.

The Consumer Health IT Summit was the initial event of National Health IT Week, taking place August 11-16, 2011, which was declared by President Barack Obama as “a time to highlight the importance of efficient information systems that protect the privacy and security of personal health information while improving the delivery of health care in the United States.”

“I urge all Americans to learn more about the benefits of Health IT by visiting HealthIT.gov, take action to increase adoption and meaningful use of Health IT, and utilize the information Health IT provides to improve the quality, safety, and cost effectiveness of health care in the United States,” the Presidential Declaration said.

More information on National Health IT Week is provided at HealthIT.gov, a new website of the U.S. government, maintained by HHS.

The Proposed New Rules under HIPAA

The new rules, which propose to amend the Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations and HIPAA privacy regulations to strengthen patients’ rights to access their own laboratory test result reports, were proposed pursuant to a Notice of Proposed Rulemaking (NPRM), jointly drafted by the Centers for Medicare & Medicaid Services, the HHS Office for Civil Rights (OCR), and the Centers for Disease Control and Prevention (CDC).

More information about the proposed amendments to the CLIA and HIPAA Privacy regulations is provided by a Fact Sheet available on the website of the Centers for Medicare and Medicaid Services (CMS).

Secretary Sebelius also announced on August 12, the appointment of Leon Rodriguez to fill the position of Director of the HHS Office for Civil Rights (OCR). Mr. Rodriguez is an attorney whose experience includes practice at the U.S. Department of Justice.

Mr. Rodriguez said one of his priorities will be to ensure that consumers’ health information is kept private and secure. “The privacy and security of health data will be a top priority for OCR during my tenure,” he said. “Consumers need to know that private and secure access to their health information is a given.”

Other Initiatives of National Health IT Week

Personal Health Record (PHR) Model Privacy Notice Template. At the Health IT Summit on August 12, Secretary Sebelius also unveiled a new voluntary Personal Health Record (PHR) Model Privacy Notice, which, according to a HHS release, “creates an easy-to-read, standardized template allowing consumers to compare and make informed decisions based on their privacy and security policies and data practices about PHR [Personal Health Record] products.” “The new template is similar to the Nutrition Facts Labels in that it presents certain complex information in a simple way to improve transparency and consumer understanding about data practices,” HHS said. “By making this Model Privacy Notice available, PHR [Personal Health Record] companies can help build greater trust in PHRs.”

A copy of the Personal Health Record (PHR) Model Privacy Notice template, along with further information about its goals, how it was developed, and guidelines for PHR companies and for consumers on how to use it, can be found on HealthIT.hhs.gov, a site maintained by HHS.

Federal Health IT Strategic Plan 2011 – 2015. On August 12, 2011, the Office of the National Coordinator for Health Information Technology (ONC), part of HHS, published the final version of the Federal Health IT Strategic Plan 2011 – 2015 (the Plan). The Plan was last published in 2008, and, after a public comment process, has now “been updated to take into account the rapidly changing landscape of health IT and health IT policy,” according to a summary on the National Health IT Week site.

More detailed information about the Federal Health IT Strategic Plan 2011 – 2015 is provided on a website maintained by ONC/ HHS. This includes links to both an Overview of the Plan, and a copy of the Plan in its entirety.

In a blog post about the publication of the new Federal Health IT Strategic Plan, ONC said, “The Plan is meant to be a living document that will be updated based on experience with stage one of the meaningful use electronic health record (EHR) incentive programs and the results of our evaluation program.” “We will continue to track national progress toward achieving the goals laid out in this Plan, particularly the high-priority goal for providers to adopt and become meaningful users of certified EHR technology,” ONC said.

Further highlighting the objectives of the Plan, the ONC post states:

“We fully acknowledge the Plan is ambitious, but wholeheartedly believe that meaningful use of certified EHR technology provides the electronic infrastructure that is essential to support implementation of key delivery system transformations, like Accountable Care Organizations and Patient-Centered Medical Homes, and the priorities in the National Quality Strategy.”

