Mary Lou Ingeholm

Potential impact of HITECH security regulations on medical imaging

Title XIII of Division A and Title IV of Division B of the American Recovery and Reinvestment Act (ARRA) of 2009 [1] include a provision commonly referred to as the “Health Information Technology for Economic and Clinical Health Act” or “HITECH Act” that is intended to promote the electronic exchange of health information to improve the quality of health care. Subtitle D of the HITECH Act includes key amendments to strengthen the privacy and security regulations issued under the Health Insurance Portability and Accountability Act (HIPAA). The HITECH act also states that “the National Coordinator” must consult with the National Institute of Standards and Technology (NIST) in determining what standards are to be applied and enforced for compliance with HIPAA. This has led to speculation that NIST will recommend that the government impose the Federal Information Security Management Act (FISMA) [2], which was created by NIST for application within the federal government, as requirements to the public Electronic Health Records (EHR) community in the USA. In this paper we will describe potential impacts of FISMA on medical image sharing strategies such as teleradiology and outline how a strict application of FISMA or FISMA-based regulations could have significant negative impacts on information sharing between care providers.

The Case for Applying the Point of Care Testing Standard to Home Monitoring Devices

Diabetes is a major health concern that is growing rapidly. Daily point-of-care testing (POCT) of ones blood sugar using a glucose meter plays an integral role in managing diabetes. By integrating these self-monitoring devices with a centralized information system both patients and providers can view the blood sugar readings. This capability facilitates collaborative disease management that can lead to better control and education for the patient. In the current proprietary environment however, capturing the data stored in a glucose meter is not straightforward. Although a POCT standard has been developed to address connectivity issues for POC devices, the standard has been applied to devices used in clinic settings rather than home settings. As care of chronic diseases moves towards remote management, the need for device connectivity will propel the application of the POCT1-A standard to include devices, like glucose meters that are used outside of a clinic setting. This paper demonstrates the immediate need for standardization of connectivity to glucose meters so that patients and providers can use the readings to improve diabetes control

ImTK: An Open Source Multi-Center Information Management Toolkit

The Information Management Toolkit (ImTK) Consortium is an open source initiative to develop robust, freely available tools related to the information management needs of basic, clinical, and translational research. An open source framework and agile programming methodology can enable distributed software development while an open architecture will encourage interoperability across different environments. The ISIS Center has conceptualized a prototype data sharing network that simulates a multi-center environment based on a federated data access model. This model includes the development of software tools to enable efficient exchange, sharing, management, and analysis of multimedia medical information such as clinical information, images, and bioinformatics data from multiple data sources. The envisioned ImTK data environment will include an open architecture and data model implementation that complies with existing standards such as Digital Imaging and Communications (DICOM), Health Level 7 (HL7), and the technical framework and workflow defined by the Integrating the Healthcare Enterprise (IHE) Information Technology Infrastructure initiative, mainly the Cross Enterprise Document Sharing (XDS) specifications.

A digital imaging network to facilitate a multi-center clinical trial for adrenoleukodystrophy

Finding a large enough patient population for performing clinical trials, especially for rare diseases, can be difficult. A multi-center clinical trial allows researchers to share information and interpretation of results from multiple institutions. Using a digital network and the Internet facilitates the sharing of acquired information between many locations and becomes key to establishing a successful multi-center clinical trial. A digital magnetic resonance imaging (MRI) network of clinical institutions to evaluate therapy outcomes in a multi-center clinical trial for adrenoleukodystrophy (ALD) has been created. The network uses the DICOM 3.0 standard to move MRI images securely over the Internet and Next Generation Internet (NGI) to a secure central clinical database. Virtual private network (VPN) technology is used to protect patient confidentiality and assure data integrity. 15 sites participate in the network; 160 ALD MRI studies have been stored in the clinical database and scored independently by two physicians.

A multi-center digital MRI network for adrenoleukodystrophy (ALD)

The ability to evaluate therapy outcomes in a multi-center clinical trial for adrenoleukodystrophy (ALD) is enhanced by an electronic magnetic resonance imaging (MRI) network of clinical institutions. Brain MRI and magnetic resonance spectroscopy (MRS) are the most sensitive indices for the evaluation of ALD therapies. Using the Loes score (D.J. Loes et al., 1994), which is an objective scoring mechanism of brain MRI abnormalities, the physician can make an accurate therapy appraisal. However, because ALD is a rare disorder, it is difficult for a single institution to perform a clinical trial due to the lack of cases generated. The network allows participating sites to send ALD MRI cases to a central clinical database. By consolidating the data, a sufficient patient pool for evaluation of ALD therapies is formed. With the network in place, ALD-experienced physicians have the ability to independently summon up the ALD MRI cases remotely on softcopy display stations, review the study and provide the subsequent Loes score online in a Web-accessible database. Scoring of the MRl studies independently increases the validity of the interpretation. Implementation of this multi-center MRI network for ALD can serve as a model for many other disorders.