The new regulations extend the donation period to December 31, 2016, and require that the donated technology be certified by a certifying body authorized by the National Coordinator of Health Information Technology.  Additionally, because both editions of certification criteria require e-prescribing functionality, the requirement that the donated electronic health record have e-prescribing functionality has been removed as a condition of the donation.

The regulations can be viewed at:

• http://www.ofr.gov/OFRUpload/OFRData/2013-08312_PI.pdf
• http://www.ofr.gov/OFRUpload/OFRData/2013-08314_PI.pdf

Should you have any questions, please contact Jeff Short at 317-977-1413 or jshort@hallrender.com.

Beginning in 2014, the CQM specifications will be used for multiple programs such as the Physician Quality Reporting Program, as a result of efforts to align incentive programs and reduce the burden on providers to report quality measures.

The updates to the electronic specifications of the CQMs finalized in the Stage 2 rule include new codes and logic corrections and clarifications. While CMS strongly encourages the implementation and use of the updates, CMS will accept all versions of the CQMs for MU, beginning with those finalized in the December 4, 2012 CMS-ONC Interim Final Rule and including all annual updates until the Stage 3 rulemaking and the establishment of a new edition of certification criteria for EHR technology.

The updated 2014 CQMs for eligible hospitals and corresponding specifications for electronic reporting and access to the related data elements and value sets are available here: 2014 specifications on the CMS website

Certification of EHR technologies requires that EHR software products and EHR modules be tested, as applicable, for their capabilities to accurately capture, calculate and report the Clinical Quality Measure results. Cypress is the official ONC Certification Program tool for testing these capabilities. The tool has encoded the measure logic required for testing a software implementation and updated test decks, which reflect updated quality measures. You can access the Cypress tool here: Cypress

If you have any questions regarding the Meaningful Use Stage 2, please contact Alisa Kuehn at akuehn@hallrender.com or (317) 977-1475.

Click here for more information and procedures for comment submission.

Should you have questions, please contact Alisa Kuehn at akuehn@hallrender.com or (317) 977-1475.

• Click here for information on attestation, tipsheets, FAQs, tools and regulations related to Meaningful Use Stage 2.
• Click here to access the 2014 Edition Test Method for Certification of EHR technology.
• Click here for Interoperability training courses that have been developed around the Stage 2 Meaningful Use Rule to train Eligible Professionals and Critical Access Hospitals how to implement the new standards.

For more information on Meaningful Use Stage 2, contact Alisa Kuehn at akuehn@hallrender.com or (317) 977-1475.

The FTC’s previous guidance on disclosures was issued seven years before Apple introduced the iPhone, long before the proliferation of Twitter, Facebook and other social networking and media platforms and before sponsors commonly compensated the sources of endorsements made on those platforms.  The FTC expects advertisers to follow the revised guidelines immediately.

The new guidance states that online disclosures must be clear and conspicuous, despite challenges related to social media and use of small screen mobile devices.  It also incorporates the FTC’s 2009 “Guides Concerning the Use of Endorsements and Testimonials in Advertising,” which requires a person speaking on behalf of a company to clearly state any relationship with a brand and whether they have received compensation.

If a particular platform does not provide an opportunity to make these clear and conspicuous disclosures, then that platform should not be used to disseminate advertisements that require disclosures.

The FTC provides several examples of compliant advertisements.  One example attempts to provide necessary disclosures for a weight-loss pharmaceutical product advertisement within a 140-character Twitter post.  In the Twitter example, a compliant disclosure might state that the weight-loss claim is not typical.  The advertiser could also make the hypothetical sponsored tweet compliant by starting the content with “Ad” and by including a disclaimer at the end, such as “Typical loss: 1lb/wk.”

Disclosures must be placed on a webpage in such a way that readers are aware of them before being distracted by other design elements.  For example, the guidelines describe a hypothetical example of a blogger putting a disclosure that she reviewed a product received for free at the bottom of the page, away from the text of the endorsement, and after several hyperlinks to unrelated information.  In that scenario, FTC said the placement “could distract readers and cause them to click away before they get to the end of the post.”

