Apple v. Samsung: The Patent Trial of the Century

Tech Giants Near a Landmark Jury Trial Over iPhone and Android; Is it Innovation or Litigation?

By ASHBY JONES And JESSICA E. VASCELLARO Samsung Electronics Co. recently leapfrogged Apple Inc. AAPL as the world's largest seller of smartphones.

But whether Samsung got to the top legally or, as Apple claims, cheated its way there by ripping off the designs behind Apple's iPhone and iPad, is a question that jurors will decide in the kind of roll-the-dice trial that even the fiercest rivals typically try to avoid.

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1962 glass could be Corning's next bonanza seller

Sturdy Corning glass from 1962 could be a multibillion winner in frameless TV market

, On Sunday August 1, 2010, 2:14 pm EDT

CORNING, N.Y. (AP) -- An ultra-strong glass that has been looking for a purpose since its invention in 1962 is poised to become a multibillion-dollar bonanza for Corning Inc.

The 159-year-old glass pioneer is ramping up production of what it calls Gorilla glass, expecting it to be the hot new face of touch-screen tablets and high-end TVs.

Gorilla showed early promise in the '60s, but failed to find a commercial use, so it's been biding its time in a hilltop research lab for almost a half-century. It picked up its first customer in 2008 and has quickly become a $170 million a year business as a protective layer over the screens of 40 million-plus cell phones and other mobile devices.

Now, the latest trend in TVs could catapult it to a billion-dollar business: Frameless flat-screens that could be mistaken for chic glass artwork on a living-room wall.

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Riviera Distribs., Inc. v. Jones

Riviera came to the wrong forum. Agreements such as the one between Riviera and Midwest are designed to reduce the price tag of decision-making. By filing another suit, Riviera forced Midwest to bear the very expenses that the parties had agreed to avoid. The party responsible for creating excessive legal costs must bear them itself in the end.

This conclusion makes it unnecessary to discuss the parties’ other disputes, such as whether by filing a second suit Riviera entitled Midwest to an award under 28 U.S.C. §1927.

The judgment is reversed, and the case is remanded for an award of reasonable attorneys’ fees to Midwest under 17 U.S.C. §505. The award should include the legal fees that Midwest has incurred to vindicate its rights on appeal.

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How CCHIT Makes EMR Selection Easy

An integrated electronic medical record (EMR) system can improve your practices processes through increased efficiency, better E&M coding and reduced mistakes and insurance rejections. Once your practice has decided to make the switch to an EMR system, it is important to research the products thoroughly to make sure you select the right package for your practice.

With so many EMR products on the market – where do you start? You may be frustrated and confused by the EMR industry claims. It is hard to judge product stability, quality, interoperability, data portability and security. Fortunately, the Certification Commission for Healthcare Information Technology (CCHIT) has taken some of the guesswork out by creating a certification program for EMR products that places a “gold seal” on packages that make the grade. Currently 37 products have received the CCHIT product certification.

CCHIT works in collaboration with the American Health Information Community, the Department of Commerce’s National Institute of Standard and Technology, and with several other organizations awarded HHS contracts to harmonize standards, develop prototypes for national health information network architecture, and assess privacy and security laws and practices. The work of CCHIT has been endorsed by a number of physician professional organizations, including: The American Academy of Family Physicians, The American Academy of Pediatrics, The American College of Physicians, and Physicians’ Foundation for Health Systems Excellence & Physicians’ Foundation for Health Systems Innovation.

CCHIT Certification Process

The CCHIT certification process tests and inspects products on a comprehensive set of criteria for:

  • functionality (ability to create and manage electronic records for all patients, as well as automating workflow in a physician’s office),
  • interoperability (a first step in the ability to receive and send electronic data to other entities such as laboratories), and
  • security (ability to keep patients’ information safe).

Functionality

CCHIT certification for the functionality of an ambulatory EHR—its ability to carry out specific tasks—requires products to meet 263 criteria in 41 categories.

Security and Reliability

According to CCHIT, “An EMR must protect the privacy of patients’ health information while providing secure and reliable access for care providers.” To ensure data privacy and prevent data loss, CCHIT requires EMRs to meet 48 criteria in four security categories (access control, audit, authentication and technical services) and three reliability categories (backup/recovery, documentation and technical services).

Interoperability

The 27 CCHIT criteria governing certification requirements for interoperability - the ability to exchange data with other systems - require EHRs to be able to receive and transmit information in six categories:

  • Laboratory and imaging
  • Medications
  • Immunizations
  • Clinical documentation
  • Secondary uses of clinical data
  • Administrative and financial data

CCHIT’s certification compliance criteria and its design for a certification inspection process have been thoroughly researched, taking into account the state of the art of EMRs and available standards, and comparing certification processes in other industries and other countries. The inspection process is based on real-life medical scenarios designed to test products rigorously against the clinical needs of providers and the quality and safety needs of health care consumers and payers. One script, for example, recreates a scenario of an elderly man with poorly controlled diabetes, hypertension and other chronic conditions in order to test EMR functions such as potential adverse drug reactions, disease management and treatment plans.

