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29 Nov 2019

Discuss how mobile devices are used in clinical settings. What about keeping patient notes on mobile device during clinical for the student to prepare the care plan assignment. Is there a confidentiality problem here?

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Elin Hessel
Elin HesselLv2
17 Dec 2019
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Related questions

IDE Case Study

A IDE was submitted by Hyman Parts, (HP) for knee and hip replacement devices. HP informed the FDA that they had implanted a significant number of devices prior to the approval of the IDE in the hip study. These subjects did not receive informed consent nor were they aware that they had received an investigational device. HP stated that they sold these investigational devices by physician’s prescription. Based on this information the FDA decided to conduct “for cause” inspections of HP as well as the Clinical Investigators. The inspections revealed the following:

• Failure to ensure control of the investigational device.

• Failure to document and report adverse events.

• Failure to ensure the clinical investigators obtain informed consent from subjects prior to the use of the device.

• Failure to utilize IRB approved informed consent forms.

• Failure to adhere to study protocol.

Based on the inspections, the FDA took the following action:

• Issued a Warning Letter to HP.

• Issued Notices of Initiation and Disqualification Proceed in HP and Opportunity to Explain

• Letters (NIDPOE) to the Clinical Investigators

The FDA requested that no additional patients be enrolled in the study and that the HP send a patient notification letter to those who had received the device without informed consent. HP also needed to prepare a Corrective Action Plan and audit all the data from the hip study.

HP submitted a draft Audit/Corrective Action Operating Plan, however, this CAP was inadequate due to its lack of specificity in terms of actions to be taken and documentation for corrective action already made.

HP then notified the FDA that one of their hip devices that was approved in Japan not the U.S. was imported into the U.S. and implanted in 245 patients in Boston, Massachusetts and these sales were made pursuant to the physicians’ “prescriptions” as custom devices.

HP then notified the FDA that they had found similar problems as the ones documented in their hip study in their knee study

. Answer the following questions:

What are the problems that you see in this case?

What action would you take if you were representing the FDA?

What action would you take if you were representing HP?

This is assignment for hci-112 electronic health record i need the answers quickly the dead time this night:

Purpose

To assess your ability to:

Demonstrate your understanding of this week's material.

Action Items

Answer the following questions. Compose your answers in a Word Document.

It has been postulated that clinical informatics and bioinformatics are working on the same problems, but in some areas one field has made more progress than the other. Identify three common themes. Describe how the issues are approached by each sub-discipline.

Why should an awareness of bioinformatics be expected of clinical informatics professionals? Should a chapter on bioinformatics appear in a clinical informatics textbook? Explain your answers.

One major problem with introducing computers into clinical medicine is the extreme time and resource pressure placed on physicians and other health care workers. Will the same problems arise in basic biomedical research?

Why have biologists and bioinformaticians embraced the Web as a vehicle for disseminating data so quickly, whereas clinicians and clinical informaticians have been more hesitant to put their primary data online?

Highlight any risk factors that might exist, existing medical conditions, present signs and symptoms or complains that the patient is suffering from.

Analyze the results of any diagnostic tests that were performed. Diagnostic tests include, physical exams, blood test, radiologic tests (x-ray, CT scans, etc.), and other functional tests.

Relate the medical treatment used to the underlying pathology.

Propose clinical management plan for the patient’s condition, and possible prognosis.

Case Study #2 K.H. is a 67-year-old African-American man with primary hypertension and diabetes mellitus. He is currently taking an angiotensin-converting enzyme (ACE) inhibitor and following a salt-restricted weight loss diet. He is about 30 pounds over his ideal weight. At his clinic visit his blood pressure is noted to be 135/96. His heart rate is 70 beats/min. He has no complaints. His wife brought a blood pressure cuff and stethoscope with her in the hope of learning to take her husband’s blood pressure at home. A. Risk factors, diagnostic tests, treatment and clinical management plan Highlight any risk factors that might exist, existing medical conditions, present signs and symptoms or complains that the patient is suffering from. Analyze the results of any diagnostic tests that were performed. Diagnostic tests include, physical exams, blood test, radiologic tests (x-ray, CT scans, etc.), and other functional tests. Relate the medical treatment used to the underlying pathology. Propose clinical management plan for the patient’s condition, and possible prognosis. B. Discussion Questions Questions will be made available in Class. Groups will discuss and present answers. Area of focus for questions- Risk factors for hypertension; Treatment of hypertension; Use of ACE inhibitors .

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