“As technology improves more aspects of our daily lives, it makes sense to marry cutting-edge technology with our medical and personal health records so that we can improve both the quality and efficiency of the care that people receive,” said National Coordinator for Health Information Technology, Farzad Mostashari, M.D., Sc.M. “We are encouraging everyone to visit our website at www.HealthIT.gov to read our newly released Strategic Plan that sets forth our comprehensive plans for consumer empowerment for the next five years.“

Consumer e-Health Initiative. Leading up to events of National Health IT Week, the HHS Office of the National Coordinator for Health Information Technology (ONC) announced on August 8, 2011, that “ONC will soon be launching a Consumer e-Health Program to equip and empower individuals to be partners in their own health and health care through health IT.”

“We believe that health IT can play a critical role for you, just as it can for your doctors and other health care providers,” ONC said in a blog post announcing the initiative.

According to ONC, the Consumer e-Health Initiative will focus on the following 3 areas:

“1. Access

You need access to information if you are going to be a partner in your health. You already have a legal right to access your medical records. If your doctors and hospitals make your records easily and securely available electronically, it will make it easier for you to manage your health and share this information with others you trust to help coordinate your care. By looking at your own records, you can help identify and fix mistakes, and better understand what’s going on when you talk to a doctor, nurse, or other health care provider.

2. Action

Innovative tools and applications can help you take action with your health information, whether through your cell phone, smart phone, or programs that can help you set and meet your own health goals. We’re talking about everything from digital, wireless pedometers to text reminders. We’re also working to ensure that no populations are left behind or caught up in the “digital divide.”

3. Attitude

Traditionally, doctors gave instructions and patients followed their directions (or not). We want you to know that it’s OK to talk to your doctor, to ask questions, to share ideas, and to be a genuine partner in your care. Better access to information and the tools to use that information effectively should help you play a more engaged role in your health.”

ONC announced that it will be launching a public campaign about “Putting the I in Health IT,” which it said will “use[] stories to showcase how consumers and health care providers are partnering to use health IT to improve health and health care.”

Benefits of Health IT Listed at Consumer Health IT Summit

At the Consumer Health IT Summit on August 12, kicking off National Health IT Week, speakers listed benefits of electronic health records and health IT, including:

  • “Health IT empowers patients. For example, people at risk for heart attacks may use mobile health applications to manage their weight, diet, and medication adherence.
  • Health IT can facilitate lasting quality improvements, which can lead to greater efficiency and cost savings in the long-term.
  • Health IT is driving innovation in all parts of consumers’ lives – from new interactive applications to devices like digital pedometers and other devices that capture important health information from everyday experiences.
  • Health IT helps coordinate better care, and can be a powerful tool if you or a loved one is managing a serious medical condition.
  • Health IT has robust security and all users, from patients to caregivers to doctors, can easily and safely access and share health information electronically.
  • Health IT may help diagnose health problems sooner, avoid medical errors and provide safer care which can result in lower costs.”

More than 25 health care stakeholder organizations were represented at the Summit, including those representing consumers, large and small practice providers as well as insurers and health IT industry leaders. According to the HHS release, those who attended “pledged to empower consumers by making it easier for them to get secure access to their health information to engage more fully in their health.”

“We are at a critical moment in time when we can either choose to innovate, or lag behind in care,” said Dr. Mostashari, National Coordinator for Health Information Technology. “A commitment by health care stakeholders to support health IT and provide greater consumer access to their health information is the first step toward a healthier future.”

“In the coming year, ONC will work with health care stakeholders to further consumer access to information and empower consumers to become active participants in their health,” according to HHS.

More Information

The new HHS website, www.HealthIT.gov includes both consumer-oriented and health care provider-oriented information on the benefits of health IT, and health education materials focusing on new advances in health IT.

For more information on National Health IT Week, see National Health IT Week 2011, a page of the new HHS HealthIT.gov website.

See also the HelpingYouCare™ resource page on

Helpful Technology for Elder Needs

And see our reports on:

Americans Increasingly Find Health Information via Internet, CDC Reports

High-Tech Increasingly Used to Allow Seniors to Age in Place

A Free Online Application to Manage Health and

Study Finds Family Caregivers Want Web-Based and Mobile Technologies to Help Care for Senior Loved Ones

See also the HelpingYouCare™ resource pages on VoicesForCare™, including:

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Copyright © 2011 Care-Help LLC, publisher of HelpingYouCare™.

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