The functions and capabilities required for certification by CCHIT for ambulatory EMRs were developed by a panel of volunteer experts meeting in multidisciplinary Work Groups, and approved by the Commissioners. Besides specifying the criteria required in 2006, the criteria documents include a “Roadmap” forecasting additional criteria to be required in 2007 and 2008. The “Roadmap” provides guidance to providers and the industry by offering a realistic timetable for incremental improvements in EHR systems, and each year the “Roadmap” will be extended to maintain visibility two years into the future.

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Hospital Donation of Electronic Health Record to Physicians

By Michael A. Peer, CPA

In late 2006, the physician self-referral relief regulations become effective.  The intent of the regulations was to create non-monetary assistance to physicians to encourage their use of prevailing technologies.  The regulations created by the Centers for Medicare and Medicaid (CMS) and the Office of Inspector General (OIG) allows for two exceptions in the Stark law that permit hospitals to provide computer hardware and access to the hospital’s electronic health record (EHR), so long as the receipt of these items is not a condition of doing business with the hospital. Two key requirements to the hospital are that the physician cannot possess items or services equivalent to the items donated and hospital cannot limit the services to certain patients. 

Two Exceptions Provided in the Regulations

The regulations allow the following:

·         Electronic Prescribing Arrangements – hardware, software, and training services used solely to receive and transmit prescription information.

·         Electronic Health Records Arrangements – hardware, software, and training services used to create, maintain, transmit or receive an EHR.  The EHR software is required to have electronic prescribing capabilities and be interoperable at the time it is provided to the physician.  Furthermore, it must be certified as interoperable by a certifying body recognized by the Department of Health and Human Services within the last 12 months prior to providing the EHR to the physician (such as Certification Commission for Healthcare Information Technology).  CMS defines interoperable as the software is able to communicate and exchange data with different information technology systems and in such a way that the clinical meaning is not altered.

Technologies Hospitals Can Provide

·         EHR software and related licenses

·         Services that enable the physician to access the EHR such as wireless internet, but the hardware cannot be provided (modems, routers, electronic storage, etc.)

·         Data migration services

·         Clinical support and training

Cost sharing

Under the CMS regulations, the hospital may provide up to 85 percent of the cost of the hardware, software, and training.  The hospital and physician may negotiate any cost-sharing arrangement for these outlays, but the physician is required to pay at least 15 percent, but up to 100 percent of the cost outlays.  This payment must be made by the physician prior to receiving the use of the EHR not being financed by the hospital.

Special Considerations for Tax-exempt Hospitals

If you are a tax-exempt hospital, you should not only consider the CMS regulations, as outlined above, but consider pending IRS regulations of donating a portion of the EHR to a private individual or for-profit medical group.  The federal tax regulations state that “No part of the net earnings of a section 501(c)(3) organization may inure to the benefit of any private shareholder or individual. A private shareholder or individual is a person having a personal and private interest in the activities of the organization”.  While the IRS has not issued final regulations regarding these issues, hospitals should be prepared to show that this arrangement creates a community benefit or it may be includable into the physician’s income.  IRS regulations are expected to be issued in early 2007.

Hospital and Physician Agreement

A key document is the written agreement between the hospital and physician.  Following are some key components to be included in an agreement:

·         The hospital’s selection criteria of the EHR including cost information and key data supporting the selection.  Physicians may not want to pay for components that do not benefit their practice area.

·         The agreement should be specific to cost sharing agreements.  Not only will there be an initial cost, but a cost for annual updates and training that must be shared by the physician. 

·         The agreement should state how the data will be stored.  Stating whether all medical records commingled or if records for each physician maintained in “silos” must be stated in the agreement.

·         The agreement should state who specifically has the right to access the data and state if there is a limited number of users.

·         The agreement should also describe how the data will be provided to the physician should they separate from the hospital.  The physician may assume the data will be converted to another EHR, when the hospital assumes they will provide a hard copy of the record.

·         The agreement should provide an assessment of the community benefit.

·         The EHR certification of interoperability should be provided in the agreement as well as describing the EHR’s ability to provide electronic prescribing capabilities.

If your hospital is considering providing your EHR to members of the medical staff, it is important to seek legal counsel.  As indicated above, CMS, OIG and the IRS have very specific regulations that must be considered prior to commencing such an arrangement.

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