Recommendations for Responsible Monitoring and Regulation of Clinical Software Systems

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Recommendations for Responsible Monitoring and Regulation of Clinical Software Systems

Randolph A. Miller, MD, Reed M. Gardner, PhD, the American Medical Informatics Association (AMIA), the Computer-based Patient Record Institute (CPRI), the Medical Library Association (MLA), the Association of Academic Health Science Libraries (AAHSL), the American Health Information Management Association (AHIMA), and the American Nurses Association

What the Clinical Information Systems are?

Individual computer application programs or interconnected groups of such programs, that are directly used in providing health care. They are used to track and manage patient-related information, retrieve local and general clinical information, and to apply clinical knowledge in making patient-specific decisions. Clinical system usage encompasses (hospital information systems and electronic record-keeping, clinical data repositories, health service-specific support (e.g. laboratory , pharmacy , dietary systems) , decision support for diagnosis, therapy, or prognosis , guidelines and reminders ,protocol management ,telecommunication and tele-health; signal processing (e.g., ECG interpretation systems) , image storage and analysis (e.g., picture archival and communications systems—PACS) ,advice-giving systems for patients and other health-related application.

How the relation between FDA and CIS came?

Section 201(h) of the 1976 Federal Food, Drug, and Cosmetic Act defines a medical device as any “instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component, part, or accessory, which is... intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease... or intended to affect the structure or any function of the body.” FDA asserts that CIS are “contrivances” so fall under its realm.

The role of FDA

FDA regulates medical devices that are commercial products used in patient care, devices used in the preparation or distribution of clinical biological materials (such as blood products), experimental devices used in research involving human subjects.

FDA applies its regulations in the following way: First, the FDA can “exempt” specific devices, or categories of devices, deemed to pose little or no risk. Second, the FDA employs the so-called 510(k) process—pre-market notification—for non-exempt systems.

In this process manufacturers attempt to prove that their products deemed to pose no risk to fall into low-risk (FDA Class I or Class II) category. For higher-risk (FDA Class III) pre-market approval (PMA) is required evidence for PMA s is presented in the form of controlled trials.

Is it easy to Evaluate and Monitor CIS?

Obstacles to evaluation and monitoring of CIS

•It is difficult to evaluate “Turnkey” programs which is single software products that do not connect to or depend upon other application programs

•It is also difficult to evaluate complex, Interconnected CIS as large clinical sites (such as tertiary referral centers) contain diverse hardware platforms, multiple networks, and many vendors' software products

• Evaluating CIS that change over time is more difficult because the changes occur on daily basis.

• Users: an important consideration in Evaluation and Monitoring. Problems occur when users do not understand system applicability and limitations; when users do not understand how to input critical information into the system, when users cannot reliably interpret system output.

A Consortium was held to discuss the process of Evaluation and monitoring CIS

The participating organizations were AMIA( The American Medical Informatics association) , CPRI( The Computer-based Patient Record Institute) , MLA(The Medical Library Association) , AAHSL The Association of Academic Health Sciences Libraries , AHIMA (The American Health Information Management Association) , ANA (The American Nurses Association) , ACP (The American College of Physicians) and CHIM (The Center for Health care Information Management.

The consortium came up with 5 major recommendations

Recommendation 1: Software installation and maintenance must be treated as a process, not a single event.

Recommendation 2: They recommended local oversight of clinical software systems whenever possible, through creation of Software Oversight Committees, or “SOCs”.That would be through Institutional Review Boards (IRB s) which is an example of a local monitoring process.

Recommendation 3: There should be A Focused FDA Strategy for Exemption and Regulation of Clinical Software Systems. To maximize benefit of FDA efforts, the agency should focus on those commercial stand-alone systems presenting the highest degree of clinical risk.FDA should modify certain intermediate –risk commercial products by creating an expedited process to verify that the product’s conforms to FDA standards.

Recommendation 4: They recommended adoption by health care information system vendors and local software producers of a code of good business practices. The FDA Current Good Manufacturing Procedures (CGMP s) for individual products may not work effectively for the complex software environments in large health care delivery facilities.

Recommendation 5: Health information-related organizations should work together with other groups, including clinical professional associations, vendor organizations, regulatory agencies, and user communities, to advance our understanding and knowledge of approaches to regulating and monitoring clinical software systems.


Regulation and oversight of clinical systems is both too important and too complicated to be the sole responsibility of users, vendors, or regulatory agencies so, a combined approach is required, with roles for each category of participants. There should be local oversight of clinical software systems through Software Oversight Committees (SOC s), and adoption by health care information system vendors of a code of good business practices.Budgetary and other constraints limit the type and number of systems that the FDA can regulate effectively. Most clinical software systems should be exempted from FDA regulation.FDA regulation should focus on patient-specific commercial software systems that pose high clinical risk (e.g., directly control life support systems or directly administer potentially dangerous therapies) that are not modified locally .For such “closed loop” systems, based on the degree of risk posed, the traditional FDA 510(k) notification process and full-scale pre-market approval is recommended

Retrieved from"" Eman Zaghlul