Disclosures that are an integral part of a claim must be placed on the same page and immediately next to the claim and be sufficiently prominent so that the claim and the disclosure are read at the same time.  It is not sufficient to refer the consumer somewhere else on the page, such as through scrolling, or to a separate webpage to obtain the information.  This is particularly true for disclosures about cost, health and safety.

In a limited number of scenarios not involving health, safety or cost, advertisers may place disclosures on a secondary website. However, this approach is additionally limited to those situations when the product for sale is only available from the advertiser and the potential customer has no choice but to view the disclosures on the advertiser’s landing page before placing an order.  If the reader could easily go to a different entity’s website to buy the recommended product, then the disclosures must be part of the original advertisement.

Industries also regulated by the Food and Drug Administration (“FDA”) are already familiar with the challenges of providing both disclosures and advertisement within size-restricted spaces.  In 2009, the FDA issued untitled warning letters to 14 of the world’s largest pharmaceutical companies for not including fair and balanced risk information in small text ads on Google and other search engines.  The FDA’s investigation into Google went even farther, accusing the company of using its AdWords platform for drug advertisements that were illegal.  Now Google AdWords restricts the promotion of health care-related services and products, including online pharmacies, prescription drugs, medical devices, dietary supplements, clinical trial recruitment and certain in vitro diagnostic tests.  In 2012, Google even complied with an FDA request to completely disable the AdWords accounts of nutritional supplement companies offering “detox” or “chelation” nutritional products as the agency believes such claims to be baseless, misleading and potentially dangerous to health.

Practical Takeaways

The FTC Act’s prohibition on “unfair or deceptive acts or practices” broadly covers all advertising claims, marketing and promotional activities and sales practices. The Act is not limited to any particular medium or industry.

In order to make a disclosure clear and conspicuous, advertisers should:

• Place the disclosure as close as possible to the triggering claim.
• Take account of the various devices and platforms consumers may use to view advertising and any corresponding disclosure.
• When a space-constrained ad requires a disclosure, incorporate the disclosure into the ad.
• Design advertisements so that “scrolling” is not necessary in order to find a disclosure. When scrolling is necessary, use text or visual cues to encourage consumers to scroll to view the disclosure.
• Display disclosures before consumers make a decision to buy — e.g., before they “add to shopping cart.”
• Repeat disclosures, as needed, on lengthy websites and in connection with repeated claims.
• If a product or service promoted online can be purchased from “brick and mortar” stores or from online retailers other than the advertiser itself, then any disclosure necessary to prevent deception or unfair injury should be presented in the ad itself — that is, before consumers head to a store or some other online retailer.
• Necessary disclosures should not be relegated to “terms of use” and similar contractual agreements.
• Prominently display disclosures so they are noticeable to consumers, and evaluate the size, color and graphic treatment of the disclosure in relation to other parts of the webpage.
• Review the entire ad to assess whether the disclosure is effective in light of other elements — text, graphics, hyperlinks or sound — that might distract consumers’ attention from the disclosure.
• Use audio disclosures when making audio claims, and present them in a volume and cadence so that consumers can hear and understand them.
• Use plain language and syntax so that consumers understand the disclosures.

If you have questions about the FTC’s, FDA’s or other agencies’ regulation of advertising, please contact Mark Dahlby at 414-721-0902 or mdahlby@hallrender.com or your regular Hall Render attorney.

If you have any questions regarding the Healthcare Connect Fund, the Telecommunications Program or communications infrastructure, please contact Michael T. Batt at 317.977.1417 or mbatt@hallrender.com or William A. Dummett at 317.977.1427 or wdummett@hallrender.com.

The Stark Law exception and anti-kickback statute safe harbor for EHR donations permitted certain health care providers to make a donation of up to 85% of the cost of an EHR to other health care providers.  The donations were permitted so long as the donor and recipient complied with the requirements of the regulations.  These requirements included a written donation agreement, recipient not already possessing equivalent technology and the donation not being tied to the volume or value of referrals from the recipient to the donor.

Should you have any questions, please contact Jeff Short at 317-977-1413 or jshort@hallrender.com.

The first publication, titled “Mobile Privacy Disclosures: Building Trust Through Transparency,” recommends ways to inform consumers about data collection and use practices.

Recommendations for operating systems providers include:

• Providing just-in-time disclosures and obtaining affirmative express consent before allowing apps to access consumers’ sensitive content;
• Considering a one-stop “dashboard” approach to allow consumer review of the types of content accessed by downloaded apps;
• Considering icons to depict the transmission of user data;
• Promoting app developer best practices, such as privacy disclosures; and
• Considering a Do Not Track (DNT) mechanism for smartphone users.

App developers should:

• Have an easily accessible privacy policy;
• Provide just-in-time disclosures and obtain affirmative express consent before collecting and sharing sensitive information;
• Improve coordination and communication with ad networks and other third parties that provide services for apps; and
• Consider participating in self-regulatory programs, trade associations and industry organizations.

The FTC also published “Mobile App Developers: Start with Security.”  In the guide, the agency says it expects mobile application developers to adopt and maintain reasonable data security practices but recognizes there is no one checklist for securing all apps.  Tips for mobile app security offered by the agency include:

• Make someone responsible for security;
• Take stock of the data collected and retained;
• Understand differences between mobile platforms;
• Don’t rely on a platform alone to protect users;
• Generate credentials securely;
• Use transit encryption for usernames, passwords and other important data;
• Use due diligence on libraries and other third-party code;
• Consider protecting data stored on a user’s device;
• Protect servers;
• Don’t store passwords in plaintext; and
• Understand applicable standards and regulations when dealing with financial, health or kids’ data.

If you have questions about privacy and security practices for mobile devices and other health information technology products, please contact Jeffrey W. Short at jshort@hallrender.com (317-977-1413), Mark T. Garsombke at mgarsombke@hallrender.com (414-721-0907), Melissa L. Markey at mmarkey@hallrender.com (248-457-7853) or Mark R. Dahlby at mdahlby@hallrender.com (414-721-0902).

The 2013 list, in order of ranking, is as follows:

1. Alarm hazards
2. Medication administration errors using infusion pumps
3. Unnecessary exposures and radiation burns from diagnostic radiology procedures
4. Patient/data mismatches in EHRs and other health IT systems
5. Interoperability failures with medical devices and health IT systems
6. Air embolism hazards
7. Inattention to the needs of pediatric patients when using “adult” technologies
8. Inadequate reprocessing of endoscopic devices and surgical instruments
9. Caregiver distractions from smartphones and other mobile devices
10. Surgical fires

The Institute says the list is designed to raise awareness of the potential dangers associated with the use of medical devices and systems and to help health care providers prioritize their technology safety initiatives. The list includes actionable recommendations for addressing each hazard.

If you have questions about the risk profiles of medical devices or other technology, please contact Mark R. Dahlby at mdahlby@hallrender.com or 414-721-0902.

To develop the original test method, NIST conducted an analysis of the HHS/ONC Interim Final Rule (IFR) published in the Federal Register on January 13,2010, including:

• The functional and interoperable requirements
• The referenced standards
• The test procedures that could be used to validate conformance with the derived test requirements
• The assumptions that may influence the selection of a specific test method or the scope of testing

The 2014 Edition Test Method was formally approved on December 14, 2012 by the National Coordinator and is now effective for use in ONC HIT Certification Program (formerly known as the Permanent Certification Program).  The 2014 Edition Test Method is now available (2014 Edition Test Method) and specific Test Data is available by selecting the corresponding link in the chart.  If there is no Test Data link, the Test Data are either not required or supplied by the vendor.

NIST has provided tools to test compliance with the meaningful use technical requirements and standards for Stage 2.  These tests are available here: NIST 2014 Meaningful Use Test Tools

More information on Meaningful Use State 2 is available here: Meaningful Use Stage 2.

If you have any questions regarding the Meaningful Use Stage 2, please contact Alisa C. Kuehn at 317.977.1475 or akuehn@hallrender.com.